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

NCT02835430 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-07-19

No results posted yet for this study

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

Interventions

PROCEDURE

Coronally advanced flap and PRF with DFDBA

• 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.

PROCEDURE

Coronally advanced flap and PRF without DFDBA

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-06-30
Completion
2016-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02835430 on ClinicalTrials.gov