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

Gingival Recession Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259543
• Other study ID #: 018/2010
• Status: Completed
• Phase: N/A
• First received: September 28, 2014
• Last updated: October 5, 2014
• Start date: August 2011
• Est. completion date: March 2013

Study information

• Verified date: October 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Other:
• 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

Locations

Country	Name	City	State
Brazil	School of Dentistry at Bauru- University of São Paulo; Clinics of Periodontics	Bauru	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	reduction in probing depth	Linear difference of final and baseline probing pocket measurements. Measured with a millimeter periodontal probe as the distance between gingival margin and the bottom of the sulcus or pocket (in mm).	one year	No
Other	reduction in bleeding index	Difference in the presence (score 1) or absence (0) of bleeding on probing, up to 10 seconds after removal of the probe from the sulcus (index; percentage)	one year	No
Other	reduction in plaque index	Difference in the presence (score 1) or absence (score 0) of plaque accumulation, visually determined (index; percentage)	one year	No
Primary	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	No
Secondary	reduction in recession height	Linear difference between final recession height and baseline recession height, measured by a millimeter periodontal probe as the distance from cementum-enamel junction and gingival margin at the center of recession defect (in mm).	one year	No
Secondary	increase in the width of keratinized gingiva	Linear difference between final and baseline width of keratinized gingiva. Measured with a millimeter periodontal problem as the distance from gingival margin to mucogingival junction (in mm).	one year	No
Secondary	gain in clinical attachment level	Linear difference between final and baseline clinical attachment level. Measured with a millimeter periodontal probe as the distance from cementum-enamel junction and the bottom of the sulcus or pocket (in mm).	one year	No