Coronally Advanced Flap and PRF With or Without Demineralized Freeze-dried Bone Allograft in Gingival Recession
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Coronally advanced flap and PRF with DFDBA; Coronally advanced flap and PRF without DFDBA
Intervention type(s): Procedure; Procedure
Intervention description(s): • 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.; . For Control site: i. Following pre-suturing of coronally avanced flap, exposed root and adjacent bone surface was covered by PRF membrane.
Other intervention name(s): Coronally advanced flap and Platelet-Rich Fibrin (PRF) with demineralized freeze-dried bone allograft (DFDBA Rocky Mountain Allograft); Coronally advanced flap and Platelet-Rich Fibrin (PRF) without demineralized freeze-dried bone allograft (DFDBA Rocky Mountain Allograft)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronally advanced flap; Gingival recession; Bone, demineralized; Bone, freeze-dried; platelet-rich fibrin; root coverage procedures