OMDP: Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02608879
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effects of a novel oral care protocol on the severity and pain of oral mucositis in patients receiving radiation and/or chemotherapy for head and neck cancers. The secondary objectives are to characterize the microbiome associated with oral mucositis, measure salivary proinflammatory cytokines, and evaluate other clinical indicators of the intervention. Participants will be enrolled prior to beginning radiation and/or chemotherapy, and will be randomized to receive either the oral health protocol or standard of care oral hygiene.

Condition or Disease	Intervention/Treatment	Phase
Oral Mucositis; Oral Cancer	Procedure: Oral Mucosa Deterging and Periodontal Debridement (OMDP); Procedure: Standard of Care Oral Hygiene Instructions; Procedure: Dental scaling, ultrasonic; Other: Chlorhexidine	N/A

Detailed Description

Oral mucositis (OM) is one of the most debilitating adverse effects in cancer patients treated with chemotherapy or radiation (RT). Currently, there are no effective therapies or prevention for mucositis, while several clinical studies have suggested that professional oral care could effectively reduce the severity of Radiation Therapy or chemotherapy-induced oral mucositis. Palliative treatment, rather than preventive or curative measures, remains the standard of care. Evidence-based guidelines do not provide consistent recommendations for the prevention, treatment and management of oral mucositis.

The investigators hypothesize that a monitored regimen of professional oral hygiene prevents harmful ecological shifts in the oral cavity, improve oral health and reduce the duration and severity of Oral Mucositis in cancer patients, consequently improving their overall quality of life during treatment. Moreover, the investigators hypothesize that the weekly oral hygiene regimen performed by an oral health professional is more effective in treating and preventing mucositis than current standard-of-care treatments.

The principal investigator of this project has developed a novel oral care regimen protocol for the treatment of oral mucositis. The "Oral Mucosa Deterging and Periodontal Debridement" (OMDP) protocol consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the debridement of the periodontium and deterging of the oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation. Co-adjuvant treatments such as intense fluoride treatments, oral hygiene instructions and palliative mouth-rinses are also part of the protocol. The hypothesis is that repeated professional prophylaxis of the oral cavity would protect the healthy oral tissue against infection and inflammation often associated with severe cases of mucositis, and consequently reduces mucositis incidence and duration.

Participants in this study would attend approximately 9 study visits over the course of 16-18 weeks, depending on their specific cancer treatment plan. Study participants will be randomized to receive either the oral health protocol, which they will receive on a weekly basis, or standard of care oral hygiene instructions and tooth brushing, preformed on a bi-weekly basis.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OMDP Group Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions.	Procedure: Oral Mucosa Deterging and Periodontal Debridement (OMDP); OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation.; Procedure: Dental scaling, ultrasonic; An ultrasonic dental scaler will be used to clean the teeth; Other: Chlorhexidine; Non-alcoholic chlorhexidine will be used as part of the OMDP protocol
Other: Control Group Subjects assigned to the control group will receive standard of care oral health instructions and will come for bi-weekly treatment visits where they will have their teeth cleaned (brushed) by a dental professional.	Procedure: Standard of Care Oral Hygiene Instructions; Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional.

Outcome Measures

Primary Outcome Measures

1. Oral Mucositis Severity - WHO Scale [End of Radiation Treatment (approximately week 7)]

   OM severity will be assessed by the WHO Oral Mucositis Scale at each follow-up visit. The WHO Oral Mucositis Scale is a 5 point scale (0 to 4) with the following scoring system: 0=None Soreness with erythema Erythema, ulcers, can eat solids Ulcers, liquid diet only Alimentation not possible

2. Oral Mucositis Severity - NCI Scale [End of Radiation Treatment (approximately week 7)]

   OM severity will be assessed by the NCI-CTCAE Scale (National Cancer Institute - Common Toxicity Criteria and Grading of Adverse Events) at each follow-up visit. The NCI-CTCAE is a 5 point scale (1-5) with the following grading system: Erythema of the mucosa Patchy ulcerations or pseudomembranes Confluent ulcerations or pseudomembranes; bleeding with minor trauma Tissue necrosis; significant spontaneous bleeding; life-threatening consequences Death

Secondary Outcome Measures

1. Level of Oral Pain (FACES Scale) [End of Radiation Treatment (approximately week 7)]

   The FACES Scale is a 6 point scale which ranges from 0-10 (and includes even numbers only). The scale is accompanied by illustrations of faces which represent each score. The subjects is shown the scale and asked to choose the face that best depicts the pain they are experiencing. 0=No hurt 2=Hurts a little bit 4=Hurts a little more 6=Hurts even more 8=Hurts a whole lot 10-Hurts the worst you could imagine

2. Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Right Side) From Baseline to Onset of Oral Mucositis [Baseline to Onset of Oral Mucositis]

   The number of each type of microbial species will be quantified and compared at each follow-up visit. Relative abundance for each species will be measured and reported. Relative abundance is a measure of the proportion of an organism of a particular kind (in this case, each microbial species) relative to the total number of organisms (the other microbial species) in the area. A positive mean value indicates that the species was present in greater quantities at baseline. A negative mean value indicates that the species was present in greater quantities at onset of oral mucositis. For this data, the top five most abundant microbial species are presented.

3. Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Left Side) From Baseline to Onset of Oral Mucositis [Baseline to Onset of Oral Mucositis]

   The number of each type of microbial species will be quantified and compared at each follow-up visit. Relative abundance for each species will be measured and reported. Relative abundance is a measure of the proportion of an organism of a particular kind (in this case, each microbial species) relative to the total number of organisms (the other microbial species) in the area. A positive mean value indicates that the species was present in greater quantities at baseline. A negative mean value indicates that the species was present in greater quantities at onset of oral mucositis. For this data, the top five most abundant microbial species are presented.

4. Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Right Side) From Baseline to Onset of Oral Mucositis [Baseline to Onset of Oral Mucositis]

   The number of each type of microbial species will be quantified and compared at each follow-up visit. Relative abundance for each species will be measured and reported. Relative abundance is a measure of the proportion of an organism of a particular kind (in this case, each microbial species) relative to the total number of organisms (the other microbial species) in the area. A positive mean value indicates that the species was present in greater quantities at baseline. A negative mean value indicates that the species was present in greater quantities at onset of oral mucositis. For this data, the top five most abundant microbial species are presented.

5. Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Left Side) From Baseline to Onset of Oral Mucositis [Baseline to Onset of Oral Mucositis]

   The number of each type of microbial species will be quantified and compared at each follow-up visit. Relative abundance for each species will be measured and reported. Relative abundance is a measure of the proportion of an organism of a particular kind (in this case, each microbial species) relative to the total number of organisms (the other microbial species) in the area. A positive mean value indicates that the species was present in greater quantities at baseline. A negative mean value indicates that the species was present in greater quantities at onset of oral mucositis. For this data, the top five most abundant microbial species are presented.

6. Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks [Baseline and 16 weeks (final study visit)]

   The level of salivary proinflammatory cytokines will be compared between the two groups at each follow-up visit.

7. Change in Quality of Life as Measured by the Composite Score of the EORTC [Baseline to the peak of mucositis (approximately week 4)]

   Quality of life will be measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC) and Head & Neck module (EORTC-H&N) and compared between the two groups at each follow-up visit. There is not a single composite score for the entire questionnaire, but rather composite scores for each type of assessment (e.g. physical functioning, global health, swallowing, etc.). Possible scores range from 0-100. A lower score indicates low levels of that trait, which a higher score indicates high levels of that trait (e.g. a 100 for "physical functioning" indicates a high level of physical function).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male and female patient aged 18 years or older;

2. Patients must sign an informed consent before data collection, screening, or initiation of study procedures;

3. Patients who are scheduled to undergo radiation or chemoradiation treatment for head/neck cancer;

4. Patients who have a minimum of 6 natural teeth at the time of enrollment.

Exclusion Criteria:

1. Female patients who are pregnant or lactating at the baseline/screening visit;

2. Patient participating in another biomedical/oral health research study that would interfere with participating in this study;

3. Patient deprived of freedom, under supervision or guardianship;

4. Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons;

5. Immune compromised or other serious medical conditions, regardless of whether the condition is controlled or not;

6. Patient who requires pre-medication prior to dental treatment;

7. Any patient, in the opinion of the Investigator, who is unable or unlikely to comply fully with the study requirements or procedures for any reason (e.g. major surgical resection of intra-oral structures which would prevent oral care intervention, edentulous, severe periodontal disease, etc).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Medical Center	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Patricia Corby, DDS, MS, NYU Langone Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02608879
• Other Study ID Numbers: 14-00082
• First Posted: Nov 20, 2015
• Last Update Posted: Aug 28, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by NYU Langone Health: proinflammatory cytokines; microbiome; radiation therapy
• Additional relevant MeSH terms: Mouth Neoplasms; Mucositis; Stomatitis; Chlorhexidine

Study Results

Participant Flow

Arm/Group Title	OMDP Group	Control Group	Not Randomized
Arm/Group Description	Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions. Oral Mucosa Deterging and Periodontal Debridement (OMDP): OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation. Dental scaling, ultrasonic: An ultrasonic dental scaler will be used to clean the teeth Chlorhexidine: Non-alcoholic chlorhexidine will be used as part of the OMDP protocol	Subjects assigned to the control group will receive standard of care oral health instructions and will come for bi-weekly treatment visits where they will have their teeth cleaned (brushed) by a dental professional. Standard of Care Oral Hygiene Instructions: Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional.	Subjects in this study were randomized at the time oral mucositis (OM) was developed (approximately week 2-4). Subjects who met inclusion criteria at the time of enrollment, but did not meet continuation criteria at the time OM was developed were not randomized and were dropped from the study.
Period Title: Overall Study
STARTED	10	6	3
COMPLETED	9	6	0
NOT COMPLETED	1	0	3

Baseline Characteristics

Arm/Group Title	OMDP Group	Control Group	Not Randomized	Total
Arm/Group Description	Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions. Oral Mucosa Deterging and Periodontal Debridement (OMDP): OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation. Dental scaling, ultrasonic: An ultrasonic dental scaler will be used to clean the teeth Chlorhexidine: Non-alcoholic chlorhexidine will be used as part of the OMDP protocol	Subjects assigned to the control group will receive standard of care oral health instructions and will come for bi-weekly treatment visits where they will have their teeth cleaned (brushed) by a dental professional. Standard of Care Oral Hygiene Instructions: Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional.	Subjects in this study were randomized at the time oral mucositis (OM) was developed (approximately week 2-4). Subjects who met inclusion criteria at the time of enrollment, but did not meet continuation criteria at the time OM was developed were not randomized and were dropped from the study.	Total of all reporting groups
Overall Participants	10	6	3	19
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	55.8	55.5	67.33	57.5
Sex: Female, Male (Count of Participants)
Female	4 40%	2 33.3%	1 33.3%	7 36.8%
Male	6 60%	4 66.7%	2 66.7%	12 63.2%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaskan	0 0%	1 16.7%	0 0%	1 5.3%
Asian or Pacific Islander	1 10%	0 0%	0 0%	1 5.3%
Black, not of Hispanic-American Origin	1 10%	1 16.7%	0 0%	2 10.5%
Hispanic-American	1 10%	0 0%	0 0%	1 5.3%
White, not of Hispanic-American Origin	6 60%	4 66.7%	1 33.3%	11 57.9%
Other/Unknown	1 10%	0 0%	2 66.7%	3 15.8%

Outcome Measures

1. Primary Outcome

Title	Oral Mucositis Severity - WHO Scale
Description	OM severity will be assessed by the WHO Oral Mucositis Scale at each follow-up visit. The WHO Oral Mucositis Scale is a 5 point scale (0 to 4) with the following scoring system: 0=None Soreness with erythema Erythema, ulcers, can eat solids Ulcers, liquid diet only Alimentation not possible
Time Frame	End of Radiation Treatment (approximately week 7)

Outcome Measure Data

Analysis Population Description

Data from the one participant in the OMDP group who was lost to follow up was not analyzed for this measure.

Arm/Group Title	OMDP Group	Control Group
Arm/Group Description	Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions. Oral Mucosa Deterging and Periodontal Debridement (OMDP): OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation. Dental scaling, ultrasonic: An ultrasonic dental scaler will be used to clean the teeth Chlorhexidine: Non-alcoholic chlorhexidine will be used as part of the OMDP protocol	Subjects assigned to the control group will receive standard of care oral health instructions and will come for bi-weekly treatment visits where they will have their teeth cleaned (brushed) by a dental professional. Standard of Care Oral Hygiene Instructions: Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional.
Measure Participants	9	6
WHO score of 0	3 30%	3 50%
WHO score of 1	0 0%	0 0%
WHO score of 2	6 60%	2 33.3%
WHO score of 3	0 0%	0 0%
WHO score of 4	0 0%	1 16.7%

2. Primary Outcome

Title	Oral Mucositis Severity - NCI Scale
Description	OM severity will be assessed by the NCI-CTCAE Scale (National Cancer Institute - Common Toxicity Criteria and Grading of Adverse Events) at each follow-up visit. The NCI-CTCAE is a 5 point scale (1-5) with the following grading system: Erythema of the mucosa Patchy ulcerations or pseudomembranes Confluent ulcerations or pseudomembranes; bleeding with minor trauma Tissue necrosis; significant spontaneous bleeding; life-threatening consequences Death
Time Frame	End of Radiation Treatment (approximately week 7)

Outcome Measure Data

Analysis Population Description

Data from the one participant in the OMDP group who was lost to follow up was not analyzed for this measure.

Arm/Group Title	OMDP Group	Control Group
Arm/Group Description	Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions. Oral Mucosa Deterging and Periodontal Debridement (OMDP): OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation. Dental scaling, ultrasonic: An ultrasonic dental scaler will be used to clean the teeth Chlorhexidine: Non-alcoholic chlorhexidine will be used as part of the OMDP protocol	Subjects assigned to the control group will receive standard of care oral health instructions and will come for bi-weekly treatment visits where they will have their teeth cleaned (brushed) by a dental professional. Standard of Care Oral Hygiene Instructions: Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional.
Measure Participants	9	6
CTCAE score of 1	6 60%	3 50%
CTCAE score of 2	2 20%	1 16.7%
CTCAE score of 3	1 10%	2 33.3%
CTCAE score of 4	0 0%	0 0%
CTCAE score of 5	0 0%	0 0%

3. Secondary Outcome

Title	Level of Oral Pain (FACES Scale)
Description	The FACES Scale is a 6 point scale which ranges from 0-10 (and includes even numbers only). The scale is accompanied by illustrations of faces which represent each score. The subjects is shown the scale and asked to choose the face that best depicts the pain they are experiencing. 0=No hurt 2=Hurts a little bit 4=Hurts a little more 6=Hurts even more 8=Hurts a whole lot 10-Hurts the worst you could imagine
Time Frame	End of Radiation Treatment (approximately week 7)

Outcome Measure Data

Analysis Population Description

Data from the one participant in the OMDP group who was lost to follow up was not analyzed for this measure.

Arm/Group Title	OMDP Group	Control Group
Arm/Group Description	Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions. Oral Mucosa Deterging and Periodontal Debridement (OMDP): OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation. Dental scaling, ultrasonic: An ultrasonic dental scaler will be used to clean the teeth Chlorhexidine: Non-alcoholic chlorhexidine will be used as part of the OMDP protocol	Subjects assigned to the control group will receive standard of care oral health instructions and will come for bi-weekly treatment visits where they will have their teeth cleaned (brushed) by a dental professional. Standard of Care Oral Hygiene Instructions: Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional.
Measure Participants	9	6
FACES score of 0	0 0%	1 16.7%
FACES score of 2	6 60%	3 50%
FACES score of 4	1 10%	1 16.7%
FACES score of 6	1 10%	1 16.7%
FACES score of 8	1 10%	0 0%
FACES score of 10	0 0%	0 0%

4. Secondary Outcome

Title	Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Right Side) From Baseline to Onset of Oral Mucositis
Description	The number of each type of microbial species will be quantified and compared at each follow-up visit. Relative abundance for each species will be measured and reported. Relative abundance is a measure of the proportion of an organism of a particular kind (in this case, each microbial species) relative to the total number of organisms (the other microbial species) in the area. A positive mean value indicates that the species was present in greater quantities at baseline. A negative mean value indicates that the species was present in greater quantities at onset of oral mucositis. For this data, the top five most abundant microbial species are presented.
Time Frame	Baseline to Onset of Oral Mucositis

Outcome Measure Data

Analysis Population Description

Data were only collected for the OMDP Grouip because they are the only group that developed oral mucositis.

Arm/Group Title	OMDP Group
Arm/Group Description	Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions.
Measure Participants	9
Stomatobaculum sp oral taxon 97	2.6517
Leptotrichia sp oral taxon	1.8354
Haemophillus Genus probe 3	-2.2123
Veillonella Genus probe 2	-0.9269246
Gemella Haemolysans	-0.7559120

5. Secondary Outcome

Title	Mean Difference in the Relative Abundance of Oral Microbial Species of the Cheek (Left Side) From Baseline to Onset of Oral Mucositis
Description	The number of each type of microbial species will be quantified and compared at each follow-up visit. Relative abundance for each species will be measured and reported. Relative abundance is a measure of the proportion of an organism of a particular kind (in this case, each microbial species) relative to the total number of organisms (the other microbial species) in the area. A positive mean value indicates that the species was present in greater quantities at baseline. A negative mean value indicates that the species was present in greater quantities at onset of oral mucositis. For this data, the top five most abundant microbial species are presented.
Time Frame	Baseline to Onset of Oral Mucositis

Outcome Measure Data

Analysis Population Description

This outcome measure was only collected in the OMDP Group because this is the only arm where participants developed Oral Mucositis. Two subjects were excluded from this analysis due to a diagnosis of HIV, which the investigator determined would alter the microbial makeup of the oral cavity.

Arm/Group Title	OMDP Group
Arm/Group Description	Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions.
Measure Participants	9
Fusobacterium periodonticum	2.3367705
Leptotrichia sp oral taxon 417	1.7988509
Stomatobaculum sp oral taxon 97	2.5104787
Gemella Haemolysans	-0.6947840
Prevotella histicolla	-0.8316186

6. Secondary Outcome

Title	Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Right Side) From Baseline to Onset of Oral Mucositis
Description	The number of each type of microbial species will be quantified and compared at each follow-up visit. Relative abundance for each species will be measured and reported. Relative abundance is a measure of the proportion of an organism of a particular kind (in this case, each microbial species) relative to the total number of organisms (the other microbial species) in the area. A positive mean value indicates that the species was present in greater quantities at baseline. A negative mean value indicates that the species was present in greater quantities at onset of oral mucositis. For this data, the top five most abundant microbial species are presented.
Time Frame	Baseline to Onset of Oral Mucositis

Outcome Measure Data

Analysis Population Description

This outcome measure was only collected in the OMDP Group because this is the only arm where participants developed Oral Mucositis. Two subjects were excluded from this analysis due to a diagnosis of HIV, which the investigator determined would alter the microbial makeup of the oral cavity.

Arm/Group Title	OMDP Group
Arm/Group Description	Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions.
Measure Participants	9
Haemophillus Genus probe 3	-3.545091
Gemella Haemolysans	-2.1439002
Streptococcus Genus probe 1	-0.9359749
Leptotrichia sp oral taxon 417	1.3618774
Gemella Sanguinis	2.9317234

7. Secondary Outcome

Title	Mean Difference in the Relative Abundance of Oral Microbial Species of the Tongue (Left Side) From Baseline to Onset of Oral Mucositis
Description	The number of each type of microbial species will be quantified and compared at each follow-up visit. Relative abundance for each species will be measured and reported. Relative abundance is a measure of the proportion of an organism of a particular kind (in this case, each microbial species) relative to the total number of organisms (the other microbial species) in the area. A positive mean value indicates that the species was present in greater quantities at baseline. A negative mean value indicates that the species was present in greater quantities at onset of oral mucositis. For this data, the top five most abundant microbial species are presented.
Time Frame	Baseline to Onset of Oral Mucositis

Outcome Measure Data

Analysis Population Description

This outcome measure was only collected in the OMDP Group because this is the only arm where participants developed Oral Mucositis. Two subjects were excluded from this analysis due to a diagnosis of HIV, which the investigator determined would alter the microbial makeup of the oral cavity.

Arm/Group Title	OMDP Group
Arm/Group Description	Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions.
Measure Participants	9
Gemella Sanguinis	3.1061673
Stomatobaculum sp oral taxon 97	3.6522501
Fusobacterium periodonticum	2.8036767
Gemella Haemolysans	-1.5662996
Haemophillus Genus probe 3	-2.9178458

8. Secondary Outcome

Title	Change in the Level of Salivary Proinflammatory Cytokines From Baseline to 16 Weeks
Description	The level of salivary proinflammatory cytokines will be compared between the two groups at each follow-up visit.
Time Frame	Baseline and 16 weeks (final study visit)

Outcome Measure Data

Analysis Population Description

Due to financial limitations, not all data could be analyzed at this time. Samples were collected and may be analyzed at a later point. Analyzed samples were limited to those collected from subjects with oropharyngeal cancer (i.e. samples from subjects with cancer of the oral cavity were not analyzed at this time).

Arm/Group Title	OMDP Group	Control Group
Arm/Group Description	Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions. Oral Mucosa Deterging and Periodontal Debridement (OMDP): OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation. Dental scaling, ultrasonic: An ultrasonic dental scaler will be used to clean the teeth Chlorhexidine: Non-alcoholic chlorhexidine will be used as part of the OMDP protocol	Subjects assigned to the control group will receive standard of care oral health instructions and will come for bi-weekly treatment visits where they will have their teeth cleaned (brushed) by a dental professional. Standard of Care Oral Hygiene Instructions: Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional.
Measure Participants	5	5
IFN-ɣ	-0.7228 (0.18)	0.5782 (0.5782)
IL-1	-0.7184 (0.3918)	0.5747 (0.5747)
IL-10	-0.4503 (0.0823)	0.3603 (0.3603)
IL-12p70	-0.4503 (0.0823)	0.3603 (0.3603)
IL-13	-0.8873 (0.2511)	0.7099 (0.7099)
IL-2	-0.2754 (0.0142)	0.2203 (0.2203)
IL-4	-0.3639 (1.3222)	0.2911 (0.2911)
IL-6	-0.5358 (0.9856)	0.4286 (0.4286)
IL-8	-0.7407 (0.2868)	0.5925 (0.5925)
TNF-α	-0.5881 (0.0627)	0.4705 (0.4705)

9. Secondary Outcome

Title	Change in Quality of Life as Measured by the Composite Score of the EORTC
Description	Quality of life will be measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC) and Head & Neck module (EORTC-H&N) and compared between the two groups at each follow-up visit. There is not a single composite score for the entire questionnaire, but rather composite scores for each type of assessment (e.g. physical functioning, global health, swallowing, etc.). Possible scores range from 0-100. A lower score indicates low levels of that trait, which a higher score indicates high levels of that trait (e.g. a 100 for "physical functioning" indicates a high level of physical function).
Time Frame	Baseline to the peak of mucositis (approximately week 4)

Outcome Measure Data

Analysis Population Description

Only data from subjects with oropharyngeal cancer were included in this analysis.

Arm/Group Title	OMDP Group	Control Group
Arm/Group Description	Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions. Oral Mucosa Deterging and Periodontal Debridement (OMDP): OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation. Dental scaling, ultrasonic: An ultrasonic dental scaler will be used to clean the teeth Chlorhexidine: Non-alcoholic chlorhexidine will be used as part of the OMDP protocol	Subjects assigned to the control group will receive standard of care oral health instructions and will come for bi-weekly treatment visits where they will have their teeth cleaned (brushed) by a dental professional. Standard of Care Oral Hygiene Instructions: Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional.
Measure Participants	5	5
Physical Functioning Score	11.7 (8.4)	-3.9 (6.1)
Global Health Status	-20.9 (16)	-3.4 (7.3)
H&N Swallowing Scale	2 (23.1)	-10 (22.1)

Adverse Events

Arm/Group Title	OMDP Group		Control Group		Not Randomized
Arm/Group Description	Subjects randomized to this group will attend weekly visits and receive a full dental cleaning, as well as have their gums/tongue cleaned by a dental professional. Subjects will also receive standard of care oral hygiene instructions. Oral Mucosa Deterging and Periodontal Debridement (OMDP): OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation. Dental scaling, ultrasonic: An ultrasonic dental scaler will be used to clean the teeth Chlorhexidine: Non-alcoholic chlorhexidine will be used as part of the OMDP protocol		Subjects assigned to the control group will receive standard of care oral health instructions and will come for bi-weekly treatment visits where they will have their teeth cleaned (brushed) by a dental professional. Standard of Care Oral Hygiene Instructions: Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional.		Subjects in this study were randomized at the time oral mucositis (OM) was developed (approximately week 2-4). Subjects who met inclusion criteria at the time of enrollment, but did not meet continuation criteria at the time OM was developed were not randomized and were dropped from the study.
All Cause Mortality
	OMDP Group		Control Group		Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	OMDP Group		Control Group		Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		0/6 (0%)		1/3 (33.3%)
Cardiac disorders
Myocardial Infarction	0/10 (0%)	0	0/6 (0%)	0	1/3 (33.3%)	1
Hepatobiliary disorders
Abnormal liver function	1/10 (10%)	1	0/6 (0%)	0	0/3 (0%)	0
Other (Not Including Serious) Adverse Events
	OMDP Group		Control Group		Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/10 (100%)		6/6 (100%)		2/3 (66.7%)
Blood and lymphatic system disorders
Edema	1/10 (10%)		0/6 (0%)		0/3 (0%)
Lymphoedema	0/10 (0%)		1/6 (16.7%)		0/3 (0%)
Ear and labyrinth disorders
Tinnitus	1/10 (10%)		0/6 (0%)		0/3 (0%)
Hearing loss	1/10 (10%)		0/6 (0%)		0/3 (0%)
Gastrointestinal disorders
Oral Mucositis	10/10 (100%)		6/6 (100%)		2/3 (66.7%)
Dry Mouth/throat	7/10 (70%)		5/6 (83.3%)		0/3 (0%)
Sore throat	1/10 (10%)		3/6 (50%)		0/3 (0%)
Nausea	7/10 (70%)		3/6 (50%)		0/3 (0%)
Cacogeusia	0/10 (0%)		1/6 (16.7%)		0/3 (0%)
Dysgeusia	1/10 (10%)		1/6 (16.7%)		0/3 (0%)
Vomiting	1/10 (10%)		0/6 (0%)		0/3 (0%)
Hiccups with acid reflux	1/10 (10%)		0/6 (0%)		0/3 (0%)
Heartburn	1/10 (10%)		0/6 (0%)		0/3 (0%)
Constipation	1/10 (10%)		0/6 (0%)		0/3 (0%)
Hypogeusia	1/10 (10%)		0/6 (0%)		0/3 (0%)
Burning on the tongue	1/10 (10%)		0/6 (0%)		0/3 (0%)
General disorders
Allergic reaction	1/10 (10%)		1/6 (16.7%)		0/3 (0%)
Dehydration	1/10 (10%)		0/6 (0%)		0/3 (0%)
Fatigue	0/10 (0%)		1/6 (16.7%)		1/3 (33.3%)
Infections and infestations
Candidiasis	5/10 (50%)		2/6 (33.3%)		1/3 (33.3%)
Shingles	0/10 (0%)		1/6 (16.7%)		0/3 (0%)
Herpetic lesion	1/10 (10%)		0/6 (0%)		0/3 (0%)
Musculoskeletal and connective tissue disorders
Shoulder pain	1/10 (10%)		0/6 (0%)		0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Bronchitis	0/10 (0%)		1/6 (16.7%)		0/3 (0%)
Cold/flu	1/10 (10%)		0/6 (0%)		0/3 (0%)
Skin and subcutaneous tissue disorders
Radiation dermatitis	0/10 (0%)		2/6 (33.3%)		0/3 (0%)
Surgical and medical procedures
Chemotherapy induced rash	1/10 (10%)		0/6 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.