Porous and Non-porous Bone Grafts in Intra-bony Periodontal Defects

NCT ID: NCT02463006

Last Updated: 2015-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-05-31

Brief Summary

Till date, no study has been reported in the literature where porous bioactive glass was used for the management of periodontal osseous defects. In this context, the present study is designed to assess the efficacy of the porous variant of bioactive glass and compare with that of nonporous variant using cone beam computed tomography.

Detailed Description

OBJECTIVES:

1. To evaluate clinically the periodontal healing with Porous variant of Bioactive Glass placed in the intra bony defects at an interval of 6 months.

2. To evaluate clinically the periodontal healing with Non Porous variant of Bioactive Glass placed in the intra bony defects at an interval of 6 months.

3. To evaluate the radiographic changes in the intra bony defect grafted with Porous variant of Bioactive Glass at baseline and an interval of 6 months.

4. To evaluate the radiographic changes in the intra bony defect grafted with Non Porous variant of Bioactive Glass at baseline and an interval of 6 months.

5. To compare clinically soft tissue healing for sites grafted with Porous variant of Bioactive Glass and sites grafted with Non Porous variant of Bioactive Glass in the treatment of periodontal intra bony defects at an interval of 6 months.

6. To compare the radiographic changes for sites grafted with Porous variant and sites grafted with Non Porous of Bioactive Glass in the treatment of periodontal intra bony defects at an interval of 6 months.

Conditions

Periodontal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

porous bone graft group

Intervention: Flap surgery procedure with porous bone grafting (Periooglass)

Group Type: EXPERIMENTAL

Porous variant of Bioactive Glass.

Intervention Type: DRUG

Flap surgery with Porous variant of Bioactive Glass.

Non-porous bone gaft group

Intervention: Flap surgery procedure with non-porous bone grafting (Novabone morsels)

Group Type: ACTIVE_COMPARATOR

Non porous variant of Bioactive Glass.

Intervention Type: DRUG

Flap surgery with non-Porous variant of Bioactive Glass.

Interventions

Porous variant of Bioactive Glass.

Flap surgery with Porous variant of Bioactive Glass.

Intervention Type: DRUG

Non porous variant of Bioactive Glass.

Flap surgery with non-Porous variant of Bioactive Glass.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age: 18-55 years.

2. Probing Depth >5mm.

Exclusion Criteria

1. History of periodontal treatment last six months.

2. Bleeding disorders.

3. Gross oral pathology.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. D. Y. Patil Dental College & Hospital

OTHER

Sponsor Role: lead

Responsible Party

D. Gopalakrishnan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Gokhale ST, Dwarakanath CD. The use of a natural osteoconductive porous bone mineral (Bio-Oss) in infrabony periodontal defects. J Indian Soc Periodontol. 2012 Apr;16(2):247-52. doi: 10.4103/0972-124X.99270.

Reference Type: RESULT

PMID: 23055593 (View on PubMed)

Wohlfahrt JC, Aass AM, Ronold HJ, Heijl L, Haugen HJ, Lyngstadaas SP. Microcomputed tomographic and histologic analysis of animal experimental degree II furcation defects treated with porous titanium granules or deproteinized bovine bone. J Periodontol. 2012 Feb;83(2):211-21. doi: 10.1902/jop.2011.110128. Epub 2011 Jun 21.

Reference Type: RESULT

PMID: 21692628 (View on PubMed)

Other Identifiers

DYPDCH/12/PG16

Identifier Type: -

Identifier Source: org_study_id