Clinical Evaluation of Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Gum Disease

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT04027686
• Collaborator: Biolase Inc (Industry)
• Enrollment: 23
• Arms: 2
• Actual Duration (Months): 35

Study Details

Study Description

Brief Summary

The use of lasers to treat various problems in dentistry is growing as it has in medicine. One application is the use of lasers to treat periodontal disease. It has been suggested that the laser may reduce the need for surgical treatment by reducing pockets. The goal of this study is to evaluate the effectiveness of laser treatment for periodontal disease. Laser therapy will be used in addition to traditional non-surgical scaling and root planing (deep cleaning). The information obtained from this study will provide an objective assessment of adjunctive laser therapy compared to conventional periodontal therapy and will attempt to show the benefits, if any, lasers can provide in the treatment of chronic periodontal disease.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis Chronic Generalized Moderate; Periodontitis Chronic Generalized Severe	Device: Laser Therapy; Procedure: Non-surgical Scaling and Root Planing	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, Controlled, Split-mouthRandomized, Controlled, Split-mouth
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of WaterLase (iPlus) Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Chronic Periodontitis: A Randomized, Controlled, Split-Mouth Clinical Study
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SRP + Adjunctive Laser Therapy Laser therapy used as an adjunct to scaling and root planing	Device: Laser Therapy; Adjunctive application of laser therapy in the periodontal pocket; Procedure: Non-surgical Scaling and Root Planing; Scaling to remove calculus deposits and root planing to smooth root surfaces
Active Comparator: SRP alone Scaling and root planing used as conventional non-surgical periodontal therapy	Procedure: Non-surgical Scaling and Root Planing; Scaling to remove calculus deposits and root planing to smooth root surfaces

Outcome Measures

Primary Outcome Measures

1. Probing Pocket Depth [12 months]

   This is a measure from base of pocket to gingival margin.

2. Sites That Bleed on Probing [12 months]

   Percentage of sites that bleed in response to probing. Bleeding observed within 30 seconds from pocket/sulcus following periodontal probe measurement.

3. Gingival Recession [12 months]

   Measure of gingival recession following treatment. This is a measure of the gingival margin from the cement-enamel junction.

4. Clinical Attachment Level [12 months]

   Periodontal clinical attachment level following treatment. This is a calculation (clinical attachment level = probing pocket depth + gingival recession).

Secondary Outcome Measures

1. Periodontal Microbiome [12 months]

   Assess changes in periodontal microbiome using DNA sequencing

2. Patient Reported Outcomes: VAS Questionnaire [12 months]

   Measure patient reported pain (0-100), comfort (0-100), sensitivity (0-100) and satisfaction (0-100) using VAS questionnaire, with lower values indicating better outcome for pain and sensitivity and higher values indicating better outcome for comfort and satisfaction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 18 years old or older (male or female)

• Healthy without systemic diseases that may adversely effect healing

• Not pregnant and no current plans to become pregnant

• No periodontal treatment in the previous 12 months

• No systemic antibiotic therapy in the previous 6 months

• At least two quadrants with periodontitis (ideally opposite side same jaw)

• Each quadrant must have two or more sites with probing pocket depths ≥ 5mm

• Each quadrant should include interproximal intrabony defect(s)

Exclusion criteria:

• Any systemic disease, medication, or habit known to adversely influence bone metabolism and/or wound healing:

• Poorly controlled diabetes (HbA1c > 7%)

• History of bisphosphonate medications

• History of radiation therapy affecting the proposed treatment site(s)

• History of immunosuppressive medications (e.g. corticosteroids)

• History of tobacco use (current or past tobacco use within the past 1 year)

• Immune compromise caused by disease, treatment or other condition

• Recent history of periodontal surgery (within the previous 2 years)

• Recent history of scaling and root planing (within the previous 12 months)

• Any condition that contraindicates periodontal therapy including surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of California, Los Angeles
• Biolase Inc

Investigators

• Principal Investigator: Perry R Klokkevold, DDS, MS, UCLA School of Dentistry, Section of Periodontics

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 30, 2016

More Information

Publications

None provided.

• Responsible Party: Perry R Klokkevold, DDS, MS, Professor of Clinical Dentistry, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT04027686
• Other Study ID Numbers: IRB#15-000519
• First Posted: Jul 22, 2019
• Last Update Posted: Mar 5, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Perry R Klokkevold, DDS, MS, Professor of Clinical Dentistry, University of California, Los Angeles: Laser Therapy; Non-surgical periodontal therapy; Scaling and root planing
• Additional relevant MeSH terms: Periodontitis

Study Results

Participant Flow

Arm/Group Title	Periodontal Sites Assigned to SRP or SRP + Adjunctive Laser Therapy	Pilot Procedure Arm
Arm/Group Description	Each participant had one or more periodontal sites randomly assigned to scaling and root planing only (Standard of Care) or to Laser therapy in addition to scaling and root planing	Preliminary enrollment of individuals to pilot-test the protocol
Period Title: Overall Study
STARTED	17	6
COMPLETED	15	5
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Periodontal Sites Assigned to SRP + Adjunctive Laser Therapy or SRP Alone	Pilot Procedure Arm	Total
Arm/Group Description	Enrolled participants each had multiple periodontal sites randomly assigned to receive scaling and root planing as conventional non-surgical periodontal therapy, or Laser therapy as an adjunct to scaling and root planing.	Preliminary enrollment of individuals to pilot-test the protocol	Total of all reporting groups
Overall Participants	17	6	23
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 94.1%	6 100%	22 95.7%
>=65 years	1 5.9%	0 0%	1 4.3%
Sex: Female, Male (Count of Participants)
Female	12 70.6%	2 33.3%	14 60.9%
Male	5 29.4%	4 66.7%	9 39.1%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	17 100%	6 100%	17 73.9%

Outcome Measures

1. Primary Outcome

Title	Probing Pocket Depth
Description	This is a measure from base of pocket to gingival margin.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

15 participants had a total of 90 periodontal pockets, randomized 45 to Test and 45 to Control interventions. Each site had one buccal and one lingual measurement, with measures < 4mm excluded from analyses. The preliminary pilot participants were not assessed for outcome measures.

Arm/Group Title	SRP + Adjunctive Laser Therapy	SRP Alone	Pilot Procedure Arm
Arm/Group Description	Laser therapy used as an adjunct to scaling and root planing	Scaling and root planing used as conventional non-surgical periodontal therapy	Preliminary enrollment of individuals to pilot-test the protocol
Measure Participants	15	15	0
Measure Periodontal pockets	78	77	0
Mean (Standard Deviation) [mm]	4.167 (0.986)	4.273 (1.232)

2. Primary Outcome

Title	Sites That Bleed on Probing
Description	Percentage of sites that bleed in response to probing. Bleeding observed within 30 seconds from pocket/sulcus following periodontal probe measurement.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

15 participants had a total of 90 periodontal pockets, randomized 45 to Test and 45 to Control interventions. Each site had one buccal and one lingual measurement, with measures <4mm excluded from analyses. Pilot enrollees were not assessed for outcome measures.

Arm/Group Title	SRP + Adjunctive Laser Therapy	SRP Alone	Pilot Procedure Arm
Arm/Group Description	Laser therapy used as an adjunct to scaling and root planing	Scaling and root planing used as conventional non-surgical periodontal therapy	Preliminary enrollment of individuals to pilot-test the protocol
Measure Participants	15	15	0
Measure Periodontal pockets	78	77	0
Number [percentage of sites with bleeding]	55.1	63.6

3. Primary Outcome

Title	Gingival Recession
Description	Measure of gingival recession following treatment. This is a measure of the gingival margin from the cement-enamel junction.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

15 participants had a total of 90 periodontal pockets, randomized 45 to Test and 45 to Control interventions. Each site had one buccal and one lingual measurement, with measures <4mm excluded from analyses. Pilot enrollees were not assessed for outcome measures.

Arm/Group Title	SRP + Adjunctive Laser Therapy	SRP Alone	Pilot Procedure Arm
Arm/Group Description	Laser therapy used as an adjunct to scaling and root planing	Scaling and root planing used as conventional non-surgical periodontal therapy	Preliminary enrollment of individuals to pilot-test the protocol
Measure Participants	15	15	0
Measure Periodontal pockets	78	77	0
Mean (Standard Deviation) [mm]	1.167 (1.263)	1.182 (1.305)

4. Primary Outcome

Title	Clinical Attachment Level
Description	Periodontal clinical attachment level following treatment. This is a calculation (clinical attachment level = probing pocket depth + gingival recession).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

15 participants had a total of 90 periodontal pockets, randomized 45 to Test and 45 to Control interventions. Each site had one buccal and one lingual measurement, with measures <4mm excluded from analyses. Pilot enrollees were not assessed for outcome measures.

Arm/Group Title	SRP + Adjunctive Laser Therapy	SRP Alone	Pilot Procedure Arm
Arm/Group Description	Laser therapy used as an adjunct to scaling and root planing	Scaling and root planing used as conventional non-surgical periodontal therapy	Preliminary enrollment of individuals to pilot-test the protocol
Measure Participants	15	15	0
Measure Periodontal pockets	78	77	0
Mean (Standard Deviation) [mm]	5.346 (1.578)	5.455 (1.766)

5. Secondary Outcome

Title	Periodontal Microbiome
Description	Assess changes in periodontal microbiome using DNA sequencing
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Microbiome results will not be available for analysis until April 2021

Arm/Group Title	SRP + Adjunctive Laser Therapy	SRP Alone
Arm/Group Description	Laser therapy used as an adjunct to scaling and root planing Laser Therapy: Adjunctive application of laser therapy in the periodontal pocket Non-surgical Scaling and Root Planing: Scaling to remove calculus deposits and root planing to smooth root surfaces	Scaling and root planing used as conventional non-surgical periodontal therapy Non-surgical Scaling and Root Planing: Scaling to remove calculus deposits and root planing to smooth root surfaces
Measure Participants	0	0

6. Secondary Outcome

Title	Patient Reported Outcomes: VAS Questionnaire
Description	Measure patient reported pain (0-100), comfort (0-100), sensitivity (0-100) and satisfaction (0-100) using VAS questionnaire, with lower values indicating better outcome for pain and sensitivity and higher values indicating better outcome for comfort and satisfaction.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

15 participants had a total of 90 sites (periodontal pockets), randomized 45 to Test and 45 to Control interventions. Pilot enrollees were not assessed for outcome measures.

Arm/Group Title	SRP + Adjunctive Laser Therapy	SRP Alone	Pilot Procedure Arm
Arm/Group Description	Laser therapy used as an adjunct to scaling and root planing	Scaling and root planing used as conventional non-surgical periodontal therapy	Preliminary enrollment of individuals to pilot-test the protocol
Measure Participants	15	15	0
Measure Periodontal pocket sites	45	45	0
Pain	2.316 (6.634)	1.056 (3.334)
Comfort	100 (0)	100 (0)
Sensitivity	16.158 (30.848)	20.833 (32.787)
Satisfaction	99.579 (1.853)	99.611 (1.65)

Adverse Events

Time Frame	12 months
Arm/Group Title	SRP + Adjunctive Laser Therapy		SRP Alone		Pilot Procedure Arm
Arm/Group Description	Laser therapy used as an adjunct to scaling and root planing Following patient identification, review of health history and checking vital signs, local anesthesia is applied to the area. Laser Therapy: Adjunctive application of laser therapy to de-epithelialize the outer surface of gingival margin and within the periodontal pocket. The inner pocket epithelium is removed from the free gingival margin to the level equal with the pocket depth. Non-surgical Scaling and Root Planing: Scaling with ultrasonic scaler and hand instruments to remove calculus deposits and root planing to smooth root surfaces. Laser Therapy: Following non-surgical scaling and root planing, laser is used to remove smear layer from root surface, to completely remove pocket lining and to degranulate the pocket. Laser is used to decorticate and stimulate the bone at the base of defect. Finally, the laser is used to remove the residual debris while inducing blood coagulation. The surgical site is compressed with moistened 2 x 2 gauze using finger pressure for several minutes to achieve hemostasis.		Scaling and root planing used as conventional non-surgical periodontal therapy Following patient identification, review of health history and checking vital signs, local anesthesia is applied to the area. Non-surgical Scaling and Root Planing: Scaling with ultrasonic scaler and hand instruments to remove calculus deposits and root planing to smooth root surfaces. Pockets were flushed with ultrasonic scaler.		Preliminary enrollment of individuals to pilot-test the protocol
All Cause Mortality
	SRP + Adjunctive Laser Therapy		SRP Alone		Pilot Procedure Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)		0/5 (0%)
Serious Adverse Events
	SRP + Adjunctive Laser Therapy		SRP Alone		Pilot Procedure Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	SRP + Adjunctive Laser Therapy		SRP Alone		Pilot Procedure Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.