DFDBA and Amniotic Membrane in the Treatment of Periodontal Osseous Defects

Periodontal Intrabony Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02635529
• Other study ID #: 02_D012_44443
• Status: Recruiting
• Phase: Phase 4
• First received: December 7, 2015
• Last updated: December 16, 2015
• Start date: November 2013
• Est. completion date: January 2016

Study information

• Verified date: December 2015
• Source: Krishnadevaraya College of Dental Sciences & Hospital
• Contact: DR JOANN P GEORGE, MDS
• Phone: 9448541637
• Email: drjoannpaulinegeorge[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Intrabony Defects

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	Krishnadevaraya college of dental sciences and hospital	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Krishnadevaraya College of Dental Sciences & Hospital

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level (CAL)	Clinical attachment level measured in mm from cementoenamel junction to base of the pocket)	1 year
Secondary	Plaque index	Plaque index is measured for periodontal health	1 year
Secondary	Gingival index	Gingival index is measured for periodontal health	1 year
Secondary	Bleeding index	Bleeding index is measured for periodontal health	1 year
Secondary	Pocket Probing depth	Pocket probing depth level measured in mm from gingival margin to base of the pocket)	1 year
Secondary	Bone Fill	Bone fill measured in mm in radiographs from alveolar crest to base of the pocket	1 year

External Links

•   reference article