Clinical trial NCT03023995: Coronally Advanced Flap With Connective Tissue Graft and PRF for Recession Coverage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingival Recession
Lead sponsor: Dr. D. Y. Patil Dental College & Hospital
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Reduction in recession depth
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Reduction in Mean plaque scores
timeFrame: baseline to 6 months
measure: Reduction in mean gingival scores
timeFrame: Baseline to 6 months
measure: Width of keratinised tissue
timeFrame: baseline to 6 months
measure: Change Relative attachment level
timeFrame: baseline to 6 months
Other outcomes:
Locations:
Study officials:
References: