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

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Root conditioning with citric acid+tetracycline solution
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring gingival recession, soft tissue, root biomodification, root coverage, citric acid, tetracycline

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

G0

G90

G180

Arm Description

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.

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).

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
September 28, 2014
Last Updated
October 5, 2014
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02259543
Brief Title
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

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
gingival recession, soft tissue, root biomodification, root coverage, citric acid, tetracycline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G0
Arm Type
No Intervention
Arm Description
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.
Arm Title
G90
Arm Type
Active Comparator
Arm Description
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).
Arm Title
G180
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Root conditioning with citric acid+tetracycline solution
Intervention Description
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
Primary Outcome Measure Information:
Title
percentage of root coverage (%REC)
Description
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).
Time Frame
one year
Secondary Outcome Measure Information:
Title
reduction in recession height
Description
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).
Time Frame
one year
Title
increase in the width of keratinized gingiva
Description
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).
Time Frame
one year
Title
gain in clinical attachment level
Description
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).
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
reduction in probing depth
Description
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).
Time Frame
one year
Title
reduction in bleeding index
Description
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)
Time Frame
one year
Title
reduction in plaque index
Description
Difference in the presence (score 1) or absence (score 0) of plaque accumulation, visually determined (index; percentage)
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João Paulo C Barros, Master
Organizational Affiliation
Graduation student
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry at Bauru- University of São Paulo; Clinics of Periodontics
City
Bauru
State/Province
São Paulo
ZIP/Postal Code
17012-912
Country
Brazil

12. IPD Sharing Statement

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

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