Coronally Advanced Flap With Connective Tissue Graft and PRF for Recession Coverage
Primary Purpose
Gingival Recession
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
CAF with Platelet rich fibrin
CAF with connective tissue graft
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
Eligibility Criteria
Inclusion Criteria:
- Male and female patients with age group between 20 to 55 years,
- Presence of bilateral Millers Class I or II gingival recession defects,
- Periodontally healthy patients,
- Patient who demonstrate acceptable oral hygiene status prior to surgical procedure,
- Patient with a medium to deep palatal vault (for Control Group only),
- Patients agreed to give informed consent
Exclusion Criteria:
- History of prolonged use of antibiotics / steroids /immunosuppressive agents/aspirin/anticoagulants/other medications,
- Pregnant women,
- Smokers,
- History of systemic diseases like hypertension, diabetes, HIV, bone metabolic disorders, radiation therapy, immunosuppressive therapy, cancer, etc.
- Patients with unacceptable oral hygiene,
- Faulty tooth brushing technique,
- Mal-aligned tooth,
- Cervical abrasion,
- Teeth with prominent roots.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CAF with Platelet Rich Fibrin
CAF with connective tissue graft
Arm Description
In test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it.
In control group, connective tissue graft harvesting was carried out which was followed by placement of connective tissue graft on the recipient site. The connective tissue graft was placed on the recipient site and secured in position with 5-0 vicryl sutures
Outcomes
Primary Outcome Measures
Reduction in recession depth
Recession depth reduction from baseline to 6 months
Secondary Outcome Measures
Reduction in Mean plaque scores
Mean plaque score reduction form baseline to 6 months
Reduction in mean gingival scores
Mean gingival score reduction from baseline to 6 months
Width of keratinised tissue
Mean keratinised tissue increase from baseline to 6 months
Change Relative attachment level
Gain in relative attachment level from baseline to 6 months
Full Information
NCT ID
NCT03023995
First Posted
January 11, 2017
Last Updated
January 13, 2017
Sponsor
Dr. D. Y. Patil Dental College & Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03023995
Brief Title
Coronally Advanced Flap With Connective Tissue Graft and PRF for Recession Coverage
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. D. Y. Patil Dental College & Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Over the years, numerous surgical techniques such as free autografts and pedicle grafts have been introduced to correct gingival recession defects. Combination grafts with either autografts or allografts, and newer concepts of guided tissue regeneration (GTR), platelet concentrates, etc., were developed more recently to correct mucogingival defects. The use of PRF in various surgical procedures such as degree II furcations, intrabony defects, sinus floor segmentation during implant placement and on facial plastic surgeries have shown promising results. However to our knowledge, till this study was completed, no studies have been reported with the clinical outcomes of autologous platelet rich fibrin membrane for the treatment of localized gingival recession defects.
Hence, this study was designed to compare coronally advanced flap with platelet rich fibrin membrane versus subepithelial connective tissue graft in treatment of Miller's Class I and Class II gingival recession defects.
Detailed Description
The study design consist of twenty sites from ten patients were randomly selected by tossing the coin for the study, which are divided into test group( Root coverage was performed by coronally advanced flap with platelet rich fibrin membrane) and Control group (Root coverage was performed with coronal advanced flap with subepithelial connective tissue graft.)
The Surgical Procedure consist of i) Preparation of the recipient bed: After adequate anesthesia, trapezoidal flap was designed using three incisions which is followed by reflection of partial thickness flap was raised apical to the crest of the osseous dehiscence. A periosteal releasing incision was given to enable the coronal advancement of the flap. Following this, root planing was done and the mesial and distal interdental papillae were deepithelialized.
The exposed root surface was conditioned with tetracycline hydrochloride for four mins. (The tetracycline hydrochloride powder was mixed with saline in dappen dish and then applied on the root surface).
In test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it and secured with non resorbable sutures. The surgical area was covered with a non - eugenol periodontal dressing with post-operative antibiotics and analgesics and post-operative instructions that were given to all the patients.
In control group, connective tissue graft harvesting was carried out which was followed by placement of connective tissue graft on the recipient site. The connective tissue graft was placed on the recipient site and secured in position with vicryl sutures. The flap was coronally positioned over the connective tissue graft and secured with non resorbable sutures. The recipient bed was covered with a non-eugenol periodontal dressing with post-operative antibiotics and analgesics and post- operative instructions that were given to all the patients.
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
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAF with Platelet Rich Fibrin
Arm Type
Experimental
Arm Description
In test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it.
Arm Title
CAF with connective tissue graft
Arm Type
Active Comparator
Arm Description
In control group, connective tissue graft harvesting was carried out which was followed by placement of connective tissue graft on the recipient site. The connective tissue graft was placed on the recipient site and secured in position with 5-0 vicryl sutures
Intervention Type
Procedure
Intervention Name(s)
CAF with Platelet rich fibrin
Intervention Description
In test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it and secured with 4-0 non resorbable sutures.
Intervention Type
Procedure
Intervention Name(s)
CAF with connective tissue graft
Intervention Description
In control group, connective tissue graft was harvested, after which the flap was coronally positioned over the graft to completely cover it and secured with 4-0 non resorbable.
Primary Outcome Measure Information:
Title
Reduction in recession depth
Description
Recession depth reduction from baseline to 6 months
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Reduction in Mean plaque scores
Description
Mean plaque score reduction form baseline to 6 months
Time Frame
baseline to 6 months
Title
Reduction in mean gingival scores
Description
Mean gingival score reduction from baseline to 6 months
Time Frame
Baseline to 6 months
Title
Width of keratinised tissue
Description
Mean keratinised tissue increase from baseline to 6 months
Time Frame
baseline to 6 months
Title
Change Relative attachment level
Description
Gain in relative attachment level from baseline to 6 months
Time Frame
baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients with age group between 20 to 55 years,
Presence of bilateral Millers Class I or II gingival recession defects,
Periodontally healthy patients,
Patient who demonstrate acceptable oral hygiene status prior to surgical procedure,
Patient with a medium to deep palatal vault (for Control Group only),
Patients agreed to give informed consent
Exclusion Criteria:
History of prolonged use of antibiotics / steroids /immunosuppressive agents/aspirin/anticoagulants/other medications,
Pregnant women,
Smokers,
History of systemic diseases like hypertension, diabetes, HIV, bone metabolic disorders, radiation therapy, immunosuppressive therapy, cancer, etc.
Patients with unacceptable oral hygiene,
Faulty tooth brushing technique,
Mal-aligned tooth,
Cervical abrasion,
Teeth with prominent roots.
12. IPD Sharing Statement
Plan to Share IPD
No
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Coronally Advanced Flap With Connective Tissue Graft and PRF for Recession Coverage
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