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Completed

NCT Number: NCT03676088

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

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.

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Key information

Age range

21 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: root coverage with/without growth factor

Primary outcomes

  1. Gingival recession depth (GRD)

    Time frame: 6 months

    measured as the distance from the Cemento Enamel Junction to the gingival margin

  2. 2. Gingival Recession Width (GRW)

    Time frame: 6 months

    measured as the distance between the mesial gingival margin and distal gingival margin

  3. Mean root coverage(MRC)

    Time frame: 6 months

    (Baseline recession depth - 6 month recession depth/Baseline recession depth)*100

  4. Complete root coverage(CRC)

    Time frame: 6 months

    root coverage regarded as complete with gingival margin located at the level of Cemento Enamel Junction

  5. coverage esthetic score(RCES)

    Time frame: 6 months

    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)

Secondary outcomes

  1. probing pocket depth (PD)

    Time frame: 6 months

    measured as the distance from the gingival margin to the base of gingival sulcus

  2. clinical attachment level (CAL)

    Time frame: 6 months

    measured as Gingival Recession Depth + Probing Depth

  3. width of keratinized tissue (KTW)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 18, 2018
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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