Furcation DefectsPhase 2/3NCT02612792

Platelet Rich Fibrin+1.2% Atorvastatin in Treatment of Mandibular Degree II Furcation Defects

A Phase 2/3 study testing Open flap debridement (OFD), OFD with Platelet rich fibrin (PRF) and OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel form in people with Furcation Defects, 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 was designed to explore the effectiveness of PRF combined with 1.2% ATV gel in treatment of mandibular degree II furcation defects in comparison to PRF and open flap debridement (OFD) alone. Read more about this study

Who is it for?: Ages 30 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Furcation Defects
What is being tested?: Open flap debridement (OFD), OFD with Platelet rich fibrin (PRF) and OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel form
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteIndia
Study dates: Dec 2014to Aug 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 30 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Buccal degree II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP);
No history of antibiotic or periodontal therapy in the preceding 6 months.

Who cannot join

Aggressive periodontitis patients
Systemic conditions known to affect the periodontal status;
Medications known to affect the outcomes of periodontal therapy;
Hematological disorders and insufficient platelet count (<100,000/mm3);
Pregnancy/lactation;
Smoking and tobacco use in any form

Show all 9Show fewer

Immunocompromised individuals;
Those having unacceptable oral hygiene (plaque index [PI] >1.5).
Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II were also excluded.

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 Combined With 1.2% Atorvastatin Gel in Treatment of Mandibular Degree II Furcation Defects: a Randomized Controlled Clinical Trial

Read the detailed description

Background: A variety of regenerative materials have been tried since many years for the treatment of furcation defects. Platelet-rich fibrin (PRF), a pool reservoir of platelet concentrate with growth factors and Atorvastatin (ATV), a potent member of statin group are known to promote periodontal tissue regeneration. The aim of the present study is to explore the effectiveness of PRF combined with 1.2% ATV gel in treatment of mandibular degree II furcation defects in comparison to PRF and open flap debridement (OFD) alone.

Methods: Eighty two mandibular furcation defects were treated with either OFD alone (Group 1), OFD with PRF (Group 2), and OFD with PRF+1.2% ATV gel (Group 3).Clinical parameters like probing depth (PD), relative vertical clinical attachment level (RVCAL), relative horizontal clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index (PI) were recorded at baseline and 9 months post-operatively. The radiological assessment of bone defect fill was done at baseline and 9 months, using computer-aided software.

Conditions: Furcation Defects
Being tested: Open flap debridement (OFD), OFD with Platelet rich fibrin (PRF), OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel form
Medical subject headings: Furcation Defects

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
Open flap debridement (OFD) alone
OFD with Platelet rich fibrin (PRF)Procedure or surgery
Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement
OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel formProcedure or surgery
Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement

Study groups in NCT02612792
Study group	Role	What they receive
Group 1	Active comparator	Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect Receives: Procedure: Open flap debridement (OFD)
Group 2	Active comparator	SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect Receives: Procedure: OFD with Platelet rich fibrin (PRF)
Group 3	Active comparator	SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin for treating furcation defect Receives: Procedure: OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel form

What is being measured

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

. Radiographic bone fill assessed in percentage
assessed in percentage
Measured: baseline to 9 months

Secondary outcomes (5)

probing depth measured in mm
measured in mm
Measured: baseline to 9 months
Relative vertical attachment level measured in mm
measured in mm
Measured: baseline to 9 months
Relative horizontal attachment level measured in mm
measured in mm
Measured: baseline to 9 months
modified sulcus bleeding index
0-3 scale
Measured: baseline to 9 months
plaque index
0-3 scale
Measured: 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.

Dec 2014Aug 2015

First posted24 Nov 2015 (estimated)
Study startDec 2014
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Furcation DefectsStudies 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: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02612792
Sponsor's protocol ID: GDCRI/ACM/PG/PhD/2/2013-2014U
Status last verified: Nov 2015
First submitted: 20 Nov 2015
Last updated: 24 Nov 2015
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

RecruitingPhase 3
Treatment of Class II Mandibular Furcation Defects
Class II Furcation Defect
Recruiting
Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Grade II Furcation Defects
Injectable Platelet-Rich Fibrin, Minimally Invasive
Recruiting
Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects
Class II Furcation Defect
Recruiting
Morphological Characteristics of Mandibular Molar Furcation Involvement and Efficacy of Regenerative Surgical Treatment
Periodontitis, Periodontitis (Stage 3)
Recruiting
Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements
Periodontitis, Furcation Defects

All Furcation Defects trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Platelet Rich Fibrin Combined With 1.2% Atorvastatin Gel in Treatment of Mandibular Degree II Furcation Defects: a Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT02612792
Acronym / sponsor ID: GDCRI/ACM/PG/PhD/2/2013-2014U
Conditions: Furcation Defects
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Government Dental College and Research Institute, BangaloreUniversity, hospital or other
Study start: Dec 2014
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 24 Nov 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Group 1	Active comparator	Procedure: Open flap debridement (OFD)Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect
Group 2	Active comparator	Procedure: OFD with Platelet rich fibrin (PRF)SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect
Group 3	Active comparator	Procedure: OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel formSRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin for treating furcation defect

Who may qualify

Ages: 30 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Buccal degree II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP);
No history of antibiotic or periodontal therapy in the preceding 6 months.

Key exclusion criteria (9 listed)

Aggressive periodontitis patients
Systemic conditions known to affect the periodontal status;
Medications known to affect the outcomes of periodontal therapy;
Hematological disorders and insufficient platelet count (<100,000/mm3);
Pregnancy/lactation;

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)Open flap debridement (OFD) alone	Procedure or surgery	Group 1
OFD with Platelet rich fibrin (PRF)Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement	Procedure or surgery	Group 2
OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel formOpen flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement	Procedure or surgery	Group 3

Primary outcome

. Radiographic bone fill assessed in percentage
Time frame: baseline to 9 months
assessed in percentage

5 secondary outcomes

probing depth measured in mm
Time frame: baseline to 9 months
Relative vertical attachment level measured in mm
Time frame: baseline to 9 months
Relative horizontal attachment level measured in mm
Time frame: baseline to 9 months
modified sulcus bleeding index
Time frame: baseline to 9 months
plaque index
Time frame: 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 24 Nov 2015.

Related trials for Furcation Defects

RecruitingPhase 3
Treatment of Class II Mandibular Furcation Defects
Class II Furcation Defect
Recruiting
Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Grade II Furcation Defects
Injectable Platelet-Rich Fibrin, Minimally Invasive
Recruiting
Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects
Class II Furcation Defect
Recruiting
Morphological Characteristics of Mandibular Molar Furcation Involvement and Efficacy of Regenerative Surgical Treatment
Periodontitis, Periodontitis (Stage 3)
Recruiting
Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements
Periodontitis, Furcation Defects

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.

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 2 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 24 Nov 2015. 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?

. Radiographic bone fill assessed in percentage (time frame: 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 NCT02612792.

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 24 Nov 2015.