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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04027686
Other study ID # IRB#15-000519
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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