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

NCT03676088 | Completed

• 1 other identifier: 02_D012_71663
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (5)

• 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: 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)

  6 months

Secondary Outcomes (3)

• probing pocket depth (PD)

  6 months

• clinical attachment level (CAL)

  6 months

• width of keratinized tissue (KTW)

  6 months

Study Arms (2)

Test group - rhPDGF-BB+MCAT+CTG

EXPERIMENTAL

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

Control group - MCAT+CTG

ACTIVE COMPARATOR

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

Interventions

root coverage 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

Also known as: root coverage with/without growth factor

Control group - MCAT+CTG; Test group - rhPDGF-BB+MCAT+CTG

Eligibility Criteria

• Age: 21 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Dr. Joann P George, MDS

  Krishnadevaraya College of Dental Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: May 8, 2018
• First Posted: September 18, 2018
• Study Start: November 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share