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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis Chronic Generalized Moderate; Periodontitis Chronic Generalized Severe
• Intervention / Treatment: Device: Laser Therapy; Procedure: Non-surgical Scaling and Root Planing

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Pocket Depth	This is a measure from base of pocket to gingival margin.	12 months
Sites That Bleed on Probing	Percentage of sites that bleed in response to probing. Bleeding observed within 30 seconds from pocket/sulcus following periodontal probe measurement.	12 months
Gingival Recession	Measure of gingival recession following treatment. This is a measure of the gingival margin from the cement-enamel junction.	12 months
Clinical Attachment Level	Periodontal clinical attachment level following treatment. This is a calculation (clinical attachment level = probing pocket depth + gingival recession).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal Microbiome	Assess changes in periodontal microbiome using DNA sequencing	12 months
Patient Reported Outcomes: VAS Questionnaire	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.	12 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Biolase Inc
• Investigators: Principal Investigator: Perry R Klokkevold, DDS, MS, UCLA School of Dentistry, Section of Periodontics

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Scaling and root planing; Laser Therapy; Non-surgical periodontal therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: IRB#15-000519

Drug and device information, study documents

• 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