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

NCT02835430 | Completed Phase 4 DMC

• 1 other identifier: DPU/831(11)/2014
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingival Recession

Keywords

Coronally advanced flap; Gingival recession; Bone, demineralized; Bone, freeze-dried; platelet-rich fibrin; root coverage procedures

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline Recession Depth at 6 months.

Secondary Outcomes (4)

• Relative Attachment Level (RAL)

  Change from Baseline Relative Attachment Level at 6 months.

• Probing Depth

  Change from Baseline Probing Depth at 6 months.

• Width of Keratinized Gingiva (WKG)

  Change from Baseline Width of Keratinized Gingiva at 6 months.

• Percentage of Root Coverage

  At 6 months.

Study Arms (2)

Coronally advanced flap and PRF with DFDBA

EXPERIMENTAL

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

Procedure: Coronally advanced flap and PRF with DFDBA

Coronally advanced flap and PRF without DFDBA

ACTIVE COMPARATOR

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

Procedure: Coronally advanced flap and PRF without DFDBA

Interventions

Coronally advanced flap and PRF with DFDBA PROCEDURE

• 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.

Also known as: Coronally advanced flap and Platelet-Rich Fibrin (PRF) with demineralized freeze-dried bone allograft (DFDBA Rocky Mountain Allograft)

Coronally advanced flap and PRF with DFDBA

Coronally advanced flap and PRF without DFDBA PROCEDURE

. For Control site: i. Following pre-suturing of coronally avanced flap, exposed root and adjacent bone surface was covered by PRF membrane.

Also known as: Coronally advanced flap and Platelet-Rich Fibrin (PRF) without demineralized freeze-dried bone allograft (DFDBA Rocky Mountain Allograft)

Coronally advanced flap and PRF without DFDBA

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (2)

• 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.

  PMID: 24174758 BACKGROUND

• 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.

  PMID: 21976841 BACKGROUND

MeSH Terms

Conditions

Gingival Recession; Bone Diseases, Metabolic

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Poonam Dholakia

Study Record Dates

• First Submitted: July 9, 2016
• First Posted: July 18, 2016
• Study Start: November 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 19, 2016

Record last verified: 2016-07