NCT02463006

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

8 months

First QC Date

May 29, 2015

Last Update Submit

June 2, 2015

Conditions

Periodontal Disease

Outcome Measures

Primary Outcomes (1)

  • Change in relative attachment loss

    6 months

Secondary Outcomes (2)

  • Change in probing depth

    6 months

  • Change in plaque index

    6 months

Study Arms (2)

porous bone graft group

EXPERIMENTAL

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

Drug: Porous variant of Bioactive Glass.

Non-porous bone gaft group

ACTIVE COMPARATOR

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

Drug: Non porous variant of Bioactive Glass.

Interventions

Porous variant of Bioactive Glass.DRUG

Flap surgery with Porous variant of Bioactive Glass.

porous bone graft group
Non porous variant of Bioactive Glass.DRUG

Flap surgery with non-Porous variant of Bioactive Glass.

Non-porous bone gaft group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-55 years.
  • Probing Depth \>5mm.

You may not qualify if:

  • History of periodontal treatment last six months.
  • Bleeding disorders.
  • Gross oral pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 23055593RESULT

  • 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.

    PMID: 21692628RESULT

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 29, 2015

First Posted

June 4, 2015

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

May 1, 2015

Last Updated

June 4, 2015

Record last verified: 2015-06