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

Comparative Evaluation of rhPDGF- BB With Modified Coronally Advanced Tunnel and CTG Versus Modified Coronally Advanced Tunnel With CTG Alone for Root Coverage in Multiple Mandibular Gingival Recession Defects- A RCT

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: root coverage

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 58 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Procedure: 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; Other Names: root coverage with/without growth factor
ACTIVE_COMPARATOR: 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	Procedure: 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; Other Names: root coverage with/without growth factor

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
probing pocket depth (PD)	measured as the distance from the gingival margin to the base of gingival sulcus	6 months
clinical attachment level (CAL)	measured as Gingival Recession Depth + Probing Depth	6 months
width of keratinized tissue (KTW)	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).	6 months

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
• Investigators: Study Director: Dr. Joann P George, MDS, Krishnadevaraya college of dental sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): July 1, 2018
• Study Completion (ACTUAL): July 1, 2018

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: September 15, 2018
• First Posted (ACTUAL): September 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 23, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: 02_D012_71663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No