Chronic PeriodontitisPhase 2/3NCT02516111
Comparison of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Chronic Periodontitis Treatment
A Phase 2/3 study testing Open flap debridement (OFD), OFD with PRF and OFD with ALN in people with Chronic Periodontitis, run by Government Dental College and Research Institute, Bangalore.
Trial summary
The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2% atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Open flap debridement (OFD), OFD with PRF and OFD with ALN
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to May 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included
Who cannot join
- Patients with a known systemic disease
- Known or suspected allergy to the ALN/ bisphosphonates or ATV/statin group
- On systemic ALN/ bisphosphonates or ATV/statin group
- With aggressive periodontitis
- Who used tobacco in any form
- Alcoholics
- Immunocompromised patients
- And pregnant or lactating females were excluded from the study
About this study
Official title: Comparative Evaluation of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Treatment of 2/3-walled Intrabony Defects in Chronic Periodontitis Subjects: a Randomized Controlled Clinical Trial
The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2% atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.
Read the detailed description
Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of autologous PRF, 1% alendronate and 1.2% atorvastatin gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.
Methods: 120 CP subjects with IBD ≥3 mm deep and probing depth (PD) ≥5 mm, following scaling and root planing (SRP), were categorized into four treatment groups: 1) OFD 2) OFD with PRF 3) OFD with 1% ALN gel and 4) OFD with 1.2% ATV gel. Clinical parameters including site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD) and relative attachment level (RAL) as well as percentage radiographic intrabony defect depth reduction (DDR) were recorded at baseline before surgery and 9 months post-operatively.
- Conditions
- Chronic Periodontitis
- Being tested
- Open flap debridement (OFD), OFD with PRF, OFD with ALN, OFD with ATV
- 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 Open flap debridement (OFD)
OFD with PRFBiological
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
OFD with ALNDrug
Oral prophylaxis followed by Open flap debridement (OFD) with 1% ALN gel placement into the bone defect
OFD with ATVDrug
Oral prophylaxis followed by Open flap debridement (OFD) with 1.2% ATV gel placement into the bone defect
| Study group | Role | What they receive |
|---|---|---|
| Open flap debridement group | Active comparator | SRP with Open flap debridement (OFD) alone for treating intrabony defect Receives: Procedure: Open flap debridement (OFD) |
| PRF group | Active comparator | SRP with Open flap debridement (OFD) with autologous Platelet rich fibrin (PRF) placement into intrabony defect Receives: Biological: OFD with PRF |
| Alendronate group | Active comparator | SRP with Open flap debridement (OFD) with 1% Alendronate (ALN) placement into intrabony defect Receives: Drug: OFD with ALN |
| Atorvastatin group | Active comparator | SRP with Open flap debridement (OFD) with 1.2% Atorvastatin (ATV) placement into intrabony defect Receives: Drug: OFD with ATV |
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
Secondary outcomes (3)
change in clinical attachment level (CAL)
Measured: Change from baseline to 9 months
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.
- First posted5 Aug 2015 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 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
- 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
- NCT02516111
- Sponsor's protocol ID
- GDCRI/ACM/PG/PhD/2/2013-2014M
- Status last verified
- Aug 2015
- First submitted
- 3 Aug 2015
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Treatment of 2/3-walled Intrabony Defects in Chronic Periodontitis Subjects: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02516111
- Acronym / sponsor ID
- GDCRI/ACM/PG/PhD/2/2013-2014M
- Conditions
- Chronic Periodontitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 5 Aug 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.
The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2% atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.
Detailed description
Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of autologous PRF, 1% alendronate and 1.2% atorvastatin gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.
Methods: 120 CP subjects with IBD ≥3 mm deep and probing depth (PD) ≥5 mm, following scaling and root planing (SRP), were categorized into four treatment groups: 1) OFD 2) OFD with PRF 3) OFD with 1% ALN gel and 4) OFD with 1.2% ATV gel. Clinical parameters including site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD) and relative attachment level (RAL) as well as percentage radiographic intrabony defect depth reduction (DDR) were recorded at baseline before surgery and 9 months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Open flap debridement group | Active comparator | Procedure: Open flap debridement (OFD)SRP with Open flap debridement (OFD) alone for treating intrabony defect |
| PRF group | Active comparator | Biological: OFD with PRFSRP with Open flap debridement (OFD) with autologous Platelet rich fibrin (PRF) placement into intrabony defect |
| Alendronate group | Active comparator | Drug: OFD with ALNSRP with Open flap debridement (OFD) with 1% Alendronate (ALN) placement into intrabony defect |
| Atorvastatin group | Active comparator | Drug: OFD with ATVSRP with Open flap debridement (OFD) with 1.2% Atorvastatin (ATV) placement into intrabony defect |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included
Key exclusion criteria (8 listed)
- Patients with a known systemic disease
- Known or suspected allergy to the ALN/ bisphosphonates or ATV/statin group
- On systemic ALN/ bisphosphonates or ATV/statin group
- With aggressive periodontitis
- Who used tobacco in any form
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 | Open flap debridement group |
| OFD with PRFOral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect | Biological | PRF group |
| OFD with ALNOral prophylaxis followed by Open flap debridement (OFD) with 1% ALN gel placement into the bone defect | Drug | Alendronate group |
| OFD with ATVOral prophylaxis followed by Open flap debridement (OFD) with 1.2% ATV gel placement into the bone defect | Drug | Atorvastatin group |
Primary outcome
defect depth reduction (DDR)
Time frame: Change from baseline to 9 months
3 secondary outcomes
change in clinical attachment level (CAL)
Time frame: Change from baseline to 9 months
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 5 Aug 2015.
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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 2/3 study testing Open flap debridement (OFD), OFD with PRF and OFD with ALN in people with Chronic 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 Aug 2015. 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. 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). 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 Aug 2015.