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

NCT ID: NCT04027686

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-12-31

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.

Conditions

Periodontitis Chronic Generalized Moderate; Periodontitis Chronic Generalized Severe

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SRP + Adjunctive Laser Therapy

Laser therapy used as an adjunct to scaling and root planing

Group Type: EXPERIMENTAL

Laser Therapy

Intervention Type: DEVICE

Adjunctive application of laser therapy in the periodontal pocket

Non-surgical Scaling and Root Planing

Intervention Type: PROCEDURE

Scaling to remove calculus deposits and root planing to smooth root surfaces

SRP alone

Scaling and root planing used as conventional non-surgical periodontal therapy

Group Type: ACTIVE_COMPARATOR

Non-surgical Scaling and Root Planing

Intervention Type: PROCEDURE

Scaling to remove calculus deposits and root planing to smooth root surfaces

Interventions

Laser Therapy

Adjunctive application of laser therapy in the periodontal pocket

Intervention Type: DEVICE

Non-surgical Scaling and Root Planing

Scaling to remove calculus deposits and root planing to smooth root surfaces

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biolase Inc

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Perry R Klokkevold, DDS, MS

Professor of Clinical Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Perry R Klokkevold, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

UCLA School of Dentistry, Section of Periodontics

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB#15-000519

Identifier Type: -

Identifier Source: org_study_id