Clinical trial NCT02259543: Root Biomodification With Citric Acid and Tetracycline Improves the Outcomes of Root Coverage
Official title: Conditioning of Root Surfaces With Citric Acid and Tetracycline for Different Application Times Improves the Outcomes of Root Coverage by Subepithelial Connective Tissue Graft: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: gingival recession
soft tissue
root biomodification
root coverage
citric acid
tetracycline
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-10-08
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of the application of a citric acid + tetracycline gel solution during 90 or 180 seconds compared to no conditioning in the outcomes of treatment of Miller's class I or II recession defects by subepithelial connective tissue graft.

Detailed description: Adult patients showing Miller's class I or II recession defects requiring root coverage were recruited to participate in the study. All patients were submitted to non surgical periodontal therapy consisting of scaling and root planing, prophylaxis, and oral hygiene instruction in order to reduce/eliminate gingival inflammation. After that, patients were randomly allocated to three different treatment groups based on root conditioning: G0- no conditioning; G90- root conditioning for 90 seconds; G180- root conditioning for 180 seconds. Allocation was defined by a software. Root coverage was performed by subepithelial connective tissue graft (SCTG) in all treated sites by the same operator, who performed the indicated root treatment. Periodontal parameters were investigated at baseline and at 1, 3, 6 and 12 months post-operatively by a blinded trained expertise different from operator and included: pocket depth, recession height, clinical attachment level, width of keratinized gingiva, sulcular bleeding index and plaque index. Hypersensitivity at recession sites was also investigated at baseline and at 7 days, 14 days, 1, 3, 6 and 12 months after treatment according to visual analogic scale (VAS).

Eligibility criteria: Inclusion Criteria:

* presence of Miller's class I or II recession extending 2-5 mm apical to CEJ requiring root coverage for the following reasons: esthetics, progression of recession or hypersensitivity.

Exclusion Criteria:

* smokers;
* pregnants;
* routine use of anti-convulsants, anti-hypertensive or cyclosporine;
* uncontrolled systemic diseases (e.g.: diabetes mellitus);
* systemic conditions that requires antibiotic prophylaxis (e.g.: history of bacterial endocarditis; rheumatoid arthritis; prosthetic valves);
* antibiotics, steroidal or non-steroidal anti-inflammatory intake in the 6-month previous period.

Primary outcomes:
measure: percentage of root coverage (%REC)
timeFrame: one year
Secondary outcomes:
measure: reduction in recession height
timeFrame: one year
measure: increase in the width of keratinized gingiva
timeFrame: one year
measure: gain in clinical attachment level
timeFrame: one year
Other outcomes:
measure: reduction in probing depth
timeFrame: one year
measure: reduction in bleeding index
timeFrame: one year
measure: reduction in plaque index
timeFrame: one year
Locations:
city: Bauru
country: Brazil
facility: School of Dentistry at Bauru- University of São Paulo; Clinics of Periodontics
state: São Paulo
Study officials:
affiliation: Graduation student
name: João Paulo C Barros, Master
role: PRINCIPAL_INVESTIGATOR
References: