PeriodontitisPhase 2NCT02119520
PLATELET RICH FIBRIN COMBINED WITH 1.2% ATORVASTATIN FOR TREATMENT OF INTRABONY DEFECTS IN CHRONIC PERIODONTITIS
A Phase 2 study testing Platelet rich fibrin +Atorvastatin, Platelet rich fibrin and open flap debridement in people with Periodontitis, run by Government Dental College and Research Institute, Bangalore at 1 site in India.
Trial summary
Current study was designed to evaluate the combined efficacy of PRF and 1.2% ATV gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis subjects. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Platelet rich fibrin +Atorvastatin, Platelet rich fibrin and open flap debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2013to Feb 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- the presence of 3- wall IBD ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPA]) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing [SRP]) in asymptomatic teeth.
Who cannot join
- 1) Agressive Periodontitis subjects; 2) Systemic conditions known to affect the periodontal status; 3) medications known to affect the outcomes of periodontal therapy; 4) Hematological disorders and insufficient platelet count (<200,000/mm3); 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.
Trial locations and contacts
1 site in 1 country.
India1 site
Govt dental college and research institute
Bangalore, Karnataka, 560002
About this study
Current study was designed to evaluate the combined efficacy of PRF and 1.2% ATV gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis subjects.
- Conditions
- Periodontitis
- Being tested
- Platelet rich fibrin +Atorvastatin, Platelet rich fibrin, open flap debridement
- Keywords
- Periodontitis, Surgery, Growth Factors, Statins
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrin +AtorvastatinDrug
Platelet rich fibrinDrug
open flap debridementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich fibrin + atorvastatin | Active comparator | In Platelet rich fibrin+ATV group PRF combined with 10 µl of 1.2% ATV was inserted into the depth of the IBD Receives: Drug: Platelet rich fibrin +Atorvastatin |
| Platelet rich fibrin | Sham comparator | In Platelet rich fibrin group PRF was inserted into the depth of the IBD. Receives: Drug: Platelet rich fibrin |
| Open flap debridement | Other | open flap debridement was followed by no grafting or regenerative intervention. Receives: Procedure: open flap debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage radiographic defect depth reduction
Defect depth reduction will be assessed from baseline to 9 month post operatively on radiographs
Measured: 9 months from baseline
Secondary outcomes (5)
change in probing depth
probing depth will be assessed from gingival margin to pocket depth at baseline and 9 months postoperatively
Measured: 9 months from baseline
change in relative attachment level
RAL will be assesed from fixed point on the stent at baseline and 9 months postoperatively
Measured: 9 months from baseline
change in plaque levels
plaque levels were assessed at baseline and 9 months postoperatively
Measured: 9 months from baseline
change in gingival bleeding
gingival bleeding was assesed at baseline and 9 months postoperatively
Measured: 9 months from baseline
change in gingival margin levels
change in gingival margin levels were assesed at baseline and 9 months
Measured: 9 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 96 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, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119520
- Sponsor's protocol ID
- GDCRI/ACM/PG/PhD/2011-2012/D
- Status last verified
- Apr 2014
- First submitted
- 17 Apr 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLATELET RICH FIBRIN COMBINED WITH 1.2% ATORVASTATIN FOR TREATMENT OF INTRABONY DEFECTS IN CHRONIC PERIODONTITIS
- ClinicalTrials.gov ID
- NCT02119520
- Acronym / sponsor ID
- GDCRI/ACM/PG/PhD/2011-2012/D
- Conditions
- Periodontitis
- Keywords
- Periodontitis, Surgery, Growth Factors, Statins
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 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.
Current study was designed to evaluate the combined efficacy of PRF and 1.2% ATV gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis subjects.
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 |
|---|---|---|
| Platelet rich fibrin + atorvastatin | Active comparator | Drug: Platelet rich fibrin +AtorvastatinIn Platelet rich fibrin+ATV group PRF combined with 10 µl of 1.2% ATV was inserted into the depth of the IBD |
| Platelet rich fibrin | Sham comparator | Drug: Platelet rich fibrinIn Platelet rich fibrin group PRF was inserted into the depth of the IBD. |
| Open flap debridement | Other | Procedure: open flap debridementopen flap debridement was followed by no grafting or regenerative intervention. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- the presence of 3- wall IBD ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPA]) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing [SRP]) in asymptomatic teeth.
Key exclusion criteria (1 listed)
- 1) Agressive Periodontitis subjects; 2) Systemic conditions known to affect the periodontal status; 3) medications known to affect the outcomes of periodontal therapy; 4) Hematological disorders and insufficient platelet count (<200,000/mm3); 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.
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 +Atorvastatin | Drug | Platelet rich fibrin + atorvastatin |
| Platelet rich fibrin | Drug | Platelet rich fibrin |
| open flap debridement | Procedure or surgery | Open flap debridement |
Primary outcome
Percentage radiographic defect depth reduction
Time frame: 9 months from baseline
Defect depth reduction will be assessed from baseline to 9 month post operatively on radiographs
5 secondary outcomes
change in probing depth
Time frame: 9 months from baseline
change in relative attachment level
Time frame: 9 months from baseline
change in plaque levels
Time frame: 9 months from baseline
change in gingival bleeding
Time frame: 9 months from baseline
change in gingival margin levels
Time frame: 9 months from baseline
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 21 Apr 2014.
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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
Professor
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 +Atorvastatin, Platelet rich fibrin and open flap debridement in people with 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 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 21 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?
Percentage radiographic defect depth reduction (time frame: 9 months from baseline). 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 21 Apr 2014.