Chronic PeriodontitisPhase 2/3NCT02600520
Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis
A Phase 2/3 study testing SRP with RSV gel LDD and SRP with ATV gel LDD 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 and radiographic efficacy of two local drug delivery systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- SRP with RSV gel LDD and SRP with ATV gel LDD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Nov 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy patients with PD ≥5mm or CA loss ≥4mm 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 statin group;
- on systemic statin therapy;
- with aggressive periodontitis;
- who used tobacco in any form;
- alcoholics;
- immunocompromised patients;
- pregnant or lactating females were excluded from the study
About this study
Official title: 1.2% Rosuvastatin Versus 1.2% Atorvastatin Local Drug Delivery in Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial
The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical and radiographic efficacy of two local drug delivery systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.
Read the detailed description
Background: Rosuvastatin (RSV) and Atorvastatin (ATV) 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 1.2% RSV and 1.2% ATV gel as local drug delivery systems in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis (CP).
Methods: A total of 90 intrabony defects were treated with either 1.2% RSV, 1.2% ATV or placebo gel LDD after SRP. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth and clinical attachment level) were recorded at baseline and 6 months. Radiographic intrabony defect depth change was calculated on standardized radiographs by using image analysis software at 6 months.
- Conditions
- Chronic Periodontitis
- Being tested
- SRP with RSV gel LDD, SRP with ATV gel LDD, SRP with placebo gel LDD
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRP with RSV gel LDDDrug
After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket
SRP with ATV gel LDDDrug
After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket
SRP with placebo gel LDDDrug
After SRP, placebo gel was delivered subgingivally into the pocket
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin Group | Active comparator | SRP followed by RSV gel LDD Receives: Drug: SRP with RSV gel LDD |
| Atorvastatin Group | Active comparator | SRP followed by ATV gel LDD Receives: Drug: SRP with ATV gel LDD |
| Placebo group | Placebo comparator | SRP followed by placebo gel LDD Receives: Drug: SRP with placebo gel LDD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intrabony defect depth from baseline to 6 months
Radiographic defect depth reduction (DDR) in the baseline to 6 months interval wiil be measured
Measured: Baseline to 6 months
Secondary outcomes (4)
Change in plaque index (PI) from baseline to 6 months
Reduction in plaque index (PI) from baseline to 6 months wiil be measured
Measured: Baseline to 6 months
Change in modified sulcus bleeding index (mSBI) from baseline to 6 months
Reduction in modified sulcus bleeding index (mSBI) from baseline to 6 months wiil be measured
Measured: Baseline to 6 months
Change in probing depth (PD) from baseline to 6 months
Reduction in probing depth (PD) from baseline to 6 months wiil be measured
Measured: Baseline to 6 months
Change in clinical attachment (CA) level from baseline to 6 months
Reduction in clinical attachment (CA) level from baseline to 6 months wiil be measured
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startNov 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
- 45 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
- NCT02600520
- Sponsor's protocol ID
- GDCRI/ACM/PG/PhD/2/2013-2014X
- Status last verified
- Nov 2015
- First submitted
- 6 Nov 2015
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1.2% Rosuvastatin Versus 1.2% Atorvastatin Local Drug Delivery in Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02600520
- Acronym / sponsor ID
- GDCRI/ACM/PG/PhD/2/2013-2014X
- Conditions
- Chronic Periodontitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 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.
The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical and radiographic efficacy of two local drug delivery systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.
Detailed description
Background: Rosuvastatin (RSV) and Atorvastatin (ATV) 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 1.2% RSV and 1.2% ATV gel as local drug delivery systems in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis (CP).
Methods: A total of 90 intrabony defects were treated with either 1.2% RSV, 1.2% ATV or placebo gel LDD after SRP. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth and clinical attachment level) were recorded at baseline and 6 months. Radiographic intrabony defect depth change was calculated on standardized radiographs by using image analysis software at 6 months.
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 |
|---|---|---|
| Rosuvastatin Group | Active comparator | Drug: SRP with RSV gel LDDSRP followed by RSV gel LDD |
| Atorvastatin Group | Active comparator | Drug: SRP with ATV gel LDDSRP followed by ATV gel LDD |
| Placebo group | Placebo comparator | Drug: SRP with placebo gel LDDSRP followed by placebo gel LDD |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systemically healthy patients with PD ≥5mm or CA loss ≥4mm 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 statin group;
- on systemic statin therapy;
- 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 |
|---|---|---|
| SRP with RSV gel LDDAfter SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket | Drug | Rosuvastatin Group |
| SRP with ATV gel LDDAfter SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket | Drug | Atorvastatin Group |
| SRP with placebo gel LDDAfter SRP, placebo gel was delivered subgingivally into the pocket | Drug | Placebo group |
Primary outcome
Change in intrabony defect depth from baseline to 6 months
Time frame: Baseline to 6 months
Radiographic defect depth reduction (DDR) in the baseline to 6 months interval wiil be measured
4 secondary outcomes
Change in plaque index (PI) from baseline to 6 months
Time frame: Baseline to 6 months
Change in modified sulcus bleeding index (mSBI) from baseline to 6 months
Time frame: Baseline to 6 months
Change in probing depth (PD) from baseline to 6 months
Time frame: Baseline to 6 months
Change in clinical attachment (CA) level from baseline to 6 months
Time frame: Baseline to 6 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 13 Nov 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 SRP with RSV gel LDD and SRP with ATV gel LDD 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 13 Nov 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. 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 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?
Change in intrabony defect depth from baseline to 6 months (time frame: Baseline to 6 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 13 Nov 2015.