Periodontal DiseasePhase 2/3NCT02463006
Porous and Non-porous Bone Grafts in Intra-bony Periodontal Defects
A Phase 2/3 study testing Porous variant of Bioactive Glass. and Non porous variant of Bioactive Glass. in people with Periodontal Disease, run by Dr. D. Y. Patil Dental College & Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- Porous variant of Bioactive Glass. and Non porous variant of Bioactive Glass.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to May 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-55 years.
- Probing Depth >5mm.
Who cannot join
- History of periodontal treatment last six months.
- Bleeding disorders.
- Gross oral pathology.
About this study
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
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.
Read the detailed description
OBJECTIVES:
- To evaluate clinically the periodontal healing with Porous variant of Bioactive Glass placed in the intra bony defects at an interval of 6 months.
- 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.
- 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.
- 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.
- 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.
- 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
- Being tested
- Porous variant of Bioactive Glass., Non porous variant of Bioactive Glass.
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Porous variant of Bioactive Glass.Drug
Flap surgery with Porous variant of Bioactive Glass.
Non porous variant of Bioactive Glass.Drug
Flap surgery with non-Porous variant of Bioactive Glass.
| Study group | Role | What they receive |
|---|---|---|
| porous bone graft group | Experimental | Intervention: Flap surgery procedure with porous bone grafting (Periooglass) Receives: Drug: Porous variant of Bioactive Glass. |
| Non-porous bone gaft group | Active comparator | Intervention: Flap surgery procedure with non-porous bone grafting (Novabone morsels) Receives: Drug: Non porous variant of Bioactive Glass. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in relative attachment loss
Measured: 6 months
Secondary outcomes (2)
Change in probing depth
Measured: 6 months
Change in plaque index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionSep 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. D. Y. Patil Dental College & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D. Gopalakrishnan, Dr. D. Y. Patil Dental College & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463006
- Sponsor's protocol ID
- DYPDCH/12/PG16
- Status last verified
- Jun 2015
- First submitted
- 29 May 2015
- Last updated
- 4 Jun 2015
- Results posted
- No
Publications
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.
PubMed 23055593Wohlfahrt 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.
PubMed 21692628
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02463006
- Acronym / sponsor ID
- DYPDCH/12/PG16
- Conditions
- Periodontal Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dr. D. Y. Patil Dental College & HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate clinically the periodontal healing with Porous variant of Bioactive Glass placed in the intra bony defects at an interval of 6 months.
- 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.
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| porous bone graft group | Experimental | Drug: Porous variant of Bioactive Glass.Intervention: Flap surgery procedure with porous bone grafting (Periooglass) |
| Non-porous bone gaft group | Active comparator | Drug: Non porous variant of Bioactive Glass.Intervention: Flap surgery procedure with non-porous bone grafting (Novabone morsels) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Porous variant of Bioactive Glass.Flap surgery with Porous variant of Bioactive Glass. | Drug | porous bone graft group |
| Non porous variant of Bioactive Glass.Flap surgery with non-Porous variant of Bioactive Glass. | Drug | Non-porous bone gaft group |
Primary outcome
Change in relative attachment loss
Time frame: 6 months
2 secondary outcomes
Change in probing depth
Time frame: 6 months
Change in plaque index
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Results publication: PubMed 23055593Gokhale 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.
- Results publication: PubMed 21692628Wohlfahrt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Porous variant of Bioactive Glass. and Non porous variant of Bioactive Glass. in people with Periodontal Disease, run by Dr. D. Y. Patil Dental College & Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in relative attachment loss (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02463006, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.