Root Biomodification With Citric Acid and Tetracycline Improves the Outcomes of Root Coverage

NCT ID: NCT02259543

Last Updated: 2014-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-03-31

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).

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

G0

Root decontamination performed by scaling and root planing followed by rinsing with saline solution during the treatment of recession defects by subepithelial connective tissue graft (SCTG). Control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

G90

Root conditioning with citric acid+tetracycline solution (1:1) for 90 seconds after scaling and root planing, followed by rinsing with saline solution for root decontamination during the treatment of recession defects by subepithelial connective tissue graft (SCTG).

Group Type: ACTIVE_COMPARATOR

Root conditioning with citric acid+tetracycline solution

Intervention Type: OTHER

Application of a citric acid + tetracycline gel solution (1:1) for decontamination of root surfaces during the treatment of recession defects by subepithelial connective tissue graft

G180

Root conditioning with citric acid+tetracycline solution (1:1) for 180 seconds after scaling and root planing, followed by rinsing with saline solution for root decontamination during the treatment of recession defects by subepithelial connective tissue graft (SCTG).

Group Type: ACTIVE_COMPARATOR

Root conditioning with citric acid+tetracycline solution

Intervention Type: OTHER

Application of a citric acid + tetracycline gel solution (1:1) for decontamination of root surfaces during the treatment of recession defects by subepithelial connective tissue graft

Interventions

Root conditioning with citric acid+tetracycline solution

Application of a citric acid + tetracycline gel solution (1:1) for decontamination of root surfaces during the treatment of recession defects by subepithelial connective tissue graft

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Adriana Campos Passanezi SantAna

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

João Paulo C Barros, Master

Role: PRINCIPAL_INVESTIGATOR

Graduation student

Locations

School of Dentistry at Bauru- University of São Paulo; Clinics of Periodontics

Bauru, São Paulo, Brazil

Countries

Brazil

Other Identifiers

018/2010

Identifier Type: -

Identifier Source: org_study_id