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

Periodontal Disease Clinical Trial

Official title:

Comparative Evaluation of Porous and Non Porous Variants of Bioactive Glass in the Treatment of Periodontal Intrabony Defects: A Cone Beam Computed Tomography Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02463006
• Other study ID #: DYPDCH/12/PG16
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 29, 2015
• Last updated: June 2, 2015
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Dr. D. Y. Patil Dental College & Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• INCLUSION CRITERIA

1. Age: 18-55 years.

2. Probing Depth >5mm.

Exclusion Criteria:

• EXCLUSION CRITERIA

1. History of periodontal treatment last six months.

2. Bleeding disorders.

3. Gross oral pathology.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Intervention

Drug:
• Porous variant of Bioactive Glass.
Flap surgery with Porous variant of Bioactive Glass.
• Non porous variant of Bioactive Glass.
Flap surgery with non-Porous variant of Bioactive Glass.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. D. Y. Patil Dental College & Hospital

References & Publications (2)

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. — View Citation

Wohlfahrt JC, Aass AM, Rønold 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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in relative attachment loss		6 months	No
Secondary	Change in probing depth		6 months	No
Secondary	Change in plaque index		6 months	No