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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
Dr. D. Y. Patil Dental College & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 11, 2017
    Last Updated
    January 13, 2017
    Sponsor
    Dr. D. Y. Patil Dental College & Hospital
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    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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