Coronally Advanced Flap With Connective Tissue Graft and PRF for Recession Coverage

Gingival Recession Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023995
• Other study ID #: DYP/2010/2PE
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2017
• Last updated: January 13, 2017
• Start date: August 2015
• Est. completion date: August 2016

Study information

• Verified date: January 2017
• Source: Dr. D. Y. Patil Dental College & Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• CAF with Platelet rich fibrin
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.
• CAF with connective tissue graft
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. D. Y. Patil Dental College & Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in recession depth	Recession depth reduction from baseline to 6 months	Baseline to 6 months
Secondary	Reduction in Mean plaque scores	Mean plaque score reduction form baseline to 6 months	baseline to 6 months
Secondary	Reduction in mean gingival scores	Mean gingival score reduction from baseline to 6 months	Baseline to 6 months
Secondary	Width of keratinised tissue	Mean keratinised tissue increase from baseline to 6 months	baseline to 6 months
Secondary	Change Relative attachment level	Gain in relative attachment level from baseline to 6 months	baseline to 6 months