Clinical trial NCT04027686: Clinical Evaluation of Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Gum Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis Chronic Generalized Moderate
Periodontitis Chronic Generalized Severe
Keywords: Laser Therapy
Non-surgical periodontal therapy
Scaling and root planing
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Biolase Inc
First posted: 2019-07-22
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Controlled, Split-mouth
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Probing Pocket Depth
timeFrame: 12 months
measure: Sites That Bleed on Probing
timeFrame: 12 months
measure: Gingival Recession
timeFrame: 12 months
measure: Clinical Attachment Level
timeFrame: 12 months
Secondary outcomes:
measure: Periodontal Microbiome
timeFrame: 12 months
measure: Patient Reported Outcomes: VAS Questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: UCLA School of Dentistry, Section of Periodontics
name: Perry R Klokkevold, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: