DFDBA and Amniotic Membrane in the Treatment of Periodontal Osseous Defects

December 16, 2015 updated by: Krishnadevaraya College of Dental Sciences & Hospital

A Clinical and Radiographic Evaluation of DFDBA (Demineralised Freeze Dried Bone Allograft) With Amniotic Membrane (AM) in the Treatment of Periodontal Osseous Defects-12 Month Randomized Controlled Clinical Trial

Amniotic membrane may be considered as a biologically active scaffold, which in combination with Bone Replacement Grafts (BRG) can be widely used to reconstruct periodontal Intrabony Defects (IBDs), due to the presence of stem cells and growth factors. The goal of the present study was to evaluate if a biologic AM in combination with DFDBA applied in periodontal IBDs would enhance the regeneration of periodontium.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Periodontitis is a bacterially induced inflammatory disease of the supporting tissues of the teeth. It is one of the major dental diseases that affect human populations worldwide and has a huge economic impact on national health care systems.The consequence of periodontitis is commonly the formation of intrabony defects.Intrabony defects are more amenable for regenerative procedures. Periodontal regeneration remains a fundamental therapeutic goal for the preservation of teeth through the restoration of health, function, and esthetics of the periodontium. Several treatment procedures like open flap debridement (OFD), autogenous bone replacement bone grafts (BRG), guided tissue regeneration (GTR), bioactive agents like EMD, rhPDGF-BB, laser assisted regeneration (LAR) have shown histologic proof of principle that the periodontal ligament apparatus can be regenerated in human studies. Intrabony defects with the depth of >3 mm and radiographic defect angle ≤ 25 are amenable for periodontal regeneration. DFDBA has stood the test of time and has shown consistent good quality patient oriented evidence in achieving periodontal regeneration with long term stability. GTR techniques have shown added advantage of space maintenance, clot stability, guided cell population, epithelial cell occlusion and the combination therapies. Periodontal regeneration with GTR and BRG demonstrates better results as compared with GTR alone. More recently in the realm of reconstructive biology, the concept of Tissue engineering (TE) has been introduced which utilizes mechanical, cellular or biologic mediators to facilitate reconstruction/regeneration of a particular tissue.

The combination of this novel biologic membrane AM and the already established BRG-DFDBA can be an added advantage in treatment of IBDs. To the best of the investigators knowledge only one clinical trial reports this combination therapy in the scientific literature. There is a need for further research in this area.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 562157
        • Recruiting
        • Krishnadevaraya college of dental sciences and hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Age group of 25-45 years
  • Moderate periodontitis with pocket probing depth more than 6mm
  • Bilaterally similar intrabony defects
  • Systemically healthy patients
  • Vital or endodontically treated teeth
  • Good compliance

Exclusion criteria:

  • Medically compromised
  • Pregnant and lactating women
  • Smoking
  • Teeth with mobility and furcation involvement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: OFD + DFDBA
Intrabony defects treatment was carried out with OFD + DFDBA
Procedure: OFD+ DFDBA
After Phase I therapy, patient's were assigned for OFD+DFDBA group. Mucoperiosteal flap were reflected.After Open Flap Debridement (OFD), DFDBA graft was placed for the treatment of intrabony defects.
Active Comparator: OFD+DFDBA+AM
Intrabony defects treatment was carried out with OFD + DFDBA+ AM
Procedure: OFD+ DFDBA+ AM
After Phase I therapy, patient's were assigned for OFD+DFDBA + AM group. Mucoperiosteal flap were reflected. After Open Flap Debridement (OFD). DFDBA and AM was placed for the treatment of intrabony defects.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical attachment level (CAL)
Time Frame: 1 year
Clinical attachment level measured in mm from cementoenamel junction to base of the pocket)
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plaque index
Time Frame: 1 year
Plaque index is measured for periodontal health
1 year
Gingival index
Time Frame: 1 year
Gingival index is measured for periodontal health
1 year
Bleeding index
Time Frame: 1 year
Bleeding index is measured for periodontal health
1 year
Pocket Probing depth
Time Frame: 1 year
Pocket probing depth level measured in mm from gingival margin to base of the pocket)
1 year
Bone Fill
Time Frame: 1 year
Bone fill measured in mm in radiographs from alveolar crest to base of the pocket
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Krishnadevaraya College of Dental Sciences & Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: DR JOANN P GEORGE, MDS, Krishnadevaraya College of Dental Science and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 02_D012_44443

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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