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

NCT04027686 | Completed Results FDA Device

• 1 other identifier: IRB#15-000519
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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

Keywords

Laser Therapy; Non-surgical periodontal therapy; Scaling and root planing

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Periodontal Microbiome

  12 months

• Patient Reported Outcomes: VAS Questionnaire

  12 months

Study Arms (2)

SRP + Adjunctive Laser Therapy

EXPERIMENTAL

Laser therapy used as an adjunct to scaling and root planing

Device: Laser Therapy; Procedure: Non-surgical Scaling and Root Planing

SRP alone

ACTIVE COMPARATOR

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

Procedure: Non-surgical Scaling and Root Planing

Interventions

Laser Therapy DEVICE

Adjunctive application of laser therapy in the periodontal pocket

SRP + Adjunctive Laser Therapy

Non-surgical Scaling and Root Planing PROCEDURE

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

SRP + Adjunctive Laser Therapy; SRP alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Biolase Inc: collaborator

MeSH Terms

Interventions

Laser Therapy; Root Planing

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Results Point of Contact

• Title: Dr Perry Klokkevold
• Organization: UCLA Periodontics and Implant Surgery

pklokkevold@dentistry.ucla.edu

3108251927

Study Officials

• Perry R Klokkevold, DDS, MS

  UCLA School of Dentistry, Section of Periodontics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Dentistry

Model Details: Randomized, Controlled, Split-mouth

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 22, 2019
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 5, 2021
• Results First Posted: March 5, 2021

Record last verified: 2021-02