Root Biomodification With Citric Acid and Tetracycline Improves the Outcomes of Root Coverage
Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gingival Recession
Intervention: Root conditioning with citric acid+tetracycline solution (Other)
Phase: N/A
Status: Completed
Sponsored by: University of Sao Paulo Official(s) and/or principal investigator(s): João Paulo C Barros, Master, Principal Investigator, Affiliation: Graduation student
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: percentage of root coverage (%REC)
Secondary outcome: reduction in recession heightincrease in the width of keratinized gingiva gain in clinical attachment level
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
Minimum age: 20 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
School of Dentistry at Bauru- University of São Paulo; Clinics of Periodontics, Bauru, São Paulo 17012-912, Brazil
Additional Information
Starting date: August 2011
Last updated: October 5, 2014
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