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

Krishnadevaraya College of Dental Sciences & Hospital

Status: Completed

Conditions: Gingival Recession

Treatments: Procedure: root coverage

Study type: Interventional

Funder types: Other

Identifiers

NCT03676088

02_D012_71663

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 6 patients

Sex: All

Ages: 21 to 58 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups

Test group - rhPDGF-BB+MCAT+CTG

Experimental group

Description:

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

Treatment:

Procedure: root coverage

Control group - MCAT+CTG

Active Comparator group

Description:

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

Treatment:

Procedure: root coverage