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

Periodontitis Chronic Generalized Severe Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04027686
• Other study ID #: IRB#15-000519
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: February 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis
• Periodontitis Chronic Generalized Moderate
• Periodontitis Chronic Generalized Severe

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Biolase Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing Pocket Depth	This is a measure from base of pocket to gingival margin.	12 months
Primary	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
Primary	Gingival Recession	Measure of gingival recession following treatment. This is a measure of the gingival margin from the cement-enamel junction.	12 months
Primary	Clinical Attachment Level	Periodontal clinical attachment level following treatment. This is a calculation (clinical attachment level = probing pocket depth + gingival recession).	12 months
Secondary	Periodontal Microbiome	Assess changes in periodontal microbiome using DNA sequencing	12 months
Secondary	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