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

NCT03023995 | Completed Phase 3

• 1 other identifier: DYP/2010/2PE
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Reduction in recession depth

  Recession depth reduction from baseline to 6 months

  Baseline to 6 months

Secondary Outcomes (4)

• Reduction in Mean plaque scores

  baseline to 6 months

• Reduction in mean gingival scores

  Baseline to 6 months

• Width of keratinised tissue

  baseline to 6 months

• Change Relative attachment level

  baseline to 6 months

Study Arms (2)

CAF with Platelet Rich Fibrin

EXPERIMENTAL

In test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it.

Procedure: CAF with Platelet rich fibrin

CAF with connective tissue graft

ACTIVE COMPARATOR

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

Procedure: CAF with connective tissue graft

Interventions

CAF with Platelet rich fibrin PROCEDURE

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 Platelet Rich Fibrin

CAF with connective tissue graft PROCEDURE

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.

CAF with connective tissue graft

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. D. Y. Patil Dental College & Hospital: lead

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 18, 2017
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share