Intrabony Periodontal DefectCBBSGPPOPIDWDNCT03651908
Comparison Between Bioactive Silica Graft Plus Platelet Rich Fibrin and Only Platelet Rich Fibrin Graft in Intrabony Defects With Diabetes
A study testing Conventional Flap Surgery in people with Intrabony Periodontal Defect, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
Trial summary
Various regenerative procedures used for the treatment of intabony defects.The Aim of this study is to compare the treatment outcome of bioactive silica graft with platelet rich fibrin Vs bioactive silica graft in the treatment of intrabony defects in patients with diabetes mellitus. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- Conventional Flap Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIndia
- Study dates
- 5 Sep 2017to 30 Sep 2018
- Phase
- Interventional
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Two or three walled defects With relative clinical attachment loss ≥3mm Probing depth≥5mm Patients with known diabetes(Type 2 hbA1c 6 to 7.4)
Who cannot join
- One wall defects Other systemically compromised patients Non- compliant patients Individuals allergic to medication Pregnant or lactating mothers Smokers
Trial locations and contacts
1 site in 1 country.
India1 site
Panineya institute of dental sciences and research center
Hyderabad, Telangana, 500060
About this study
Official title: Evaluation of Efficacy of Bioactive Silica Graft With Platelet Rich Fibrin Vs Bioactive Silica Graft Alone In The Treatment Of Intrabony Defects In Patients With Type II Diabetes Mellitus -A Randomized Clinical Study.
Various regenerative procedures used for the treatment of intabony defects.The Aim of this study is to compare the treatment outcome of bioactive silica graft with platelet rich fibrin Vs bioactive silica graft in the treatment of intrabony defects in patients with diabetes mellitus.
Read the detailed description
Platelet rich fibrin has emerged as one of the promising regenerative material.It is a second generation platelet concentrate and is defined as an autologous leucocyte-and platelet-rich fibrin biomaterial.Platelet-rich fibrin membrane consists of a fibrin 3-D polymerized matrix in a specific structure ,with the incorporation of almost all the platelets and more than half of leucocytes along with growth factors.It enhance the stabilization and revascularization of the flaps and grafts.
Bioactive silica graft (Novabone dental putty )is being used for regenerative procedures is a premixed composite of bioactive calcium -phospho-silicate particulate which is composed solely of elements that exist naturally in normal bone (ca,p,na,si,o) and an absorbable binder which is a combination of polyethylene glycol and glycerine.Treatment of intrabony defects with bioactive silica graft has led to clinically and statistically significant probing depth reduction ,relative attachment level gain and radiographic osseous defect fill.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- Conventional Flap Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Flap SurgeryProcedure or surgery
After administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back.
After administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Interventional The Group A subjects will be treated with conventional flap surgery.After reflection of the full thickness flap,the intrabony defects will be debrided and Bioactive silicate graft mixed with PRF will be used as graft material to fill the defects. Receives: Procedure: Conventional Flap Surgery |
| Interventional comparator | Active comparator | Group B patients will also be treated by conventional flap surgery,employing a full thickness flap technique.The intrabony defects will be filled with Bioactive silicate only. Receives: Procedure: Conventional Flap Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic parameters - Change in bone level
Amount of bone fill in the intrabony defect (Change in bone level) to be measured by Cone Beam Computed Tomography (CBCT)
Measured: Baseline and 9 months post surgery.
Secondary outcomes (1)
clinical parameters - Changes in relative clinical attachment level
Changes in relative clinical attachment level will be measured by UNC -15 probe in millimeters in the intrabony defect area
Measured: Baseline and 9 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start5 Sep 2017
- Primary completion23 Sep 2018
- Study completion30 Sep 2018
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 Intrabony Periodontal DefectStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study the patients are divided into two test groups-group A, group B. Each patient will be given careful instructions on proper oral hygiene measures. Under local anesthesia full-mouth supragingival and subgingival scaling and root planning procedure will be performed. After therapy, a periodontal evaluation will be done and the selected sites will be divided into group A and group B. The Group A subjects will be treated with conventional flap surgery using Bioactive silica graft with PRF as a graft. Group B will be treated with conventional flap surgery +bioactive silica graft alone in intrabony defects.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. V. Sravanthi, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- Veerendra nath Reddy, MDS, Study director, Panineeya institute of dental sciences and research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651908
- Sponsor's protocol ID
- sravanthinovabone
- Acronym
- CBBSGPPOPIDWD
- Status last verified
- Jan 2019
- First submitted
- 23 Aug 2018
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grover V, Kapoor A, Malhotra R, Uppal RS. Evaluation of the efficacy of a bioactive synthetic graft material in the treatment of intrabony periodontal defects. J Indian Soc Periodontol. 2013 Jan;17(1):104-10. doi: 10.4103/0972-124X.107484.
PubMed 23633783Sharma A, Pradeep AR. Treatment of 3-wall intrabony defects in patients with chronic periodontitis with autologous platelet-rich fibrin: a randomized controlled clinical trial. J Periodontol. 2011 Dec;82(12):1705-12. doi: 10.1902/jop.2011.110075. Epub 2011 Apr 5.
PubMed 21513477
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Bioactive Silica Graft With Platelet Rich Fibrin Vs Bioactive Silica Graft Alone In The Treatment Of Intrabony Defects In Patients With Type II Diabetes Mellitus -A Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT03651908
- Acronym / sponsor ID
- CBBSGPPOPIDWD / sravanthinovabone
- Conditions
- Intrabony Periodontal Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 23 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 29 Aug 2018 (actual)
- 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.
Various regenerative procedures used for the treatment of intabony defects.The Aim of this study is to compare the treatment outcome of bioactive silica graft with platelet rich fibrin Vs bioactive silica graft in the treatment of intrabony defects in patients with diabetes mellitus.
Detailed description
Platelet rich fibrin has emerged as one of the promising regenerative material.It is a second generation platelet concentrate and is defined as an autologous leucocyte-and platelet-rich fibrin biomaterial.Platelet-rich fibrin membrane consists of a fibrin 3-D polymerized matrix in a specific structure ,with the incorporation of almost all the platelets and more than half of leucocytes along with growth factors.It enhance the stabilization and revascularization of the flaps and grafts.
Bioactive silica graft (Novabone dental putty )is being used for regenerative procedures is a premixed composite of bioactive calcium -phospho-silicate particulate which is composed solely of elements that exist naturally in normal bone (ca,p,na,si,o) and an absorbable binder which is a combination of polyethylene glycol and glycerine.Treatment of intrabony defects with bioactive silica graft has led to clinically and statistically significant probing depth reduction ,relative attachment level gain and radiographic osseous defect fill.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In this study the patients are divided into two test groups-group A, group B. Each patient will be given careful instructions on proper oral hygiene measures. Under local anesthesia full-mouth supragingival and subgingival scaling and root planning procedure will be performed. After therapy, a periodontal evaluation will be done and the selected sites will be divided into group A and group B. The Group A subjects will be treated with conventional flap surgery using Bioactive silica graft with PRF as a graft. Group B will be treated with conventional flap surgery +bioactive silica graft alone in intrabony defects.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Procedure: Conventional Flap SurgeryInterventional The Group A subjects will be treated with conventional flap surgery.After reflection of the full thickness flap,the intrabony defects will be debrided and Bioactive silicate graft mixed with PRF will be used as graft material to fill the defects. |
| Interventional comparator | Active comparator | Procedure: Conventional Flap SurgeryGroup B patients will also be treated by conventional flap surgery,employing a full thickness flap technique.The intrabony defects will be filled with Bioactive silicate only. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Two or three walled defects With relative clinical attachment loss ≥3mm Probing depth≥5mm Patients with known diabetes(Type 2 hbA1c 6 to 7.4)
Key exclusion criteria (1 listed)
- One wall defects Other systemically compromised patients Non- compliant patients Individuals allergic to medication Pregnant or lactating mothers Smokers
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 |
|---|---|---|
| Conventional Flap SurgeryAfter administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back. After administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back. | Procedure or surgery | Interventional, Interventional comparator |
Primary outcome
Radiographic parameters - Change in bone level
Time frame: Baseline and 9 months post surgery.
Amount of bone fill in the intrabony defect (Change in bone level) to be measured by Cone Beam Computed Tomography (CBCT)
1 secondary outcome
clinical parameters - Changes in relative clinical attachment level
Time frame: Baseline and 9 months post surgery
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 25 Jan 2019.
- Results publication: PubMed 23633783Grover V, Kapoor A, Malhotra R, Uppal RS. Evaluation of the efficacy of a bioactive synthetic graft material in the treatment of intrabony periodontal defects. J Indian Soc Periodontol. 2013 Jan;17(1):104-10. doi: 10.4103/0972-124X.107484.
- Results publication: PubMed 21513477Sharma A, Pradeep AR. Treatment of 3-wall intrabony defects in patients with chronic periodontitis with autologous platelet-rich fibrin: a randomized controlled clinical trial. J Periodontol. 2011 Dec;82(12):1705-12. doi: 10.1902/jop.2011.110075. Epub 2011 Apr 5.
- Individual participant dataSharing planned: No
Related trials for Intrabony Periodontal Defect
Recruiting
A Closed Surgical Technique vs Modified Papilla Preservation Technique
Intrabony Periodontal Defect, Treatment
Recruiting
Treating Intrabony Defect With MINST VS MINST Extended PRF
Periodontal Intrabony Defects
Recruiting
Treatment of Intrabony Defects With Injectable Platelet-Rich Fibrin and Xenogenic Grafts
Periodontitis, Intrabony Periodontal Defect
Not yet recruiting
Alb-PRF as an Adjunct to Regenerative Periodontal Surgery
Periodontitis, Periodontitis Stage III
Recruiting
Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
Guided Tissue Regeneration, Periodontal / Methods, Dental Enamel Proteins* / Therapeutic Use
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.
Veerendra nath Reddy, MDS study director
Panineeya institute of dental sciences and research center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Flap Surgery in people with Intrabony Periodontal Defect, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
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 1 inclusion and 1 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 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Radiographic parameters - Change in bone level (time frame: Baseline and 9 months post surgery.). 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 NCT03651908, 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 25 Jan 2019.