PeriodontitisPhase 2/3NCT02512952

Treatment of Periodontal Intrabony Defects Using Autologous Platelet Rich Fibrin vs Titanium Platelet Rich Fibrin

A Phase 2/3 study testing Open flap debridement (OFD), OFD with Platelet rich fibrin (PRF) and OFD with Titanium Platelet rich fibrin (TPRF) in people with Periodontitis, run by Government Dental College and Research Institute, Bangalore at 2 sites 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

Background: To compare the effectiveness of open flap debridement (OFD) alone and OFD along with either Autologous Platelet Rich Fibrin (PRF) or Titanium Platelet Rich Fibrin (TPRF) in the treatment of intrabony defects (IBDs). Read more about this study

Who is it for?: Ages 20 to 55 years
Conditions the study is for: Periodontitis
What is being tested?: Open flap debridement (OFD), OFD with Platelet rich fibrin (PRF) and OFD with Titanium Platelet rich fibrin (TPRF)
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 2 sitesIndia
Study dates: Jun 2014to Mar 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 20 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

presence of minimum 20 permanent teeth
age group 20-55 years
radiographic evidence of periodontal IBDs
probing pocket depth (PPD) >5mm in minimum two sextants in at least three teeth
clinical attachment (CA) loss of ≥ 3mm.

Who cannot join

Systemically compromised subjects
those on medications (corticosteroids/ bisphosphonate therapy) that may interfere with wound healing
grade III tooth mobility
smokers and alcoholic subjects
pregnant and lactating mothers
subjects who underwent periodontal treatment within a period of 1 year.

Trial locations and contacts

2 sites in 1 country.

India2 sites

Government Dental College and Research Institute
Bangalore, Karnataka, 560002
The Oxford Dental College
Bangalore, Karnataka, 560068

Other trials in India

About this study

Official title: Treatment of Periodontal Intrabony Defects Using Autologous Platelet Rich Fibrin and Titanium Platelet Rich Fibrin: A Randomized Clinical Comparative Study

Materials and methods: Study was conducted on subjects reporting to the Department of Periodontics, The Oxford Dental College and Hospital, Bangalore. 38 subjects with 90 periodontal IBDs of moderate to severe periodontitis were selected and assigned to OFD alone (group I) or OFD with Autologous PRF (group II) or OFD with TPRF (group III). In each subject, a minimum number of two sextants were present with probing pocket depths (PPD) ≥5mm in at least three teeth.

Conditions: Periodontitis
Being tested: Open flap debridement (OFD), OFD with Platelet rich fibrin (PRF), OFD with Titanium Platelet rich fibrin (TPRF)
Keywords: Periodontal regeneration, Growth factors
Medical subject headings: 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 Open flap debridement (OFD)
OFD with Platelet rich fibrin (PRF)Procedure or surgery
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
OFD with Titanium Platelet rich fibrin (TPRF)Procedure or surgery
Oral prophylaxis followed by Open flap debridement (OFD) with Titanium Platelet rich fibrin (TPRF) placement into the bone defect

Study groups in NCT02512952
Study group	Role	What they receive
Group 1	Active comparator	SRP with Open flap debridement (OFD) alone for treating periodontal pocket Receives: Procedure: Open flap debridement (OFD)
Group 2	Active comparator	SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into bone defect Receives: Procedure: OFD with Platelet rich fibrin (PRF)
Group 3	Active comparator	SRP with Open flap debridement (OFD) with Titanium Platelet rich fibrin (TPRF) placement into bone defect Receives: Procedure: OFD with Titanium Platelet rich fibrin (TPRF)

What is being measured

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

defect depth reduction (DDR)
Measured: Change from baseline to 9 months
change in clinical attachment level (CAL)
Measured: Change from baseline to 9 months

Secondary outcomes (2)

change in probing pocket depths (PPD)
Measured: Change from baseline to 9 months
change in plaque index (PI)
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.

Jun 2014Mar 2015

First posted31 Jul 2015 (estimated)
Study startJun 2014
Primary completionMar 2015
Study completionMar 2015

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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02512952
Sponsor's protocol ID: 224/2013-14
Status last verified: Jul 2015
First submitted: 23 Jul 2015
Last updated: 31 Jul 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

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All Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Periodontal Intrabony Defects Using Autologous Platelet Rich Fibrin and Titanium Platelet Rich Fibrin: A Randomized Clinical Comparative Study
ClinicalTrials.gov ID: NCT02512952
Acronym / sponsor ID: 224/2013-14
Conditions: Periodontitis
Keywords: Periodontal regeneration, Growth factors
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Government Dental College and Research Institute, BangaloreUniversity, hospital or other
Collaborators: The Oxford Dental College, Hospital and Research Center, Bangalore, India
Study start: Jun 2014
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 31 Jul 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.

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)SRP with Open flap debridement (OFD) alone for treating periodontal pocket
Group 2	Active comparator	Procedure: OFD with Platelet rich fibrin (PRF)SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into bone defect
Group 3	Active comparator	Procedure: OFD with Titanium Platelet rich fibrin (TPRF)SRP with Open flap debridement (OFD) with Titanium Platelet rich fibrin (TPRF) placement into bone defect

Who may qualify

Ages: 20 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

presence of minimum 20 permanent teeth
age group 20-55 years
radiographic evidence of periodontal IBDs
probing pocket depth (PPD) >5mm in minimum two sextants in at least three teeth
clinical attachment (CA) loss of ≥ 3mm.

Key exclusion criteria (6 listed)

Systemically compromised subjects
those on medications (corticosteroids/ bisphosphonate therapy) that may interfere with wound healing
grade III tooth mobility
smokers and alcoholic subjects
pregnant and lactating mothers

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 Open flap debridement (OFD)	Procedure or surgery	Group 1
OFD with Platelet rich fibrin (PRF)Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect	Procedure or surgery	Group 2
OFD with Titanium Platelet rich fibrin (TPRF)Oral prophylaxis followed by Open flap debridement (OFD) with Titanium Platelet rich fibrin (TPRF) placement into the bone defect	Procedure or surgery	Group 3

Primary outcome

defect depth reduction (DDR)
Time frame: Change from baseline to 9 months
change in clinical attachment level (CAL)
Time frame: Change from baseline to 9 months

2 secondary outcomes

change in probing pocket depths (PPD)
Time frame: Change from baseline to 9 months
change in plaque index (PI)
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 31 Jul 2015.

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
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Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
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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.

2 sites 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 5 inclusion and 6 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 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 (DDR) (time frame: Change from baseline to 9 months). The study lists 2 primary outcomes in all. 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 NCT02512952.

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 31 Jul 2015.