Back to resultsTreatment of Single Maxillary Gingival Recession With Loss of Inter-dental Attachment. A Randomized Controlled Clinical Trial
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
CAF+CTG
CAF
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
Eligibility Criteria
Inclusion Criteria:
- Smoking < 20 cigarettes/day.
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 15% (measured at four sites per tooth).
- Presence of at least one RT2 (Cairo et al. 2011) buccal gingival recession > 2 mm of depth
- Only gingival recessions localized at upper central and lateral incisors, canine, and first and second pre-molars associated with aesthetic problems and/ordental hypersensitivity were considered.
- Presence of an identifiable CEJ
Exclusion Criteria:
- Systemic diseases or pregnancy.
- Systemic antibiotic therapy in the last 6 months.
- Active periodontal disease with sites showing probing depth >4 mm.
Sites / Locations
- University of Florence
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CAF+CTG
CAF
Arm Description
After local anaesthesia, a split-full-split thickness flap was elevated. The papillae adjacent to the involved tooth were then de-epithelialized. A gentle root debridement was performed. A 1-2-mm-thick CTG was harvested using a single incision approach from the palate in the area between the second pre-molar and the second molar. The wound on the donor site of the palate was then sutured. The graft was positioned on the instrumented root surface immediately apical or at the level of the CEJ and then stabilized using a compressive crossing suture, anchored to the periosteum apical to the graft and closed with a palatal knot. The flap was coronally displaced 1-2 mm above the CEJ and sutured
After local anaesthesia, a split-full-split thickness flap was elevated. The papillae adjacent to the involved tooth were then de-epithelialized. A gentle root debridement was performed. The flap was coronally displaced 1-2 mm above the CEJ and sutured
Outcomes
Primary Outcome Measures
Complete Root Coverage (CRC)
Complete Root Coverage: absence of gingival recession (Yes/No)
Secondary Outcome Measures
Recession Reduction (RecRed)
Change of the gingival recession, in mm
Root Coverage Aesthetic Score (RES)
A scoring system ranging from 0 to 10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05460182
Brief Title
Treatment of Single Maxillary Gingival Recession With Loss of Inter-dental Attachment. A Randomized Controlled Clinical Trial
Official Title
Coronally Advanced Flap With and Without Connective Tissue Graft for the Treatment of Single Maxillary Gingival Recession With Loss of Inter-dental Attachment. A Randomized Controlled Clinical Trial - 10 Years Results
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Florence
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: The aim of this randomized clinical trial (RCT) was to evaluate the adjunctive benefit of Connective Tissue Graft (CTG) to Coronally Advanced Flap (CAF) for the treatment of gingival recession associated with inter-dental clinical attachment loss equal or smaller to the buccal attachment loss (RT2). Material and Methods:The patients were randomly assigned to CAF+CTG (test group) or to CAF alone (Control group). Measurements were performed by a blind and calibrated examiner. Outcome measures included complete root coverage (CRC), recession reduction (RecRed), Root coverage Esthetic Score (RES), intra-operative and post-operative morbidity, and root sensitivity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Two examiners, blinded with respect to the surgical procedures, assessed all the clinical and aesthetic outcomes of treatments.
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAF+CTG
Arm Type
Experimental
Arm Description
After local anaesthesia, a split-full-split thickness flap was elevated. The papillae adjacent to the involved tooth were then de-epithelialized. A gentle root debridement was performed.
A 1-2-mm-thick CTG was harvested using a single incision approach from the palate in the area between the second pre-molar and the second molar. The wound on the donor site of the palate was then sutured. The graft was positioned on the instrumented root surface immediately apical or at the level of the CEJ and then stabilized using a compressive crossing suture, anchored to the periosteum apical to the graft and closed with a palatal knot. The flap was coronally displaced 1-2 mm above the CEJ and sutured
Arm Title
CAF
Arm Type
Active Comparator
Arm Description
After local anaesthesia, a split-full-split thickness flap was elevated. The papillae adjacent to the involved tooth were then de-epithelialized. A gentle root debridement was performed. The flap was coronally displaced 1-2 mm above the CEJ and sutured
Intervention Type
Other
Intervention Name(s)
CAF+CTG
Intervention Description
Coronally Advanced Flap + Connective Tissue Graft
Intervention Type
Other
Intervention Name(s)
CAF
Intervention Description
Coronally Advanced Flap
Primary Outcome Measure Information:
Title
Complete Root Coverage (CRC)
Description
Complete Root Coverage: absence of gingival recession (Yes/No)
Time Frame
After the intervention (10 years)
Secondary Outcome Measure Information:
Title
Recession Reduction (RecRed)
Description
Change of the gingival recession, in mm
Time Frame
After the intervention (10 years)
Title
Root Coverage Aesthetic Score (RES)
Description
A scoring system ranging from 0 to 10
Time Frame
After the intervention (10 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Smoking < 20 cigarettes/day.
Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 15% (measured at four sites per tooth).
Presence of at least one RT2 (Cairo et al. 2011) buccal gingival recession > 2 mm of depth
Only gingival recessions localized at upper central and lateral incisors, canine, and first and second pre-molars associated with aesthetic problems and/ordental hypersensitivity were considered.
Presence of an identifiable CEJ
Exclusion Criteria:
Systemic diseases or pregnancy.
Systemic antibiotic therapy in the last 6 months.
Active periodontal disease with sites showing probing depth >4 mm.
Facility Information:
Facility Name
University of Florence
City
Florence
State/Province
Tuscany
ZIP/Postal Code
50100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Treatment of Single Maxillary Gingival Recession With Loss of Inter-dental Attachment. A Randomized Controlled Clinical Trial
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