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

Not Applicable

Completed

• Conditions: Gingival Recession

• Registration Number: NCT03676088
• Lead Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2018-05-08
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-15
• Study First Posted: 2018-09-18
• Last Update Submitted: 2018-09-23
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gingival recession depth (GRD)	6 months	measured as the distance from the Cemento Enamel Junction to the gingival margin
2. Gingival Recession Width (GRW)	6 months	measured as the distance between the mesial gingival margin and distal gingival margin
Mean root coverage(MRC)	6 months	(Baseline recession depth - 6 month recession depth/Baseline recession depth)\*100
Complete root coverage(CRC)	6 months	root coverage regarded as complete with gingival margin located at the level of Cemento Enamel Junction
coverage esthetic score(RCES)	6 months	The Aesthetic evaluation was performed according to the root coverage aesthetic score system (RES); Five Variables evaluated which are as follows: 1. Level of Gingival margin (GM); 2. Marginal Tissue Contour (MTC); 3. Soft Tissue Texture (STT); 4. Mucogingival Junction(MJ) alignment; 5. Gingival Colour (GC)

Secondary Outcome Measures

Name	Time	Method
probing pocket depth (PD)	6 months	measured as the distance from the gingival margin to the base of gingival sulcus
clinical attachment level (CAL)	6 months	measured as Gingival Recession Depth + Probing Depth
width of keratinized tissue (KTW)	6 months	measured as the distance from the mucogingival junction to the gingival margin , with the mucogingival junction location determined using a visual method (Schiller's Potassium Iodide Solution).