Treatment of Gingival Recession Using Gingival Composite Restoration Versus Coronally Advanced Flap
Primary Purpose
Gingival Recession
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
coronally advanced flap
restorative intervention
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
Eligibility Criteria
Inclusion Criteria:
- participants with at least one buccal gingival recession
- O'Leary plaque index less than 20%
- motivated participants willing to complete the follow up
Exclusion Criteria:
- prior surgical or restorative interventions at the recession defect
- smokers
- pregnant participants
- systemic conditions contraindicating dental management
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment of gingival recession with colored composite
Treatment of gingival recession with coronally advanced flap
Arm Description
Composite restoration will be applied to the gingival recession defect
coronally advanced flap at the gingival defect
Outcomes
Primary Outcome Measures
post-operative pain
self-reported pain on visual analogue scale (VAS)
Secondary Outcome Measures
post-operative pain
self-reported pain on VAS
overall quality of life: questionnaire
self reported through a questionnaire
Reported post-operative satisfaction
questionnaire
mean root coverage
percentage
complete root coverage
percentage
Probing depth
in mm
Recession depth
in mm
Plaque index
percentage
Bleeding index
percentage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04584931
Brief Title
Treatment of Gingival Recession Using Gingival Composite Restoration Versus Coronally Advanced Flap
Official Title
Treatment of Gingival Recession Using Gingival Composite Restoration Versus Coronally Advanced Flap: Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
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
Treatment of gingival recession requires favourable anatomical conditions and the use of invasive surgical approaches. Hence, these procedures are not always indicated in all cases and can cause great pain and morbidity. Coloured composite restorations that mimic the lost gingival tissues can provide a non-invasive and simple solution regardless of the recession soft and hard-tissue conditions.
Detailed Description
Gingival recession (also known as marginal tissue recession) is defined as the downward displacement of the soft tissues around teeth that would have been otherwise covering the cemento-enamel junction (CEJ), thus exposing the root surface clinically. Recession is one of the most prevalent mucogingival conditions worldwide, affecting between 30% to 100% of the overall population, and its incidence increases with age. Main concerns regarding recession ranging from unacceptable esthetics to the patient, dentinal hypersensitivity, development of carious and non-carious cervical lesions, or impairment of adequate plaque control.
The ultimate aim for treating gingival recession is to provide complete coverage of the root with optimal esthetics and function. A wide range of surgical interventions have been investigated to provide for successful root coverage including rotational and advanced pedicle flaps, free gingival grafts, or regenerative modalities such as guided tissue regeneration. The predictability of surgical techniques depends on patient related factors such as smoking, oral hygiene care and compliance, defect related conditions like depth, width, gingival thickness and interdental attachment level, and finally, operator related skills and experience.
Coronally advanced flap (CAF) with or without the use of connective tissue graft is considered the gold standard for root coverage due to its ability to achieve complete root coverage in favorable defects, superior esthetic outcomes and blending with surrounding gingiva, and the possible realignment and increase in keratinized tissue height. On the other hand, CAF is faced with multiple drawbacks. Complete root coverage in CAF procedures is not predictable in cases with interdental attachment loss. The surgery poses added morbidity, discomfort and pain, and donor site (if present) may augment these complications. Scar formation as a result of incisions or sutures may reduce the overall esthetic appeal. It requires frequent follow-up visits and arduous post-operative instructions. Post-operative results are not stable over long period of time with frequent relapse. The procedure cannot be performed in cases with systemic contraindications for surgical interventions. And finally, it is time-consuming and requires surgical skill and training of the operator.
To overcome all of the abovementioned drawbacks of CAF, composite resin restorative material with pink shades known as "gingival composite" has been proposed to manage gingival recessions. Root coverage with composite is known to effectively reduce dentinal hypersensitivity effectively. Hence, managing gingival recession with this restorative procedure, the patients concerns regarding esthetics or hypersensitivity can be directly addressed using a simple and fast technique. Compared to CAF, restorative procedure shows less pain, morbidity and bleeding, and it does not involve surgical incisions/sutures and hence avoids no scar formation. Pink composite can be presented as a solution in cases that are not expected to benefit from CAF such as RT3, and it can treat carious and non-carious cervical lesions in one step. In addition, it requires less operative time and can be performed by general practitioners and with conventional armamentarium.
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
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment of gingival recession with colored composite
Arm Type
Experimental
Arm Description
Composite restoration will be applied to the gingival recession defect
Arm Title
Treatment of gingival recession with coronally advanced flap
Arm Type
Active Comparator
Arm Description
coronally advanced flap at the gingival defect
Intervention Type
Procedure
Intervention Name(s)
coronally advanced flap
Intervention Description
flap surgery to achieve root coverage at gingival recession defect
Intervention Type
Procedure
Intervention Name(s)
restorative intervention
Intervention Description
colored composite restoration to camouflage the gingival recession defect
Primary Outcome Measure Information:
Title
post-operative pain
Description
self-reported pain on visual analogue scale (VAS)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
post-operative pain
Description
self-reported pain on VAS
Time Frame
1,3,5,14 days
Title
overall quality of life: questionnaire
Description
self reported through a questionnaire
Time Frame
6 months
Title
Reported post-operative satisfaction
Description
questionnaire
Time Frame
6 months
Title
mean root coverage
Description
percentage
Time Frame
6 months
Title
complete root coverage
Description
percentage
Time Frame
6 months
Title
Probing depth
Description
in mm
Time Frame
baseline, 6 months
Title
Recession depth
Description
in mm
Time Frame
baseline, 6 months
Title
Plaque index
Description
percentage
Time Frame
baseline, 6 months
Title
Bleeding index
Description
percentage
Time Frame
baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
participants with at least one buccal gingival recession
O'Leary plaque index less than 20%
motivated participants willing to complete the follow up
Exclusion Criteria:
prior surgical or restorative interventions at the recession defect
smokers
pregnant participants
systemic conditions contraindicating dental management
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Elfana, MSc
Phone
+2011101102221
Email
ahmed.abdelraouf@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Karim Fawzy El-Sayed, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Gingival Recession Using Gingival Composite Restoration Versus Coronally Advanced Flap
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