Comparative Evaluation of CTG With and Without rhPDGF- BB Using Modified Coronally Advanced Tunnel for Root Coverage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-07-31

Brief Summary

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The present study is a human, prospective, single centre, single blind, comparative controlled randomized clinical trial for the treatment of Miller's Class I, II or combination of class I and II mandibular recession and comparing the clinical outcomes prior to and 6 months after treatment. The trial is in accordance to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

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Detailed Description

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24 recession defects were selected in patients who were systemically and periodontally healthy, satisfying the determined inclusion criteria. Patients with at least two or more teeth having Miller's class I , II or combination of class I and II mandibular recession defects were included in the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, surgical procedure involved, potential benefits and risks associated with the surgical procedure and a written informed consent was obtained from all patients.

The patients were assigned into two treatment groups (test and control). The test group was treated with recombinant human Platelet Derived Growth Factor-BB and Modified Coronally Advanced Tunnel +Connective Tissue Graft whereas the control group was treated by Modified Coronally Advanced Tunnel +Connective Tissue Graft alone.

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients were assigned into two treatment groups (test and control). The test group was treated with recombinant human Platelet Derived Growth Factor-BB and Modified Coronally Advanced Tunnel +Connective Tissue Graft whereas the control group was treated by Modified Coronally Advanced Tunnel +Connective Tissue Graft alone.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Computer generated randomization sequence was obtained by the assistant. Allocation concealment was achieved using a sealed coded opaque envelope containing the treatment of the specific subject The sealed envelope containing treatment assignment was opened immediately prior to surgery to prevent surgeon bias

Study Groups

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Test group - rhPDGF-BB+MCAT+CTG

Root coverage surgical procedure.The patients were assigned into two treatment groups (test and control). Intervention - The test group recession coverage is treated with modified coronally advanced tunnel with connective tissue graft with recombinant human platelet derived growth factor- BB

Group Type EXPERIMENTAL

root coverage

Intervention Type PROCEDURE

recession coverage is treated with modified coronally advanced tunnel with connective tissue graft with recombinant human platelet derived growth factor- BB for Experimental: Test group and without recombinant human platelet derived growth factor- BB for Active Comparator: Control group

Control group - MCAT+CTG

Root coverage surgical procedure.The patients were assigned into two treatment groups (test and control). Intervention - The control group recession coverage is treated with modified coronally advanced tunnel with connective tissue graft alone

Group Type ACTIVE_COMPARATOR

root coverage

Intervention Type PROCEDURE

recession coverage is treated with modified coronally advanced tunnel with connective tissue graft with recombinant human platelet derived growth factor- BB for Experimental: Test group and without recombinant human platelet derived growth factor- BB for Active Comparator: Control group

Interventions

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root coverage

recession coverage is treated with modified coronally advanced tunnel with connective tissue graft with recombinant human platelet derived growth factor- BB for Experimental: Test group and without recombinant human platelet derived growth factor- BB for Active Comparator: Control group

Intervention Type PROCEDURE

Other Intervention Names

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root coverage with/without growth factor

Eligibility Criteria

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Inclusion Criteria

* Patients fulfilling the following criteria were included in the study:-

* Two or more teeth with Miller's class I and II or combined class I and II recession defects in mandibular anteriors.
* Age group 21-58 years.
* Patients with healthy or treated periodontal conditions.
* Patients willing to participate in the study.
* Absence of uncontrolled medical conditions.
* Patients with full mouth plaque score \</= 10%(O'Leary 1972)
* Patients with esthetic concerns.
* Patients with thick gingival biotype \>0.8mm

Exclusion Criteria

* Pregnant or lactating females.
* Tobacco smoking.
* Uncontrolled medical conditions.
* Untreated periodontal conditions.
* Use of systemic antibiotics in the past 3 months.
* Patients treated with any medication known to cause gingival hyperplasia.
* Drug and alcohol abuse
* No occlusal interferences.
* Patient with a known hypersensitivity to rhPDGF-BB.

Minimum Eligible Age

21 Years

Maximum Eligible Age

58 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes