Clinical trial NCT03462368: Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Adjunctive Therapies
Official title: Effects of Photobiomodulation and Antimicrobial Photodynamic Therapy Associated With Subepithelial Connective Tissue Graft on the Root Coverage of Multiple Gingival Recessions: A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Gingival Recession, Generalized
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the effect of two different treatment agents used in conjunction with subepithelial connective graft technique on root coverage outcomes in multiple recession defects. Half of patients will receive root treatment with antimicrobial photodynamic therapy and the other half will receive photobiomodulation therapy by laser on surgery site.

Detailed description: Antimicrobial photodynamic therapy has been widely used in Periodontics to obtain reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial resistance. Also, it has properties of root demineralization and exposure of collagen fibers. These properties may enhance root coverage in procedures of subepithelial connective graft. Laser photobiomodulation has the potential to increase healing and repair, this can generate gains in the root coverage and dental hypersensitivity.

Eligibility criteria: Inclusion Criteria:

* Multiple Gingival recession - two or more Miller's class I or II (2 to 5 mm of height)
* Indication of root coverage by dentin hypersensitivity or esthetic.
* Minimum palate thickness (1,5mm)
* Visible Enamel cement junction (JCE) on the teeth to be treated and pulp vitality
* Patients without signs of periodontal disease activity and with plaque index and bleeding on probing throughout ≤20%;

Exclusion Criteria:

* Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based contraceptives, steroids)
* Smokers
* Pregnancy
* Diabetics
* History of head and neck radiotherapy
* Teeth with mobility
* Malpositioned teeth
* History of periodontal surgery at the area on the last 12 months
* Patients with orthodontic therapy in progression

Primary outcomes:
measure: Total root coverage
timeFrame: One year
Secondary outcomes:
measure: Keratinized mucosa width
timeFrame: One year
measure: Probing depth
timeFrame: One year
measure: Clinical attachment level
timeFrame: One year
measure: Dentin hypersensitivity
timeFrame: One year
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru School of Dentistry
state: Sao Paulo
Study officials:
References:
citation: Karam PS, Sant'Ana AC, de Rezende ML, Greghi SL, Damante CA, Zangrando MS. Root surface modifiers and subepithelial connective tissue graft for treatment of gingival recessions: a systematic review. J Periodontal Res. 2016 Apr;51(2):175-85. doi: 10.1111/jre.12296. Epub 2015 Jun 11.
citation: Fernandes-Dias SB, de Marco AC, Santamaria M Jr, Kerbauy WD, Jardini MA, Santamaria MP. Connective tissue graft associated or not with low laser therapy to treat gingival recession: randomized clinical trial. J Clin Periodontol. 2015 Jan;42(1):54-61. doi: 10.1111/jcpe.12328. Epub 2014 Dec 17.
citation: Anders JJ, Lanzafame RJ, Arany PR. Low-level light/laser therapy versus photobiomodulation therapy. Photomed Laser Surg. 2015 Apr;33(4):183-4. doi: 10.1089/pho.2015.9848. No abstract available.