Clinical trial NCT03095378: Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Methods
Official title: Evaluation of Root Coverage by Subepithelial Connective Graft Associated to Root Conditioning by Citric Acid Plus Tetracycline and Antimicrobial Photodynamic Therapy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: gingival recession
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventions in different patients
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the effect of two root-conditioning agents used in conjunction with subepithelial connective graft technique on root coverage outcomes. One is citric acid plus tetracycline and the other is antimicrobial photodynamic therapy.

Detailed description: Citric acid plus tetracycline has properties of root surface decontamination, surface demineralization and exposure of collagen fibers.

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.

Eligibility criteria: Inclusion Criteria:

* Gingival recession - Miller's class I or II (2 to 5 mm of height) at least in one tooth
* Indication of root coverage by dentin hypersensitivity or esthetic

Exclusion Criteria:

* Smokers
* Pregnancy
* Systemic medication use that could impair wound healing or surgery procedure
* Systemic diseases as diabetes, uncontrolled hypertension, coagulation diseases, kidney diseases.

Primary outcomes:
measure: Total root coverage measured with a periodontal probe in mm
timeFrame: one year
Secondary outcomes:
measure: Keratinized mucosa width measured with a periodontal probe in mm
timeFrame: one year
measure: Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale
timeFrame: one year
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru School of Dentistry
state: Sao Paulo
Study officials:
References:
citation: Damante CA, Ducati P, Ferreira R, Salmeron S, Zangrando MSR, de Rezende MLR, Sant'Ana ACP, Greghi SLA, Magalhaes AC. In vitro evaluation of adhesion/proliferation of human gingival fibroblasts on demineralized root surfaces by toluidine blue O in antimicrobial photodynamic therapy. Photodiagnosis Photodyn Ther. 2016 Mar;13:303-307. doi: 10.1016/j.pdpdt.2015.08.009. Epub 2015 Sep 7.
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.