Chronic PeriodontitisPhase 2/3NCT02455869
Comparison of Alendronate With Atorvastatin in Chronic Periodontitis
A Phase 2/3 study testing SRP and Atorvastatin and SRP and Alendronate 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 two local drug delivery systems containing 1% ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP. 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 and Atorvastatin and SRP and Alendronate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Jul 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 30 to 50 years
- All sexes
- 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/bisphosphonate group and ATV/statin group;
- on systemic ALN/bisphosphonate and therapy 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 Subgingivally Delivered 1% Alendronate Versus 1.2% Atorvastatin Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial
The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of two local drug delivery systems containing 1% ALN 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: 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 1% ALN and 1.2% ATV gel as a local drug delivery system in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.
Methods: A total of 90 intrabony defects were treated with either1%ALN, 1.2% ATV or placebo gel. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth [PD], and clinical attachment level [CAL]) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months.
- Conditions
- Chronic Periodontitis
- Being tested
- SRP and Placebo gel, SRP and Atorvastatin, SRP and Alendronate
- 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 and Placebo gelDrug
After SRP, placebo gel was delivered subgingivally into the pocket
SRP and AtorvastatinDrug
After SRP, Atorvastatin gel was delivered subgingivally into the pocket
SRP and AlendronateDrug
After SRP, Alendronate gel was delivered subgingivally into the pocket
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket Receives: Drug: SRP and Placebo gel |
| Atorvastatin group | Active comparator | SRP plus Atorvastatin SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally Receives: Drug: SRP and Atorvastatin |
| Alendronate Group | Active comparator | Alendronate SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally Receives: Drug: SRP and Alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in defect depth reduction from baseline to 6 months and from baseline to 9 months
Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval
Measured: Baseline to 6 months and Baseline to 9 months
Secondary outcomes (4)
Plaque index
Plaque index will be measured at 3, 6 and 9 months
Measured: 3,6 and 9 months
Modified sulcus bleeding index
Modified sulcus bleeding index will be measured at 3, 6 and 9 months
Measured: 3,6 and 9 months]
Probing pocket depth
Probing pocket depth will be measured at 3, 6 and 9 months
Measured: 3,6 and 9 months]
Clinical attachment level
Clinical attachment level will be measured at 3, 6 and 9 months
Measured: 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 posted28 May 2015 (estimated)
- Study startJul 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 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 104 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
- NCT02455869
- Sponsor's protocol ID
- GDCRI/ACM/PG/PhD/2/2013-2014J
- Status last verified
- May 2015
- First submitted
- 19 May 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Subgingivally Delivered 1% Alendronate Versus 1.2% Atorvastatin Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02455869
- Acronym / sponsor ID
- GDCRI/ACM/PG/PhD/2/2013-2014J
- Conditions
- Chronic Periodontitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 May 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 two local drug delivery systems containing 1% ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.
Detailed description
Background: 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 1% ALN and 1.2% ATV gel as a local drug delivery system in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.
Methods: A total of 90 intrabony defects were treated with either1%ALN, 1.2% ATV or placebo gel. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth [PD], and clinical attachment level [CAL]) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: SRP and Placebo gelSRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket |
| Atorvastatin group | Active comparator | Drug: SRP and AtorvastatinSRP plus Atorvastatin SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally |
| Alendronate Group | Active comparator | Drug: SRP and AlendronateAlendronate SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally |
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 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/bisphosphonate group and ATV/statin group;
- on systemic ALN/bisphosphonate and therapy 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 |
|---|---|---|
| SRP and Placebo gelAfter SRP, placebo gel was delivered subgingivally into the pocket | Drug | Placebo group |
| SRP and AtorvastatinAfter SRP, Atorvastatin gel was delivered subgingivally into the pocket | Drug | Atorvastatin group |
| SRP and AlendronateAfter SRP, Alendronate gel was delivered subgingivally into the pocket | Drug | Alendronate Group |
Primary outcome
Change in defect depth reduction from baseline to 6 months and from baseline to 9 months
Time frame: Baseline to 6 months and Baseline to 9 months
Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval
4 secondary outcomes
Plaque index
Time frame: 3,6 and 9 months
Modified sulcus bleeding index
Time frame: 3,6 and 9 months]
Probing pocket depth
Time frame: 3,6 and 9 months]
Clinical attachment level
Time frame: 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 28 May 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 and Atorvastatin and SRP and Alendronate 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 28 May 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 defect depth reduction from baseline to 6 months and from baseline to 9 months (time frame: Baseline to 6 months and 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 28 May 2015.