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

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ClinicalTrials.gov Identifier: NCT02259543
Recruitment Status : Completed
First Posted : October 8, 2014
Last Update Posted : October 8, 2014
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Adriana Campos Passanezi SantAna, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Gingival Recession Other: Root conditioning with citric acid+tetracycline solution Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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.
Active Comparator: 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).
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

Active Comparator: 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).
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




Primary Outcome Measures :
  1. percentage of root coverage (%REC) [ Time Frame: one year ]
    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 :
  1. reduction in recession height [ Time Frame: one year ]
    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).

  2. increase in the width of keratinized gingiva [ Time Frame: one year ]
    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).

  3. gain in clinical attachment level [ Time Frame: one year ]
    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).


Other Outcome Measures:
  1. reduction in probing depth [ Time Frame: one year ]
    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).

  2. reduction in bleeding index [ Time Frame: one year ]
    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)

  3. reduction in plaque index [ Time Frame: one year ]
    Difference in the presence (score 1) or absence (score 0) of plaque accumulation, visually determined (index; percentage)



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259543


Locations
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Brazil
School of Dentistry at Bauru- University of São Paulo; Clinics of Periodontics
Bauru, São Paulo, Brazil, 17012-912
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: João Paulo C Barros, Master Graduation student

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Responsible Party: Adriana Campos Passanezi SantAna, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02259543     History of Changes
Other Study ID Numbers: 018/2010
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: October 8, 2014
Last Verified: October 2014
Keywords provided by Adriana Campos Passanezi SantAna, University of Sao Paulo:
gingival recession
soft tissue
root biomodification
root coverage
citric acid
tetracycline
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy
Tetracycline
Sodium Citrate
Citric Acid
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents