PeriodontitisPhase 2NCT02283554
Platelet Rich Fibrin With 1% Metformin Gel for Treatment of Intrabony Defects
A Phase 2 study testing open flap debridement (OFD), Platelet rich fibrin (PRF) and Metformin in people with Periodontitis, run by Government Dental College and Research Institute, Bangalore.
Trial summary
ABSTRACT: Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Metformin (MF), a member of biguanide group has been shown to facilitate osteoblast differentiation and thus may exhibit a favourable effect on alveolar… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- open flap debridement (OFD), Platelet rich fibrin (PRF) and Metformin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jul 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of 3- wall intrabony defects ≥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 molar teeth.
Who cannot join
- Aggressive Periodontitis subjects
- Subjects with systemic conditions known to affect the periodontal status
- Medications known to affect the outcomes of periodontal therapy
- Hematological disorders and insufficient platelet count (<200,000/mm3)
- Pregnancy/lactation
- Smoking and tobacco use in any form
- Immunocompromised individuals. Those having unacceptable oral hygiene (plaque index [PI]16 > 1.5) after re-evaluation of Phase I therapy were also excluded from the study.
- In addition, teeth with furcation defects, non vital teeth, carious teeth warranting restorations and mobility of at least grade II were also excluded.
About this study
Official title: Platelet Rich Fibrin With 1% Metformin for the Treatment of Intrabony Defects in Chronic Periodontitis : A Randomized Controlled Clinical Trial
ABSTRACT:
Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Metformin (MF), a member of biguanide group has been shown to facilitate osteoblast differentiation and thus may exhibit a favourable effect on alveolar bone . Current study was designed to evaluate the combined efficacy of PRF and 1% MF gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis (CP) subjects.
Methods: One hundred and twenty subjects with single defects were categorized into four treatment groups: OFD alone, OFD with PRF, OFD with 1% MF and OFD + PRF+1% MF. Clinical parameters like site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and gingival marginal level (GML) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic intra-bony defect depth reduction was evaluated using computer-aided software at baseline and 9 months.
- Conditions
- Periodontitis
- Being tested
- open flap debridement (OFD), Platelet rich fibrin (PRF), Metformin
- Keywords
- Periodontal Surgery, Periodontal Regeneration, Growth factors, Clinical trials
- 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
Platelet rich fibrin (PRF)Other
MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| ARM1- open flap debridement (OFD) | Placebo comparator | open flap debridement done for 30 subjects. After debridement, Metformin or PRF was not added into the intrabony defect. Receives: Procedure: open flap debridement (OFD) |
| ARM2- open flap debridement plus PRF(Platelet rich fibrin) | Experimental | After open flap debridement, PRF( Platelet rich fibrin) was added into the intrabony defect.
No. of subjects= 30 Receives: Procedure: open flap debridement (OFD); Other: Platelet rich fibrin (PRF) |
| ARM3- open flap debridement plus 1%Metformin | Experimental | After open flap debridement, 1% metformin was added into the intrabony defect No. of subjects= 30 Receives: Procedure: open flap debridement (OFD); Drug: Metformin |
| ARM4- open flap debridement plus PRF plus metformin | Experimental | After open flap debridement, PRF and 1% metformin was added into the intrabony defect.
No. of subject- 30 Receives: Procedure: open flap debridement (OFD); Other: Platelet rich fibrin (PRF); Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic defect depth reduction from baseline to 9 months.
The primary outcome of the study was radiographic defect depth reduction from baseline to 9 months
Measured: radiographic defect depth reduction from baseline to 9 months.
Secondary outcomes (5)
Change in PD
PD at 3,6 and 9 months was evaluated by using a UNC-15 probe from the gingival margin to the base of pockrt
Measured: Assessment of PD at 3,6 and 9 months
Change in RAL
RAL is measured by measuring the distance between apical level of customized acrylic stent to pocket base
Measured: Assessment of RAL at 3,6 and 9 months
Change in GML
Assessment of GML is done from apical level of customized acrylic stent, using a UNC 15 periodontal probe
Measured: Assessment of GML at 3,6 and 9 months
Change in mSBI
mSBI is assessed by noting the amount of bleeding after probing, at 3,6 and 9 months
Measured: Assessment of mSBI at 3,6 and 9 months
Cgange in PI
PI is assessed by noting the amount of plaque and the site of plaque present on the tooth surface at 3,6 and 9 months
Measured: Assessment of PI at 3,6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startNov 2013
- Primary completionJul 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283554
- Sponsor's protocol ID
- GDCRI/ACM/PG/PhD/2/2013-2014B
- Status last verified
- Nov 2014
- First submitted
- 27 Sep 2014
- Last updated
- 5 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Fibrin With 1% Metformin for the Treatment of Intrabony Defects in Chronic Periodontitis : A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02283554
- Acronym / sponsor ID
- GDCRI/ACM/PG/PhD/2/2013-2014B
- Conditions
- Periodontitis
- Keywords
- Periodontal Surgery, Periodontal Regeneration, Growth factors, Clinical trials
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2014 (actual)
- First posted
- 5 Nov 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.
ABSTRACT:
Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Metformin (MF), a member of biguanide group has been shown to facilitate osteoblast differentiation and thus may exhibit a favourable effect on alveolar bone . Current study was designed to evaluate the combined efficacy of PRF and 1% MF gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis (CP) subjects.
Methods: One hundred and twenty subjects with single defects were categorized into four treatment groups: OFD alone, OFD with PRF, OFD with 1% MF and OFD + PRF+1% MF. Clinical parameters like site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and gingival marginal level (GML) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic intra-bony defect depth reduction was evaluated using computer-aided software at baseline and 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ARM1- open flap debridement (OFD) | Placebo comparator | Procedure: open flap debridement (OFD)open flap debridement done for 30 subjects. After debridement, Metformin or PRF was not added into the intrabony defect. |
| ARM2- open flap debridement plus PRF(Platelet rich fibrin) | Experimental | Procedure: open flap debridement (OFD), Other: Platelet rich fibrin (PRF)After open flap debridement, PRF( Platelet rich fibrin) was added into the intrabony defect. No. of subjects= 30 |
| ARM3- open flap debridement plus 1%Metformin | Experimental | Procedure: open flap debridement (OFD), Drug: MetforminAfter open flap debridement, 1% metformin was added into the intrabony defect No. of subjects= 30 |
| ARM4- open flap debridement plus PRF plus metformin | Experimental | Procedure: open flap debridement (OFD), Other: Platelet rich fibrin (PRF), Drug: MetforminAfter open flap debridement, PRF and 1% metformin was added into the intrabony defect. No. of subject- 30 |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Presence of 3- wall intrabony defects ≥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 molar teeth.
Key exclusion criteria (8 listed)
- Aggressive Periodontitis subjects
- Subjects with systemic conditions known to affect the periodontal status
- Medications known to affect the outcomes of periodontal therapy
- Hematological disorders and insufficient platelet count (<200,000/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) | Procedure or surgery | ARM1- open flap debridement (OFD), ARM2- open flap debridement plus PRF(Platelet rich fibrin), ARM3- open flap debridement plus 1%Metformin, ARM4- open flap debridement plus PRF plus metformin |
| Platelet rich fibrin (PRF) | Other | ARM2- open flap debridement plus PRF(Platelet rich fibrin), ARM4- open flap debridement plus PRF plus metformin |
| Metformin | Drug | ARM3- open flap debridement plus 1%Metformin, ARM4- open flap debridement plus PRF plus metformin |
Primary outcome
radiographic defect depth reduction from baseline to 9 months.
Time frame: radiographic defect depth reduction from baseline to 9 months.
The primary outcome of the study was radiographic defect depth reduction from baseline to 9 months
5 secondary outcomes
Change in PD
Time frame: Assessment of PD at 3,6 and 9 months
Change in RAL
Time frame: Assessment of RAL at 3,6 and 9 months
Change in GML
Time frame: Assessment of GML at 3,6 and 9 months
Change in mSBI
Time frame: Assessment of mSBI at 3,6 and 9 months
Cgange in PI
Time frame: Assessment of PI at 3,6 and 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 Nov 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing open flap debridement (OFD), Platelet rich fibrin (PRF) and Metformin in people with Periodontitis, run by Government Dental College and Research Institute, Bangalore.
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 8 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 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
radiographic defect depth reduction from baseline to 9 months. (time frame: radiographic defect depth reduction 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?
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 Nov 2014.