Comparison Between Connective Graft and Xenogeneic Matrix, in Patients With Multiple Gingival Recessions
Primary Purpose
Gingival Recession, Generalized
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Root coverage surgery
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession, Generalized focused on measuring Gingival Recession, Collagen Matrix, Periodontics
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of multiple gingival recessions ≥ 2 mm, only in aesthetic areas (upper central and lateral incisive, and canine);
- Miller class I and II gingival recession areas
- Non-abrasive, erosive or carious root surfaces
- Unrotated, non-extruded and non-movable teeth
- Systemically healthy patients without contraindication to periodontal surgical procedures
Exclusion Criteria:
- Smokers
- Pregnant women and infants
- Patients with a history of periodontal disease or recurrent abscess formation
- Patients previously submitted to surgical procedures for root coverage
- Patients taking anti-convulsant drugs
- Antihypertensives, contraceptives or immunossupressors
- Patients with low oral hygiene (plaque and bleeding index over 20%)
Sites / Locations
- Raphaella C Michel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control SCTG
Test CM
Arm Description
Root coverage surgery with subepithelial connective tissue graft to an extensive treat multiple gingival recessions in aesthetic areas
Root coverage surgery with Mucograft® collagen matrix to treat an extensive multiple gingival recessions in aesthetic areas
Outcomes
Primary Outcome Measures
Gingival recession depth (GRD)
Distance in millimeters from ECJ to gingival margin at three points (mesial, center and distal); Distance from cemento-enamel junction to gingival margin = 0 mm
Secondary Outcome Measures
Keratinized mucosa width
Keratinized mucosa width measured with a periodontal probe in millimeters Ideal if keratinized mucosa width > 5mm
Dentin hypersensitivity
Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale Ideal if scale = 0
Full Information
NCT ID
NCT03207984
First Posted
June 30, 2017
Last Updated
February 27, 2023
Sponsor
University of Sao Paulo
Collaborators
Geistlich Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT03207984
Brief Title
Comparison Between Connective Graft and Xenogeneic Matrix, in Patients With Multiple Gingival Recessions
Official Title
Xenogeneic Collagen Matrix and Connective Tissue Graft Comparison for Multiple Gingival Recessions in Esthetic Areas: A Non-inferiority Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
September 20, 2020 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Geistlich Pharma AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Subepithelial connective tissue graft (SCTG) is considered the gold standard for root coverage treatment. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of MC are very promising, both for root coverage as well as for the gain of keratinized tissue. The present study consists of a parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (upper central incisors, Lateral and canine).
Detailed Description
Obtaining an aesthetic smile is one of the main reasons for the patient's demand for dental treatment, especially when it comes to gingival recession. However, there is a lack of evidence in the literature explaining the most appropriate type of treatment for multiple recessions in aesthetic areas. For unitary gingival recessions, the subepithelial connective tissue graft (SCTG) is considered the gold standard because it presents greater predictability for root coverage. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of CM are very promising, both for root coverage as well as for the gain of keratinized mucosa. The present study will consist of a double-blind parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (central incisors, Lateral, upper canine). All measurements will be evaluated initially and in the periods of 3, 6, and 12 months after the surgical procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Generalized
Keywords
Gingival Recession, Collagen Matrix, Periodontics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control SCTG
Arm Type
Active Comparator
Arm Description
Root coverage surgery with subepithelial connective tissue graft to an extensive treat multiple gingival recessions in aesthetic areas
Arm Title
Test CM
Arm Type
Experimental
Arm Description
Root coverage surgery with Mucograft® collagen matrix to treat an extensive multiple gingival recessions in aesthetic areas
Intervention Type
Procedure
Intervention Name(s)
Root coverage surgery
Intervention Description
Periodontal plastic surgery aiming the treatment of multiple gingival recessions in aesthetics areas with SCTG and CM
Primary Outcome Measure Information:
Title
Gingival recession depth (GRD)
Description
Distance in millimeters from ECJ to gingival margin at three points (mesial, center and distal); Distance from cemento-enamel junction to gingival margin = 0 mm
Time Frame
one year
Secondary Outcome Measure Information:
Title
Keratinized mucosa width
Description
Keratinized mucosa width measured with a periodontal probe in millimeters Ideal if keratinized mucosa width > 5mm
Time Frame
year
Title
Dentin hypersensitivity
Description
Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale Ideal if scale = 0
Time Frame
year
Other Pre-specified Outcome Measures:
Title
Complete root coverage
Description
Assessed in which the gingival margin was at or above the cementoenamel junction (CEJ)
Time Frame
year
Title
Probing Depth (PD)
Description
Distance in millimeters from the gingival margin to the bottom of the gingival sulcus at three points (mesial, center and distal)
Time Frame
year
Title
Clinical attachment level loss (CAL)
Description
Measured in millimeters from the bottom of the periodontal pocket to the cementoenamel junction at three sites per tooth (mesial, center and distal)
Time Frame
year
Title
Soft tissue thickness (STT)
Description
Determined at 2mm apical the gingival margin at the central buccal site with anesthetic needle and endodontic stop and digital pachymeter
Time Frame
year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of multiple gingival recessions ≥ 2 mm, only in aesthetic areas (upper central and lateral incisive, and canine);
Miller class I and II gingival recession areas
Non-abrasive, erosive, or carious root surfaces
Unrotated, non-extruded, and non-movable teeth
Systemically healthy patients without contraindication to periodontal surgical procedures
Exclusion Criteria:
Smokers
Pregnant women and infants
Patients with a history of periodontal disease or recurrent abscess formation
Patients previously submitted to surgical procedures for root coverage
Patients taking anti-convulsant drugs
Antihypertensives, contraceptives or immunosuppressors
Patients with low oral hygiene (plaque and bleeding index over 20%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphaella C Michel, PhD
Organizational Affiliation
University of São Paulo, Bauru School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raphaella C Michel
City
Bauru
State/Province
SP
ZIP/Postal Code
17012-901
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20350159
Citation
McGuire MK, Scheyer ET. Xenogeneic collagen matrix with coronally advanced flap compared to connective tissue with coronally advanced flap for the treatment of dehiscence-type recession defects. J Periodontol. 2010 Aug;81(8):1108-17. doi: 10.1902/jop.2010.090698.
Results Reference
background
PubMed Identifier
21721988
Citation
Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial. J Periodontol. 2012 Mar;83(3):321-8. doi: 10.1902/jop.2011.110215. Epub 2011 Jul 1.
Results Reference
background
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Comparison Between Connective Graft and Xenogeneic Matrix, in Patients With Multiple Gingival Recessions
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