Trial Outcomes & Findings for Clinical Evaluation of Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Gum Disease (NCT NCT04027686)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

12 months

Results posted on

2021-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Periodontal Sites Assigned to SRP or SRP + Adjunctive Laser Therapy 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	Pilot Procedure Arm Preliminary enrollment of individuals to pilot-test the protocol
Overall Study STARTED	17	6
Overall Study COMPLETED	15	5
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Periodontal Sites Assigned to SRP or SRP + Adjunctive Laser Therapy 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	Pilot Procedure Arm Preliminary enrollment of individuals to pilot-test the protocol
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Each participant was treated with both SRP + Adjunctive Laser Therapy (test) and SRP alone (control) in separate quadrants. Thus, the total number of participants is the same number observed in each group. Subjects served as their own control.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Periodontal Sites Assigned to SRP + Adjunctive Laser Therapy or SRP Alone n=17 Participants 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.	Pilot Procedure Arm n=6 Participants Preliminary enrollment of individuals to pilot-test the protocol	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=17 Participants • Each participant was treated with both SRP + Adjunctive Laser Therapy (test) and SRP alone (control) in separate quadrants. Thus, the total number of participants is the same number observed in each group. Subjects served as their own control.	0 Participants n=6 Participants • Each participant was treated with both SRP + Adjunctive Laser Therapy (test) and SRP alone (control) in separate quadrants. Thus, the total number of participants is the same number observed in each group. Subjects served as their own control.	0 Participants n=23 Participants • Each participant was treated with both SRP + Adjunctive Laser Therapy (test) and SRP alone (control) in separate quadrants. Thus, the total number of participants is the same number observed in each group. Subjects served as their own control.
Age, Categorical Between 18 and 65 years	16 Participants n=17 Participants • Each participant was treated with both SRP + Adjunctive Laser Therapy (test) and SRP alone (control) in separate quadrants. Thus, the total number of participants is the same number observed in each group. Subjects served as their own control.	6 Participants n=6 Participants • Each participant was treated with both SRP + Adjunctive Laser Therapy (test) and SRP alone (control) in separate quadrants. Thus, the total number of participants is the same number observed in each group. Subjects served as their own control.	22 Participants n=23 Participants • Each participant was treated with both SRP + Adjunctive Laser Therapy (test) and SRP alone (control) in separate quadrants. Thus, the total number of participants is the same number observed in each group. Subjects served as their own control.
Age, Categorical >=65 years	1 Participants n=17 Participants • Each participant was treated with both SRP + Adjunctive Laser Therapy (test) and SRP alone (control) in separate quadrants. Thus, the total number of participants is the same number observed in each group. Subjects served as their own control.	0 Participants n=6 Participants • Each participant was treated with both SRP + Adjunctive Laser Therapy (test) and SRP alone (control) in separate quadrants. Thus, the total number of participants is the same number observed in each group. Subjects served as their own control.	1 Participants n=23 Participants • Each participant was treated with both SRP + Adjunctive Laser Therapy (test) and SRP alone (control) in separate quadrants. Thus, the total number of participants is the same number observed in each group. Subjects served as their own control.
Sex: Female, Male Female	12 Participants n=17 Participants	2 Participants n=6 Participants	14 Participants n=23 Participants
Sex: Female, Male Male	5 Participants n=17 Participants	4 Participants n=6 Participants	9 Participants n=23 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	17 participants n=17 Participants	6 participants n=6 Participants	17 participants n=23 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 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.

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

Outcome measures

Outcome measures
Measure	SRP + Adjunctive Laser Therapy n=78 Periodontal pockets Laser therapy used as an adjunct to scaling and root planing	SRP Alone n=77 Periodontal pockets Scaling and root planing used as conventional non-surgical periodontal therapy	Pilot Procedure Arm Preliminary enrollment of individuals to pilot-test the protocol
Probing Pocket Depth	4.167 mm Standard Deviation 0.986	4.273 mm Standard Deviation 1.232	—

PRIMARY outcome

Timeframe: 12 months

Population: 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.

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

Outcome measures

Outcome measures
Measure	SRP + Adjunctive Laser Therapy n=78 Periodontal pockets Laser therapy used as an adjunct to scaling and root planing	SRP Alone n=77 Periodontal pockets Scaling and root planing used as conventional non-surgical periodontal therapy	Pilot Procedure Arm Preliminary enrollment of individuals to pilot-test the protocol
Sites That Bleed on Probing	55.1 percentage of sites with bleeding	63.6 percentage of sites with bleeding	—

PRIMARY outcome

Timeframe: 12 months

Population: 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.

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

Outcome measures

Outcome measures
Measure	SRP + Adjunctive Laser Therapy n=78 Periodontal pockets Laser therapy used as an adjunct to scaling and root planing	SRP Alone n=77 Periodontal pockets Scaling and root planing used as conventional non-surgical periodontal therapy	Pilot Procedure Arm Preliminary enrollment of individuals to pilot-test the protocol
Gingival Recession	1.167 mm Standard Deviation 1.263	1.182 mm Standard Deviation 1.305	—

PRIMARY outcome

Timeframe: 12 months

Population: 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.

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

Outcome measures

Outcome measures
Measure	SRP + Adjunctive Laser Therapy n=78 Periodontal pockets Laser therapy used as an adjunct to scaling and root planing	SRP Alone n=77 Periodontal pockets Scaling and root planing used as conventional non-surgical periodontal therapy	Pilot Procedure Arm Preliminary enrollment of individuals to pilot-test the protocol
Clinical Attachment Level	5.346 mm Standard Deviation 1.578	5.455 mm Standard Deviation 1.766	—

SECONDARY outcome

Timeframe: 12 months

Population: Microbiome results will not be available for analysis until April 2021

Assess changes in periodontal microbiome using DNA sequencing

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SRP + Adjunctive Laser Therapy n=45 Periodontal pocket sites Laser therapy used as an adjunct to scaling and root planing	SRP Alone n=45 Periodontal pocket sites Scaling and root planing used as conventional non-surgical periodontal therapy	Pilot Procedure Arm Preliminary enrollment of individuals to pilot-test the protocol
Patient Reported Outcomes: VAS Questionnaire Pain	2.316 units on a scale Standard Deviation 6.634	1.056 units on a scale Standard Deviation 3.334	—
Patient Reported Outcomes: VAS Questionnaire Comfort	100 units on a scale Standard Deviation 0	100 units on a scale Standard Deviation 0	—
Patient Reported Outcomes: VAS Questionnaire Sensitivity	16.158 units on a scale Standard Deviation 30.848	20.833 units on a scale Standard Deviation 32.787	—
Patient Reported Outcomes: VAS Questionnaire Satisfaction	99.579 units on a scale Standard Deviation 1.853	99.611 units on a scale Standard Deviation 1.65	—

Adverse Events

SRP + Adjunctive Laser Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SRP Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pilot Procedure Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Perry Klokkevold

UCLA Periodontics and Implant Surgery

Phone: 3108251927

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place