Effect of Oxygenated Mouthwash and Mouth Foam
Study Details
Study Description
Brief Summary
The Aim of this independent, parallel, twelve-week clinical study is to assess the efficacy of a commercially available oxygenated mouth rinse and mouth foam on both plaque level and gingival status in addition to assessing the oral health related quality of life.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Participants in all groups will be examined for gingival inflammation and plaque accumulation. The difference between three trial arms lies in the product used (control, oxygenated mouth wash, oxygenated mouth foam). A comparison against no intervention was disregarded due to ethical concerns (children only examined without informing them about their oral problems). After examination at baseline participants will be assigned to one arm of intervention. All participants will be provided an oral health education and gingival scaling to remove any underlining predisposing factor for gingival inflammation as well as fluoridated toothpaste and a toothbrush. Participants within intervention arms will also be provided the product package and informed how to use it (oxygenated mouth wash, oxygenated mouth foam).
All three arms will be followed after (1week, 2 weeks, 4 weeks, 8 weeks and 12 weeks) from baseline examination.
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Control group Won't receive an oxygenated mouthwash nor oxygenated mouth foam (20 participants) 2. Intervention Group A: 20 participants - 2 oxygenated mouthwash bottle per individual for 3 months (40 bottles in total).
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Intervention Group B: Oxygenated mouth foam/ day 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months (40 bottles in total).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Won't receive an oxygenated mouthwash nor oxygenated mouth foam yet will be provided a fluoridated toothpaste and a toothbrush (20 participants) |
|
| Experimental: Oxygenated mouthwash Group Provided with oxygenated mouthwash bottle 2 per individual for 3 months (40 bottles in total). -20 participants - |
Other: Oxygenated Mouthwash
Will be comparing the impact of using oxygenated mouthwash with other groups.
|
| Experimental: Oxygenated mouth foam Group Provided with oxygenated mouth foam/ day- 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months (40 bottles in total). |
Other: Oxygenated mouth foam
will be comparing the impact of using oxygenated foam to other groups.
|
Outcome Measures
Primary Outcome Measures
- Gingival index [baseline]
Gingival index has been used to clinically characterize the degree of gingival inflammation. were the scale range 0-3. zero indicating the best results and 3 as sever gingivitis.
- Gingival index [+1 week from baseline]
Gingival index has been used to clinically characterize the degree of gingival inflammation. were the scale range 0-3. zero indicating the best results and 3 as sever gingivitis.
- Gingival index [+2 weeks from baseline]
Gingival index has been used to clinically characterize the degree of gingival inflammation. were the scale range 0-3. zero indicating the best results and 3 as sever gingivitis.
- Gingival index [+4 weeks from baseline]
Gingival index has been used to clinically characterize the degree of gingival inflammation. were the scale range 0-3. zero indicating the best results and 3 as sever gingivitis.
- Gingival index [+8 weeks from baseline]
Gingival index has been used to clinically characterize the degree of gingival inflammation. were the scale range 0-3. zero indicating the best results and 3 as sever gingivitis.
- Gingival index [+12 weeks from baseline]
Gingival index has been used to clinically characterize the degree of gingival inflammation. were the scale range 0-3. zero indicating the best results and 3 as sever gingivitis.
- Plaque index [baseline]
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation.
- Plaque index [+1 week from baseline]
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
- Plaque index [+2 weeks from baseline]
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
- Plaque index [+4 weeks from baseline]
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
- Plaque index [+8 weeks from baseline]
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
- Plaque index [+12 weeks from baseline]
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Secondary Outcome Measures
- Gum Health Experience Questionnaire (GHEQ) [Baseline]
The questions are designed to assess the impact that gum-related symptoms may have on your everyday life. (Assessed through Likert scale were the 5 is the highest score and 1 is the lowest score)
- Gum Health Experience Questionnaire (GHEQ) [+12 weeks from baseline]
The questions are designed to assess the impact that gum-related symptoms may have on your everyday life. (Assessed through Likert scale were the 5 is the highest score and 1 is the lowest score)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Students and employees at College of applied Medical science over 19 years old
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Both Saudis and non-Saudis.
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Students and employees consenting to participate.
Exclusion Criteria:
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Intern students or students in their 1st year.
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Students and employees with medically compromised condition (including congenital heart disease, hematological condition, immune deficiency condition and end stage renal disease or those with organ transplant within the previous 5 year.
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Students and employees not consenting to participate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Haya Mahmmod Alayadi | Riyadh | Saudi Arabia | 4312 |
Sponsors and Collaborators
- King's College London
- King Saud University
Investigators
- Principal Investigator: Haya M Alayadi, PhD, King Saud University
Study Documents (Full-Text)
None provided.More Information
Publications
- Allen F, Locker D. A modified short version of the oral health impact profile for assessing health-related quality of life in edentulous adults. Int J Prosthodont. 2002 Sep-Oct;15(5):446-50.
- Broomhead T, Gibson B, Parkinson CR, Vettore MV, Baker SR. Gum health and quality of life-subjective experiences from across the gum health-disease continuum in adults. BMC Oral Health. 2022 Nov 18;22(1):512. doi: 10.1186/s12903-022-02507-5.
- Broomhead T, Gibson BJ, Parkinson C, Robinson PG, Vettore MV, Baker SR. Development and psychometric validation of the gum health experience questionnaire. J Clin Periodontol. 2023 Sep 21. doi: 10.1111/jcpe.13878. Online ahead of print.
- Ciancio SG. Current status of indices of gingivitis. J Clin Periodontol. 1986 May;13(5):375-8, 381-2. doi: 10.1111/j.1600-051x.1986.tb01476.x.
- Fischman SL. Current status of indices of plaque. J Clin Periodontol. 1986 May;13(5):371-4, 379-80. doi: 10.1111/j.1600-051x.1986.tb01475.x.
- E-23- KSU-1001