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

Not Applicable

Completed

• Conditions: Periodontitis Chronic Generalized Severe; Periodontitis Chronic Generalized Moderate
• Interventions: Procedure: Non-surgical Scaling and Root Planing; Device: Laser Therapy

• Registration Number: NCT04027686
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-22
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Results First Submitted: 2021-01-26
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-12
• Last Update Submitted: 2021-02-12
• Results First Posted: 2021-03-05
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SRP alone	Non-surgical Scaling and Root Planing	Scaling and root planing used as conventional non-surgical periodontal therapy
SRP + Adjunctive Laser Therapy	Laser Therapy	Laser therapy used as an adjunct to scaling and root planing
SRP + Adjunctive Laser Therapy	Non-surgical Scaling and Root Planing	Laser therapy used as an adjunct to scaling and root planing

Primary Outcome Measures

Name	Time	Method
Probing Pocket Depth	12 months	This is a measure from base of pocket to gingival margin.
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.
Gingival Recession	12 months	Measure of gingival recession following treatment. This is a measure of the gingival margin from the cement-enamel junction.
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

Name	Time	Method
Periodontal Microbiome	12 months	Assess changes in periodontal microbiome using DNA sequencing
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.