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

Phase 2

Completed

• Conditions: Periodontal Disease
• Interventions: Drug: Porous variant of Bioactive Glass.; Drug: Non porous variant of Bioactive Glass.

• Registration Number: NCT02463006
• Lead Sponsor: Dr. D. Y. Patil Dental College & Hospital

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-09
• Study Completion: 2015-05
• Study First Submitted: 2015-05-29
• Status Verified: 2015-06
• Study First Submitted QC: 2015-06-02
• Last Update Submitted: 2015-06-02
• Study First Posted: 2015-06-04
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
porous bone graft group	Porous variant of Bioactive Glass.	Intervention: Flap surgery procedure with porous bone grafting (Periooglass)
Non-porous bone gaft group	Non porous variant of Bioactive Glass.	Intervention: Flap surgery procedure with non-porous bone grafting (Novabone morsels)

Primary Outcome Measures

Name	Time	Method
Change in relative attachment loss	6 months

Secondary Outcome Measures

Name	Time	Method
Change in probing depth	6 months
Change in plaque index	6 months