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Trial record 18 of 201 for:    TETRACYCLINE

Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Methods

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03095378
Recruitment Status : Completed
First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Carla Andreotti Damante, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE March 23, 2017
First Posted Date  ICMJE March 29, 2017
Last Update Posted Date March 29, 2017
Actual Study Start Date  ICMJE March 10, 2014
Actual Primary Completion Date February 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
Total root coverage measured with a periodontal probe in mm [ Time Frame: one year ]
Distance from cemento-enamel junction to gingival margin = 0 mm
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
  • Keratinized mucosa width measured with a periodontal probe in mm [ Time Frame: one year ]
    Ideal if keratinized mucosa width > 5mm
  • Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale [ Time Frame: one year ]
    Ideal if scale = 0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Methods
Official Title  ICMJE Evaluation of Root Coverage by Subepithelial Connective Graft Associated to Root Conditioning by Citric Acid Plus Tetracycline and Antimicrobial Photodynamic Therapy: A Randomized Clinical Trial
Brief Summary The aim of this study was to evaluate the effect of two root-conditioning agents used in conjunction with subepithelial connective graft technique on root coverage outcomes. One is citric acid plus tetracycline and the other is antimicrobial photodynamic therapy.
Detailed Description

Citric acid plus tetracycline has properties of root surface decontamination, surface demineralization and exposure of collagen fibers.

Antimicrobial photodynamic therapy has been widely used in Periodontics to obtain reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial resistance. Also, it has properties of root demineralization and exposure of collagen fibers. These properties may enhance root coverage in procedures of subepithelial connective graft.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Interventions in different patients
Masking: Single (Outcomes Assessor)
Masking Description:
The outcome assessor did not have access to patient's records
Primary Purpose: Treatment
Condition  ICMJE Gingival Recession
Intervention  ICMJE
  • Procedure: Control
    Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with scaling and root planing
  • Procedure: citric acid plus tetracycline
    Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with citric acid plus tetracycline
  • Procedure: antimicrobial photodynamic therapy
    Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with antimicrobial photodynamic therapy
Study Arms  ICMJE
  • Active Comparator: Control
    Root treatment with scaling and root planing.
    Intervention: Procedure: Control
  • Experimental: Citric acid plus tetracycline
    Root treatment with 50% citric acid plus 10% tetracycline, pH1, passive application for 90s.
    Intervention: Procedure: citric acid plus tetracycline
  • Experimental: Antimicrobial photodynamic therapy
    Antimicrobial photodynamic therapy with toluidine blue O (100ug/ml - 60s pre-irradiation - pH4) and red laser (660nm, 30 milliwatts, 45 joules per square centimeter, sweeping mode, 90s)
    Intervention: Procedure: antimicrobial photodynamic therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2017)
14
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 10, 2017
Actual Primary Completion Date February 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Gingival recession - Miller's class I or II (2 to 5 mm of height) at least in one tooth
  • Indication of root coverage by dentin hypersensitivity or esthetic

Exclusion Criteria:

  • Smokers
  • Pregnancy
  • Systemic medication use that could impair wound healing or surgery procedure
  • Systemic diseases as diabetes, uncontrolled hypertension, coagulation diseases, kidney diseases.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03095378
Other Study ID Numbers  ICMJE BauruSchoolDentistryPDT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carla Andreotti Damante, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Sao Paulo
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP