Back to resultsTreatment of Multiple Gingival Recessions (3DMUCO)
Primary Purpose
Gingival Recession
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Coronally advanced flap (CAF)
Collagen Matrix
Subepithelial connective tissue graft
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring Root coverage, Gingival recession, Plastic surgery, Connective tissue graft, Mucograft
Eligibility Criteria
Inclusion Criteria:
The patients will be included in the study if they fulfill the following inclusion criteria:
- a clinical diagnosis of multiple-recession type defects at maxillary canines and premolars with at least one GR ≥ 3mm in depth;
- areas of Miller's Class I or II GR;
- teeth without root abrasions or caries.
Exclusion Criteria: -
The exclusion criteria used will be as follows:
- patients allergic to collagen
- a history of smoking (within the previous 6 months)
- pregnancy or lactation
- a history of destructive periodontal disease or the formation of recurrent abscesses
- root caries at the site of recession
- previous surgical root coverage procedures
- systemic healing disorders (for example, acquired immunodeficiency syndrome [AIDS], diabetes mellitus or risk factors evaluated by a medical doctor)
- periodontal disease, or poor plaque control (full mouth plaque index > 20%).
The exclusion criteria for teeth will be:
- noncarious cervical lesions (erosion, abfraction etc.)
- any type of previous cervical restoration
- extrusion
- giroversion
- mobility
- a prominent root surface.
Sites / Locations
- University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Collagen Matrix plus coronally advanced flap (CAF)
Subepithelial connective tissue graft plus CAF
Arm Description
A new collagen matrix (Mucograft) associated to coronally advanced flap
Subepithelial connective tissue graft associated to coronally advanced flap
Outcomes
Primary Outcome Measures
Percentage of root coverage (RC)
The primary clinical outcome will be percentage of root coverage (RC) at 12 months
Secondary Outcome Measures
Reductions in recession depth (RRD)
Measured from the cementum-enamel junction (CEJ) up to the highest point of the gingival margin
Complete root coverage of the gingival recessions (CRC)
Recession width (RW) at the cemento-enamel junction
Relative clinical attachment level (RCAL)
Measured from a fixed point (stent) prepared on the acrylic guide up to the base of the gingival sulcus.
Probing depth (PD)
Calculated as RCAL- PD;
keratinized tissue width (KT)
From the free gingival margin to the mucogingival junction.
Gain in thickness of gingival tissue (GT)
With an injection needle and a silicon marker, 2mm below the gingival margin.
Full Information
NCT ID
NCT02818855
First Posted
August 20, 2013
Last Updated
January 31, 2018
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02818855
Brief Title
Treatment of Multiple Gingival Recessions
Acronym
3DMUCO
Official Title
Treatment of Multiple Gingival Recessions With Collagen Matrix Versus Subepithelial Connective Tissue Graft: A Non-inferiority Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Gingival recession (GR) is frequently associated with deterioration in dental esthetics and dental hypersensitivity. Outcomes from recent systematic reviews have demonstrated that when the root is covered and the gain in the width of keratinized tissue (KT) is expected, the use of subepithelial connective tissue grafts (SCTGs) associated with coronally advanced flaps (CAF) appears to be more predictable, and may be considered the gold standard procedure. However, the SCTGs may increase patients' morbidity (e.g., pain). This occurs because of the need for a donor surgical area, which may increase the risk of surgical complications like bleeding, as well as increases post-operative discomfort and the period of the surgical procedure. Another biomaterial, a new collagen matrix (CM) has been used as a substitute for the SCTG. The use of CM was associated with a significant reduction in post-operative morbidity, less post-operative pain and discomfort in the patient, and more esthetic satisfaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Root coverage, Gingival recession, Plastic surgery, Connective tissue graft, Mucograft
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Collagen Matrix plus coronally advanced flap (CAF)
Arm Type
Experimental
Arm Description
A new collagen matrix (Mucograft) associated to coronally advanced flap
Arm Title
Subepithelial connective tissue graft plus CAF
Arm Type
Active Comparator
Arm Description
Subepithelial connective tissue graft associated to coronally advanced flap
Intervention Type
Procedure
Intervention Name(s)
Coronally advanced flap (CAF)
Other Intervention Name(s)
Subepithelial conjunctive tissue grafts, Coronally advanced flaps, Coronally advanced flaps associated with collagen matrix
Intervention Description
The test group will be treated by means of the association of Collagen Matrix + Coronally Advanced Flap. As treatment, the control group will receive the association of a subepithelial Conjunctive Tissue Graft + Coronally Advanced Flap.
The aim of both procedures will be to obtain root coverage. All these procedures will be performed in a standardized manner.
Intervention Type
Drug
Intervention Name(s)
Collagen Matrix
Other Intervention Name(s)
Mucograft
Intervention Description
A new collagen membrane
Intervention Type
Procedure
Intervention Name(s)
Subepithelial connective tissue graft
Other Intervention Name(s)
connective tissue graft
Intervention Description
Connective tissue graft
Primary Outcome Measure Information:
Title
Percentage of root coverage (RC)
Description
The primary clinical outcome will be percentage of root coverage (RC) at 12 months
Time Frame
12-months
Secondary Outcome Measure Information:
Title
Reductions in recession depth (RRD)
Description
Measured from the cementum-enamel junction (CEJ) up to the highest point of the gingival margin
Time Frame
At the baseline, 3-month, 6-month and 12-months
Title
Complete root coverage of the gingival recessions (CRC)
Time Frame
At the baseline, 3-month, 6-month and 12-months
Title
Recession width (RW) at the cemento-enamel junction
Time Frame
At the baseline, 3-month, 6-month and 12-months
Title
Relative clinical attachment level (RCAL)
Description
Measured from a fixed point (stent) prepared on the acrylic guide up to the base of the gingival sulcus.
Time Frame
At the baseline, 3-month, 6-month and 12-months
Title
Probing depth (PD)
Description
Calculated as RCAL- PD;
Time Frame
At the baseline, 3-month, 6-month and 12-months
Title
keratinized tissue width (KT)
Description
From the free gingival margin to the mucogingival junction.
Time Frame
At the baseline, 3-month, 6-month and 12-months
Title
Gain in thickness of gingival tissue (GT)
Description
With an injection needle and a silicon marker, 2mm below the gingival margin.
Time Frame
At the baseline, 3-month, 6-month and 12-months
Other Pre-specified Outcome Measures:
Title
Subject esthetic satisfaction by participants
Description
The participants will be invited to reply to a questionnaire on subject esthetic satisfaction with the surgical results (from dissatisfied to very satisfied) on a scale of 1-5, as well as after 1, 3, 6 months and after 12 months.
Time Frame
1, 3, 6 months and after 12 months
Title
Subjective symptoms of pain and discomfort by participants
Description
Subjective symptoms of pain and discomfort (without pain and with a great deal of pain) will be evaluated with 10 cm (0-10) visual analog scales (VAS) at 1, 2, 3-week, 1 month, 3-month, 6-month and12-months.
Time Frame
At 1, 2, 3-week, 1 month, 3-month, 6-month and12-months.
Title
Esthetic questionnaire by experienced periodontist
Description
One experienced periodontist will be invited to observe the initial photographs and those of the clinical results obtained during the entire healing process and asked to respond to an esthetic questionnaire (from dissatisfied to very satisfied) on a scale of 1 to 5 points after 1, 2, 3-week, 1-month, 3-month, 6-month and 12-months.12 All this examinations also will be performed in the clinic.
Time Frame
1, 2, 3-week, 1-month, 3-month, 6-month and 12-months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The patients will be included in the study if they fulfill the following inclusion criteria:
a clinical diagnosis of multiple-recession type defects at maxillary canines and premolars with at least one GR ≥ 3mm in depth;
areas of Miller's Class I or II GR;
teeth without root abrasions or caries.
Exclusion Criteria: -
The exclusion criteria used will be as follows:
patients allergic to collagen
a history of smoking (within the previous 6 months)
pregnancy or lactation
a history of destructive periodontal disease or the formation of recurrent abscesses
root caries at the site of recession
previous surgical root coverage procedures
systemic healing disorders (for example, acquired immunodeficiency syndrome [AIDS], diabetes mellitus or risk factors evaluated by a medical doctor)
periodontal disease, or poor plaque control (full mouth plaque index > 20%).
The exclusion criteria for teeth will be:
noncarious cervical lesions (erosion, abfraction etc.)
any type of previous cervical restoration
extrusion
giroversion
mobility
a prominent root surface.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Romito, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
ZIP/Postal Code
05508-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23050490
Citation
Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10.
Results Reference
result
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
result
PubMed Identifier
19678861
Citation
Sanz M, Lorenzo R, Aranda JJ, Martin C, Orsini M. Clinical evaluation of a new collagen matrix (Mucograft prototype) to enhance the width of keratinized tissue in patients with fixed prosthetic restorations: a randomized prospective clinical trial. J Clin Periodontol. 2009 Oct;36(10):868-76. doi: 10.1111/j.1600-051X.2009.01460.x. Epub 2009 Aug 12.
Results Reference
result
Learn more about this trial
Treatment of Multiple Gingival Recessions
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