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

NCT02259543 | Completed DMC

• 1 other identifier: 018/2010
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Keywords

gingival recession; soft tissue; root biomodification; root coverage; citric acid; tetracycline

Outcome Measures

Primary Outcomes (1)

• percentage of root coverage (%REC)

  Percentage of root coverage obtained at 1 year after procedure. Represented by the difference of baseline recession height and final recession height divided by baseline recession height multiplied by 100 (in percentage).

  one year

Secondary Outcomes (3)

• reduction in recession height

  one year

• increase in the width of keratinized gingiva

  one year

• gain in clinical attachment level

  one year

Other Outcomes (3)

• reduction in probing depth

  one year

• reduction in bleeding index

  one year

• reduction in plaque index

  one year

Study Arms (3)

G0

NO INTERVENTION

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.

G90

ACTIVE COMPARATOR

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).

Other: Root conditioning with citric acid+tetracycline solution

G180

ACTIVE COMPARATOR

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).

Other: Root conditioning with citric acid+tetracycline solution

Interventions

Root conditioning with citric acid+tetracycline solution 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; G90

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

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

Bauru, São Paulo, 17012-912, Brazil

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• João Paulo C Barros, Master

  Graduation student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 28, 2014
• First Posted: October 8, 2014
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: October 8, 2014

Record last verified: 2014-10

Locations

BR (1)