Chronic PeriodontitisPhase 2/3NCT02645227

Platelet-rich Fibrin With 1.2% Rosuvastatin in Chronic Periodontitis Treatment

A Phase 2/3 study testing Open flap debridement (OFD), OFD with Platelet rich fibrin (PRF) and OFD with PRF and 1.2% Rosuvastatin in people with Chronic Periodontitis, run by Government Dental College and Research Institute, Bangalore at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF) and 1.2% Rosuvastatin (RSV) with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients Read more about this study

Who is it for?: Ages 25 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Periodontitis
What is being tested?: Open flap debridement (OFD), OFD with Platelet rich fibrin (PRF) and OFD with PRF and 1.2% Rosuvastatin
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteIndia
Study dates: Jan 2015to Oct 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 25 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Systemically healthy with CP diagnosis16 having probing depth (PD) ≥5mm, clinical attachment (CA) level ≥3mm and vertical bone loss ≥3mm on intraoral periapical radiographs (IOPAR) without any antibiotic or periodontal therapy in the last 6 months.

Who cannot join

History of statin allergy, statin therapy, any systemic condition or medication altering the periodontal condition, immune-compromised state, hematologic disorders, insufﬁcient platelet count (<200,000/mm3), aggressive periodontitis, substance/tobacco abuse and lactating and pregnant females.

Trial locations and contacts

1 site in 1 country.

India1 site

Government Dental College and Research Institute
Bangalore, Karnataka, 560002

Other trials in India

About this study

Official title: Platelet-rich Fibrin With 1.2% Rosuvastatin for the Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial

Read the detailed description

ABSTRACT Background: Regenerative periodontal therapy encompasses the use of various bioactive agents that are not only inflammo-modulatory but also osteoclast-inhibitory or rather, osteostimulative. The hypolipidaemic Statin group of drugs, particularly Rosuvastatin (RSV), are known to be associated with alveolar bone formation and periodontal improvements. Platelet analogues like Platelet rich fibrin (PRF), being rich sources of growth factors, have also come into widespread periodontal regenerative use. The aim of the study is to evaluate and compare the efficacy of open-ﬂap debridement (OFD) with or without PRF or PRF + 1.2% RSV gel in the treatment of intrabony defects (IBDs) in chronic periodontitis (CP) patients.

Methods: Ninety individuals with a total of 90 IBDs were randomly assigned to one of the 3 treatment groups: 1) OFD alone, 2) OFD + PRF and 3) OFD + PRF + 1.2% RSV gel placement. Plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment (CA) level and IBD depth were recorded at baseline and at 9 months post-operatively.

Conditions: Chronic Periodontitis
Being tested: Open flap debridement (OFD), OFD with Platelet rich fibrin (PRF), OFD with PRF and 1.2% Rosuvastatin
Medical subject headings: Chronic Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Open flap debridement (OFD)Procedure or surgery
Oral prophylaxis followed by OFD for treating bone defect
OFD with Platelet rich fibrin (PRF)Procedure or surgery
Oral prophylaxis followed by OFD with PRF placement into the bone defect
OFD with PRF and 1.2% RosuvastatinProcedure or surgery
Oral prophylaxis followed by OFD with PRF and 1.2% Rosuvastatin placement into the bone defect

Study groups in NCT02645227
Study group	Role	What they receive
Group 1	Active comparator	Open flap debridement (OFD) Receives: Procedure: Open flap debridement (OFD)
Group 2	Active comparator	OFD with Platelet rich fibrin (PRF) Receives: Procedure: OFD with Platelet rich fibrin (PRF)
Group 3	Active comparator	OFD with PRF and 1.2% Rosuvastatin Receives: Procedure: OFD with PRF and 1.2% Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

defect depth reduction (%)
assessed in percentage
Measured: Change from baseline to 9 months

Secondary outcomes (4)

probing depth (mm)
measured in mm
Measured: Change from baseline to 9 months
clinical attachment level (mm)
measured in mm
Measured: Change from baseline to 9 months
modified sulcus bleeding index
scale from 0-3
Measured: Change from baseline to 9 months
plaque index
scale from 0-3
Measured: Change from baseline to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Oct 2015

First posted1 Jan 2016 (estimated)
Study startJan 2015
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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 2/3
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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02645227
Sponsor's protocol ID: GDCRI/ACM/PG/PhD/12/2013-14V
Status last verified: Jan 2016
First submitted: 28 Dec 2015
Last updated: 5 Jan 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis

All Chronic Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Platelet-rich Fibrin With 1.2% Rosuvastatin for the Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT02645227
Acronym / sponsor ID: GDCRI/ACM/PG/PhD/12/2013-14V
Conditions: Chronic Periodontitis
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Government Dental College and Research Institute, BangaloreUniversity, hospital or other
Study start: Jan 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 1 Jan 2016 (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.

Detailed description

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
Group 1	Active comparator	Procedure: Open flap debridement (OFD)Open flap debridement (OFD)
Group 2	Active comparator	Procedure: OFD with Platelet rich fibrin (PRF)OFD with Platelet rich fibrin (PRF)
Group 3	Active comparator	Procedure: OFD with PRF and 1.2% RosuvastatinOFD with PRF and 1.2% Rosuvastatin

Who may qualify

Ages: 25 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Systemically healthy with CP diagnosis16 having probing depth (PD) ≥5mm, clinical attachment (CA) level ≥3mm and vertical bone loss ≥3mm on intraoral periapical radiographs (IOPAR) without any antibiotic or periodontal therapy in the last 6 months.

Key exclusion criteria (1 listed)

History of statin allergy, statin therapy, any systemic condition or medication altering the periodontal condition, immune-compromised state, hematologic disorders, insufﬁcient platelet count (<200,000/mm3), aggressive periodontitis, substance/tobacco abuse and lactating and pregnant females.

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
Open flap debridement (OFD)Oral prophylaxis followed by OFD for treating bone defect	Procedure or surgery	Group 1
OFD with Platelet rich fibrin (PRF)Oral prophylaxis followed by OFD with PRF placement into the bone defect	Procedure or surgery	Group 2
OFD with PRF and 1.2% RosuvastatinOral prophylaxis followed by OFD with PRF and 1.2% Rosuvastatin placement into the bone defect	Procedure or surgery	Group 3

Primary outcome

defect depth reduction (%)
Time frame: Change from baseline to 9 months
assessed in percentage

4 secondary outcomes

probing depth (mm)
Time frame: Change from baseline to 9 months
clinical attachment level (mm)
Time frame: Change from baseline to 9 months
modified sulcus bleeding index
Time frame: Change from baseline to 9 months
plaque index
Time frame: Change from baseline to 9 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 5 Jan 2016.

Related trials for Chronic Periodontitis

Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis

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 Pradeep, MDS study director

Government Dental Colleege & Research Institute, Bangalore

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 Jan 2016. 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.

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?

defect depth reduction (%) (time frame: Change from baseline to 9 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 NCT02645227.

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 5 Jan 2016.