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Gingival RecessionNCT03676088

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

A study testing root coverage in people with Gingival Recession, run by Krishnadevaraya College of Dental Sciences & Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 58 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
root coverage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
No sites listed yet
Study dates
Nov 2016to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 58 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • Patients with full mouth plaque score </= 10%(O'Leary 1972)
  • Patients with esthetic concerns.
  • Patients with thick gingival biotype >0.8mm

Who cannot join

  • 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.
Show all 9Show fewer
  • Drug and alcohol abuse
  • No occlusal interferences.
  • Patient with a known hypersensitivity to rhPDGF-BB.

About this study

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

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.

Read the 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.

Being tested
root coverage
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • root coverageProcedure or surgery

    Also called root coverage with/without growth factor

    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

Study groups in NCT03676088
Study groupRoleWhat they receive
Test group - rhPDGF-BB+MCAT+CTGExperimentalRoot 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
Receives: Procedure: root coverage
Control group - MCAT+CTGActive comparatorRoot 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
Receives: Procedure: root coverage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gingival recession depth (GRD)

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

    Measured: 6 months

  2. 2. Gingival Recession Width (GRW)

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

    Measured: 6 months

  3. Mean root coverage(MRC)

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

    Measured: 6 months

  4. Complete root coverage(CRC)

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

    Measured: 6 months

  5. 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)

    Measured: 6 months

Secondary outcomes (3)

  1. probing pocket depth (PD)

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

    Measured: 6 months

  2. clinical attachment level (CAL)

    measured as Gingival Recession Depth + Probing Depth

    Measured: 6 months

  3. 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).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2018
  2. Study startNov 2016
  3. Primary completionJul 2018
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03676088
Sponsor's protocol ID
02_D012_71663
Status last verified
Sep 2018
First submitted
8 May 2018
Last updated
25 Sep 2018
Results posted
No
FDA-regulated drug
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing root coverage in people with Gingival Recession, run by Krishnadevaraya College of Dental Sciences & Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gingival recession depth (GRD) (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03676088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.

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