Clinical Comparison Between Two Surgical Techniques for the Treatment of Gingival Recessions
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Periodontal surgery to gingival recessions
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring gingival recession, acellular dermal matrix graft, root coverage
Eligibility Criteria
Inclusion Criteria:
- Recession defects are Miller's class I or II and do not vary more or equal than 3 mm
- Main complaint aesthetic issues or dentine hypersensitivity
- The patient must be a candidate for bilateral root coverage procedure
- Patient shows sufficient plaque control (FMPS < 20%)
- The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
- The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent
Exclusion Criteria:
- Smokers
- Systemic diseases
- Pregnants or lactating
- Periodontal disease
- General contraindications for dental and/or surgical treatment are present
- The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
- The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
Sites / Locations
- Faculty of Dentistry of Ribeirão Preto USP
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
test and control
Arm Description
The test and control technique will be tested in a split-mouth design.
Outcomes
Primary Outcome Measures
Percentage of root coverage
Clinical parameters will be assessed after 6 months of surgical procedures.
Secondary Outcome Measures
Keratinized Tissue
Clinical parameters will be assessed after 6 months of surgical procedures.
Full Information
NCT ID
NCT01175720
First Posted
August 3, 2010
Last Updated
November 11, 2011
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01175720
Brief Title
Clinical Comparison Between Two Surgical Techniques for the Treatment of Gingival Recessions
Official Title
Clinical Comparison Between Two Surgical Techniques With Acellular Dermal Matrix Graft in the Treatment of Gingival Recessions
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
October 2011 (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
No
5. Study Description
Brief Summary
The aim of this study is to test a surgical technique for the treatment of gingival recessions. The hypothesis of the study is to promote greater root coverage and better healing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
gingival recession, acellular dermal matrix graft, root coverage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
test and control
Arm Type
Experimental
Arm Description
The test and control technique will be tested in a split-mouth design.
Intervention Type
Procedure
Intervention Name(s)
Periodontal surgery to gingival recessions
Intervention Description
Test and control technique to treat gingival recessions.
Primary Outcome Measure Information:
Title
Percentage of root coverage
Description
Clinical parameters will be assessed after 6 months of surgical procedures.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Keratinized Tissue
Description
Clinical parameters will be assessed after 6 months of surgical procedures.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Recession defects are Miller's class I or II and do not vary more or equal than 3 mm
Main complaint aesthetic issues or dentine hypersensitivity
The patient must be a candidate for bilateral root coverage procedure
Patient shows sufficient plaque control (FMPS < 20%)
The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent
Exclusion Criteria:
Smokers
Systemic diseases
Pregnants or lactating
Periodontal disease
General contraindications for dental and/or surgical treatment are present
The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur B. Novaes Júnior, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lauro G. Ayub, MSD student
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry of Ribeirão Preto USP
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14040-904
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
22712624
Citation
Ayub LG, Ramos UD, Reino DM, Grisi MF, Taba M Jr, Souza SL, Palioto DB, Novaes AB Jr. A Randomized comparative clinical study of two surgical procedures to improve root coverage with the acellular dermal matrix graft. J Clin Periodontol. 2012 Sep;39(9):871-8. doi: 10.1111/j.1600-051X.2012.01915.x. Epub 2012 Jun 19.
Results Reference
derived
Learn more about this trial
Clinical Comparison Between Two Surgical Techniques for the Treatment of Gingival Recessions
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