Three Wall Intrabony Defects in Chronic PeriodontitisPhase 2NCT02120872
Platelet Rich Fibrin Combined With Simvastatin for Treatment of Intrabony Defect in Chronic Periodontitis
A Phase 2 study testing Platelet rich fibrin and simvastatin, Platelet rich fibrin and Open Flap Debridement alone in people with Three Wall Intrabony Defects in Chronic Periodontitis, run by Government Dental College and Research Institute, Bangalore at 1 site in India.
Trial summary
The purpose of the present study was to investigate the efficacy of autologous Platelet rich fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment of three wall intrabony defects in comparison to OFD alone. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Three Wall Intrabony Defects in Chronic Periodontitis
- What is being tested?
- Platelet rich fibrin and simvastatin, Platelet rich fibrin and Open Flap Debridement alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2013to Jan 2014
- Phase
- Phase 2
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with the diagnosis of chronic periodontitis
- presence of three walled intrabony defects (IBD) ≥ 3 mm deep (distance between alveolar crest and base of the defect on intraoral periapical radiograph [IOPA])
- interproximal probing depth (PD) ≥ 5 mm following scaling and root planing (SRP) in asymptomatic tooth
Who cannot join
- Subjects, with the diagnosis of aggressive periodontitis,
- with known systemic illness and taking medications known to affect the outcomes of periodontal therapy
- insufficient platelet count (< 200,000/mm3),
- pregnancy / lactation
- use of any form of tobacco
- unacceptable oral hygiene (if plaque index [PI] (Silness \& Loe 1964) >1.5) after the reevaluation of phase I therapy
Show all 9Show fewer
- teeth with furcation defects
- non-vital
- mobility of tooth ≥ Grade II
Trial locations and contacts
1 site in 1 country.
India1 site
Government Dental College and Research Institute
Bangalore, Karnataka, 560002
About this study
Official title: Platelet - Rich Fibrin Combined With 1.2mg Simvastatin for the Treatment of 3 - Wall Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial
The purpose of the present study was to investigate the efficacy of autologous Platelet rich fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment of three wall intrabony defects in comparison to OFD alone.
Read the detailed description
90 systemically healthy subjects were divided randomly into three groups (30 subjects in each group, per subject one site). Control group consisted of the sites treated with OFD and test groups sites were treated with OFD with autologous PRF or PRF with SMV. Site-specific plaque index (PI), sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and intrabony defect (IBD) depth reduction was measured at baseline and 9 month after surgery.
- Being tested
- Platelet rich fibrin and simvastatin, Platelet rich fibrin, Open Flap Debridement alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrin and simvastatinDrug
Three wall intrabony defect sites treated with Open Flap Debridement. 0.1 mL prepared SMV gel (1.2 mg/0.1 mL) was mixed with PRF. The PRF - SMV mixture was delivered to the defect.
Platelet rich fibrinBiological
Three wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect.
Open Flap Debridement aloneProcedure or surgery
Three wall intrabony defect sites treated with Open Flap Debridement only. No PRF or SMV was delivered to the defect.
| Study group | Role | What they receive |
|---|---|---|
| PRF and SMV Group | Active comparator | sites treated with Open Flap Debridement with Platelet Rich Fibrin along with Simvastatin Receives: Drug: Platelet rich fibrin and simvastatin |
| PRF Group | Sham comparator | sites treated with Open Flap Debridement with autologous Platelet Rich Fibrin Receives: Biological: Platelet rich fibrin |
| OFD Group | Other | sites treated with Open Flap Debridement i.e. conventional flap surgery Receives: Procedure: Open Flap Debridement alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of the study was defect depth reduction evaluated radiographically
Measured: At baseline and 9 month after surgery
Secondary outcomes (4)
Probing Depth
Measured: At baseline and 9 month after surgery
Relative Attachment Level
Measured: At baseline and 9 month after syrgery
modified Sulcul Bleeding Index
Measured: At baseline and 9 month after surgery
Plaque Index
Measured: At baseline and 9 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startFeb 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Three Wall Intrabony Defects in Chronic PeriodontitisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Dental College and Research Institute, Bangalore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore
- Investigators
- Avani R Pradeep, MDS, Principal investigator, Government Dental College and Research Institute, Bangalore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120872
- Sponsor's protocol ID
- GDCRI/ACM/PG/PhD/2011-2012/E
- Status last verified
- Apr 2014
- First submitted
- 17 Apr 2014
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet - Rich Fibrin Combined With 1.2mg Simvastatin for the Treatment of 3 - Wall Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02120872
- Acronym / sponsor ID
- GDCRI/ACM/PG/PhD/2011-2012/E
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 Apr 2014 (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.
The purpose of the present study was to investigate the efficacy of autologous Platelet rich fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment of three wall intrabony defects in comparison to OFD alone.
Detailed description
90 systemically healthy subjects were divided randomly into three groups (30 subjects in each group, per subject one site). Control group consisted of the sites treated with OFD and test groups sites were treated with OFD with autologous PRF or PRF with SMV. Site-specific plaque index (PI), sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and intrabony defect (IBD) depth reduction was measured at baseline and 9 month after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRF and SMV Group | Active comparator | Drug: Platelet rich fibrin and simvastatinsites treated with Open Flap Debridement with Platelet Rich Fibrin along with Simvastatin |
| PRF Group | Sham comparator | Biological: Platelet rich fibrinsites treated with Open Flap Debridement with autologous Platelet Rich Fibrin |
| OFD Group | Other | Procedure: Open Flap Debridement alonesites treated with Open Flap Debridement i.e. conventional flap surgery |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects with the diagnosis of chronic periodontitis
- presence of three walled intrabony defects (IBD) ≥ 3 mm deep (distance between alveolar crest and base of the defect on intraoral periapical radiograph [IOPA])
- interproximal probing depth (PD) ≥ 5 mm following scaling and root planing (SRP) in asymptomatic tooth
Key exclusion criteria (9 listed)
- Subjects, with the diagnosis of aggressive periodontitis,
- with known systemic illness and taking medications known to affect the outcomes of periodontal therapy
- insufficient platelet count (< 200,000/mm3),
- pregnancy / lactation
- use of any form of tobacco
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 |
|---|---|---|
| Platelet rich fibrin and simvastatinThree wall intrabony defect sites treated with Open Flap Debridement. 0.1 mL prepared SMV gel (1.2 mg/0.1 mL) was mixed with PRF. The PRF - SMV mixture was delivered to the defect. | Drug | PRF and SMV Group |
| Platelet rich fibrinThree wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect. | Biological | PRF Group |
| Open Flap Debridement aloneThree wall intrabony defect sites treated with Open Flap Debridement only. No PRF or SMV was delivered to the defect. | Procedure or surgery | OFD Group |
Primary outcome
The primary outcome measure of the study was defect depth reduction evaluated radiographically
Time frame: At baseline and 9 month after surgery
4 secondary outcomes
Probing Depth
Time frame: At baseline and 9 month after surgery
Relative Attachment Level
Time frame: At baseline and 9 month after syrgery
modified Sulcul Bleeding Index
Time frame: At baseline and 9 month after surgery
Plaque Index
Time frame: At baseline and 9 month after 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 23 Apr 2014.
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.
Avani R Pradeep, MDS principal investigator
Government Dental College and Research Institute, Bangalore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Platelet rich fibrin and simvastatin, Platelet rich fibrin and Open Flap Debridement alone in people with Three Wall Intrabony Defects in Chronic Periodontitis, run by Government Dental College and Research Institute, Bangalore 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 3 inclusion and 9 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 23 Apr 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
The primary outcome measure of the study was defect depth reduction evaluated radiographically (time frame: At baseline and 9 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2014.