Clinical trial NCT02463006: Porous and Non-porous Bone Grafts in Intra-bony Periodontal Defects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Periodontal Disease
Lead sponsor: Dr. D. Y. Patil Dental College & Hospital
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in relative attachment loss
timeFrame: 6 months
Secondary outcomes:
measure: Change in probing depth
timeFrame: 6 months
measure: Change in plaque index
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.