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Coronally Advanced Flap and PRF With or Without Demineralized Freeze-dried Bone Allograft in Gingival Recession

Primary Purpose

Gingival Recession

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Coronally advanced flap and PRF with DFDBA
Coronally advanced flap and PRF without DFDBA
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 focused on measuring Coronally advanced flap, Gingival recession, Bone, demineralized, Bone, freeze-dried, platelet-rich fibrin, root coverage procedures

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age group of 18-45 years from both sexes.
  • Presence of bilateral isolated gingival recession classified as Miller's class I or class II recession defects in anteriors and/or premolars.
  • Systemically healthy patients.
  • Patients willing to comply with all study-related procedures and available for follow-up.
  • Ability to maintain good oral hygiene.

Exclusion Criteria:

  • History of prolonged use of antibiotics/steroids/immunosuppressive agents/aspirin/ anticoagulants/other medications.
  • Pregnant/Lactating women.
  • Tobacco in any form.
  • History of systemic diseases like hypertension, diabetes, HIV, bone metabolic disorders, radiation therapy, immunosuppressive therapy, cancer.
  • Patients with unacceptable oral hygiene.
  • Faulty tooth brushing technique.
  • Malaligned teeth.
  • Cervical abrasion.
  • Unwilling patients.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Coronally advanced flap and PRF with DFDBA

    Coronally advanced flap and PRF without DFDBA

    Arm Description

    Coronally advanced flap and platelet-rich fibrin membrane with demineralized freeze-dried bone allograft.

    Coronally advanced flap and Platelet-rich fibrin membrane without demineralized freeze-dried bone allograft.

    Outcomes

    Primary Outcome Measures

    Recession Depth (RD)
    Recession depth (RD), measured from the cemento-enamel junction (CEJ) to the most apical extension of gingival margin at Baseline and 6 months post-surgery.

    Secondary Outcome Measures

    Relative Attachment Level (RAL)
    Relative Attachment Level from the lower border of stent to the base of sulcus at Baseline and 6 months post-surgery.
    Probing Depth
    Probing depth was recorded from the crest of gingival margin to the base of gingival sulcus at Baseline and 6 months post-surgery.
    Width of Keratinized Gingiva (WKG)
    Width of Keratinized Gingiva (WKG) measured from the gingival margin to the mucogingival junction at Baseline and 6 months post-surgery.
    Percentage of Root Coverage
    (Preoperative recession depth - Postoperative recession depth)/ Preoperative recession depth * 100, at 6 months post-surgery.

    Full Information

    First Posted
    July 9, 2016
    Last Updated
    July 16, 2016
    Sponsor
    Dr. D. Y. Patil Dental College & Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02835430
    Brief Title
    Coronally Advanced Flap and PRF With or Without Demineralized Freeze-dried Bone Allograft in Gingival Recession
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    July 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
    Yes

    5. Study Description

    Brief Summary
    Gingival recession is defined as the apical migration of gingival margin beyond cemento-enamel junction with the exposure of root surface. More than 20% of the population presents one or more tooth surfaces with gingival recession. The main conditions leading to the development of this defect are gingival anatomical factors, chronic trauma, periodontitis, malposed tooth and dentinal hypersensitivity. The main goal of treating gingival recession is to restore the gingival margin to cement-enamel junction (CEJ) and normal sulcus with a functional attachment. A recent innovation in Guided Tissue Regeneration (GTR) technique is the use of second generation platelet concentrate, called as Platelet-Rich Fibrin membrane (PRF) that contains growth factors and cicatricial properties for root coverage procedures. Space is necessary to provide a channel for the migration of progenitor cells towards and on the denuded root surface, where they can differentiate into cementum and periodontal ligament cells. Since the gingival recession defects are non-space making, it may be difficult using the membrane technique alone, and hence, the use of a graft material underneath the membrane may help to resolve this problem. Root coverage tended to be better with the addition of demineralized freeze-dried bone allograft (DFDBA). These allografts prevent the collapse of membrane into the defect, stimulate the proliferation of osteogenic progenitor cells, and are thus, capable of promoting regeneration of attachment apparatus. Till date, no study is available in the literature on clinical evaluation of CAF (Coronally Advanced Flap)+PRF+DFDBA vs CAF+PRF for the management of gingival recession defects. And hence, this study is designed to evaluate the clinical efficacy of DFDBA (Rocky Mountain Particulate Allograft) for the management of isolated gingival recession defects.
    Detailed Description
    SURGICAL PROCEDURE: I. After patient selection and obtaining informed consent, a total of 10 bilateral facial, Miller's Class I or II gingival recession defects were consecutively treated. Test and Control site were randomly assigned by flip coin technique. II. The Test sites were treated using CAF+PRF+DFDBA and the Control sites were treated using CAF+PRF. III. Under local anesthesia, an intrasulcular incision was given using a surgical bade on the buccal aspect of the involved tooth. The incision was extended horizontally to dissect the buccal aspect of the adjacent papillae, both mesially and distally, leaving the gingival margin of the adjacent teeth untouched. Two oblique releasing incisions were made from the mesial and distal extremities of the horizontal incision beyond the mucogingival junction. IV. Partial-full-partial thickness flap was raised and extended beyond the mucogingival junction. The exposed root surface was thoroughly debrided and prepared to reduce the root convexities, if any. V. A mesio-distal and apical dissection parallel to the vestibular lining mucosa was performed to release the residual muscle tension and facilitate the passive coronal displacement of the flap. The papillae adjacent to the involved tooth was de-epithelialized. Preparation of PRF: Preoperatively, a 10 ml of blood sample of the patient without anticoagulant was collected in a test tube and centrifuged immediately at 3000 rpm for 10 minutes. The platelet-rich fibrin clot was separated from the other two layers (acellular plasma and red blood cells) and prepared in the form of a membrane by squeezing out fluids from the fibrin clot. . For Test site: i. Following pre-suturing, DFDBA (Rocky Mountain Particulate Allograft) was placed over the exposed root and adjacent bone surface and subsequently covered by PRF membrane. ii. Flap was coronally displaced without tension and sutured using 4-0 mersilk non-resorbable suture. iii. Additional lateral sutures were placed to close the releasing incisions. . For Control site: i. Following pre-suturing, exposed root and adjacent bone surfaces were covered by PRF membrane. ii. Flap was coronally displaced without tension and sutured using 4-0 mersilk non-resorbable suture. iii. Additional lateral sutures were placed to close the releasing incisions. Post-surgical protocols: Postoperative instructions were given along with a recommendation to refrain from mechanical cleaning on the surgical areas. Periodontal dressing was placed at both Test and Control sites. Patients were instructed to apply 0.12% chlorhexidine solution (1:1 dilution) with a cotton swab twice daily for 14 days. Analgesics and antibiotics were prescribed and suture removal was performed 14 days post-surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession
    Keywords
    Coronally advanced flap, Gingival recession, Bone, demineralized, Bone, freeze-dried, platelet-rich fibrin, root coverage procedures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Coronally advanced flap and PRF with DFDBA
    Arm Type
    Experimental
    Arm Description
    Coronally advanced flap and platelet-rich fibrin membrane with demineralized freeze-dried bone allograft.
    Arm Title
    Coronally advanced flap and PRF without DFDBA
    Arm Type
    Active Comparator
    Arm Description
    Coronally advanced flap and Platelet-rich fibrin membrane without demineralized freeze-dried bone allograft.
    Intervention Type
    Procedure
    Intervention Name(s)
    Coronally advanced flap and PRF with DFDBA
    Other Intervention Name(s)
    Coronally advanced flap and Platelet-Rich Fibrin (PRF) with demineralized freeze-dried bone allograft (DFDBA Rocky Mountain Allograft)
    Intervention Description
    • For Test site: i. Following pre-suturing of coronally advanced flap, DFDBA (Rocky Mountain Particulate Allograft) was placed over the exposed root and adjacent bone surface and subsequently covered by PRF membrane.
    Intervention Type
    Procedure
    Intervention Name(s)
    Coronally advanced flap and PRF without DFDBA
    Other Intervention Name(s)
    Coronally advanced flap and Platelet-Rich Fibrin (PRF) without demineralized freeze-dried bone allograft (DFDBA Rocky Mountain Allograft)
    Intervention Description
    . For Control site: i. Following pre-suturing of coronally avanced flap, exposed root and adjacent bone surface was covered by PRF membrane.
    Primary Outcome Measure Information:
    Title
    Recession Depth (RD)
    Description
    Recession depth (RD), measured from the cemento-enamel junction (CEJ) to the most apical extension of gingival margin at Baseline and 6 months post-surgery.
    Time Frame
    Change from Baseline Recession Depth at 6 months.
    Secondary Outcome Measure Information:
    Title
    Relative Attachment Level (RAL)
    Description
    Relative Attachment Level from the lower border of stent to the base of sulcus at Baseline and 6 months post-surgery.
    Time Frame
    Change from Baseline Relative Attachment Level at 6 months.
    Title
    Probing Depth
    Description
    Probing depth was recorded from the crest of gingival margin to the base of gingival sulcus at Baseline and 6 months post-surgery.
    Time Frame
    Change from Baseline Probing Depth at 6 months.
    Title
    Width of Keratinized Gingiva (WKG)
    Description
    Width of Keratinized Gingiva (WKG) measured from the gingival margin to the mucogingival junction at Baseline and 6 months post-surgery.
    Time Frame
    Change from Baseline Width of Keratinized Gingiva at 6 months.
    Title
    Percentage of Root Coverage
    Description
    (Preoperative recession depth - Postoperative recession depth)/ Preoperative recession depth * 100, at 6 months post-surgery.
    Time Frame
    At 6 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age group of 18-45 years from both sexes. Presence of bilateral isolated gingival recession classified as Miller's class I or class II recession defects in anteriors and/or premolars. Systemically healthy patients. Patients willing to comply with all study-related procedures and available for follow-up. Ability to maintain good oral hygiene. Exclusion Criteria: History of prolonged use of antibiotics/steroids/immunosuppressive agents/aspirin/ anticoagulants/other medications. Pregnant/Lactating women. Tobacco in any form. History of systemic diseases like hypertension, diabetes, HIV, bone metabolic disorders, radiation therapy, immunosuppressive therapy, cancer. Patients with unacceptable oral hygiene. Faulty tooth brushing technique. Malaligned teeth. Cervical abrasion. Unwilling patients.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24174758
    Citation
    Padma R, Shilpa A, Kumar PA, Nagasri M, Kumar C, Sreedhar A. A split mouth randomized controlled study to evaluate the adjunctive effect of platelet-rich fibrin to coronally advanced flap in Miller's class-I and II recession defects. J Indian Soc Periodontol. 2013 Sep;17(5):631-6. doi: 10.4103/0972-124X.119281.
    Results Reference
    background
    PubMed Identifier
    21976841
    Citation
    Nanditha S, Priya MS, Sabitha S, Arun KV, Avaneendra T. Clinical evaluation of the efficacy of a GTR membrane (HEALIGUIDE) and demineralised bone matrix (OSSEOGRAFT) as a space maintainer in the treatment of Miller's Class I gingival recession. J Indian Soc Periodontol. 2011 Apr;15(2):156-60. doi: 10.4103/0972-124X.84386.
    Results Reference
    background

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    Coronally Advanced Flap and PRF With or Without Demineralized Freeze-dried Bone Allograft in Gingival Recession

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