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DFDBA and Amniotic Membrane in the Treatment of Periodontal Osseous Defects

NCT ID: NCT02635529

Last Updated: 2015-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Periodontal Intrabony Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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OFD + DFDBA

Intrabony defects treatment was carried out with OFD + DFDBA

Group Type ACTIVE_COMPARATOR

OFD+ DFDBA

Intervention Type PROCEDURE

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.

OFD+DFDBA+AM

Intrabony defects treatment was carried out with OFD + DFDBA+ AM

Group Type ACTIVE_COMPARATOR

OFD+ DFDBA+ AM

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Krishnadevaraya College of Dental Sciences & Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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DR JOANN P GEORGE, MDS

Role: STUDY_DIRECTOR

Krishnadevaraya college of dental science and hospital

Locations

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Krishnadevaraya college of dental sciences and hospital

Bangalore, Karnataka, India

Site Status RECRUITING

Countries

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India

Central Contacts

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DR JOANN P GEORGE, MDS

Role: CONTACT

Phone: 9448541637

Email: [email protected]

Dr DEEPTHI D SALI, BDS (MDS)

Role: CONTACT

Phone: 8971216436

Email: [email protected]

Facility Contacts

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Dr Joann P George

Role: primary

References

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Kiany F, Moloudi F. Amnion membrane as a novel barrier in the treatment of intrabony defects: a controlled clinical trial. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):639-47. doi: 10.11607/jomi.3590.

Reference Type BACKGROUND
PMID: 26009915 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/?term=kiany+intrabony

reference article

Other Identifiers

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02_D012_44443

Identifier Type: -

Identifier Source: org_study_id