Clinical trial NCT03676088: Comparative Evaluation of CTG With and Without rhPDGF- BB Using Modified Coronally Advanced Tunnel for Root Coverage
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gingival recession depth (GRD)
timeFrame: 6 months
measure: 2. Gingival Recession Width (GRW)
timeFrame: 6 months
measure: Mean root coverage(MRC)
timeFrame: 6 months
measure: Complete root coverage(CRC)
timeFrame: 6 months
measure: coverage esthetic score(RCES)
timeFrame: 6 months
Secondary outcomes:
measure: probing pocket depth (PD)
timeFrame: 6 months
measure: clinical attachment level (CAL)
timeFrame: 6 months
measure: width of keratinized tissue (KTW)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Krishnadevaraya College of Dental Sciences
name: Dr. Joann P George, MDS
role: STUDY_DIRECTOR
References: