Chronic PeriodontitisPhase 2/3NCT02386033
Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects
A Phase 2/3 study testing Atorvastatin (ATV) in people with Chronic Periodontitis, run by Government Dental College and Research Institute, Bangalore.
Trial summary
ABSTARCT Background: Atorvastatin is an inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. Lately, it has shown to have anti-inflammatory and bone stimulatory effects. Read more about this study
- Who is it for?
- Ages 30 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Atorvastatin (ATV)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jul 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- lower first molars demonstrating a probing pocket depth of 5 mm and horizontal probing depth of 3 mm following phase 1 therapy, with furcation defects (degree II) present bucally in asymptomatic, vital lower first molars, with a furcation radiolucency on a periapical radiograph of the molars.
Who cannot join
- patients with systemic diseases like cardiovascular disease
- diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
- pregnant/lactating females
- tobacco users
- alcoholics
- patients with unsatisfactory oral hygiene (plaque index greater than 1.5)
- teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility
- Furthermore, patients allergic to ATV or other statins or those taking ATV/other statins systemically were excluded.
About this study
Official title: Clinical Efficacy of Subgingivally Delivered Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial .
ABSTARCT Background: Atorvastatin is an inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. Lately, it has shown to have anti-inflammatory and bone stimulatory effects. The aim of the current study is to explore the effectiveness of 1.2% atorvastatin (ATV) as an adjunct to scaling and root planning (SRP) in the treatment of mandibular degree II furcation defects.
Method: A total of sixty subjects were randomly assigned to two treatment groups. 1. SRP plus placebo gel 2. SRP plus 1.2% ATV gel. Clinical parameters like probing depth (PD), relative vertical clinical attachment level (RVCAL) , relative horizontal clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index were recorded at baseline and then at 3, 6 and 9 months. The radiological assessment of bone defect fill was done at 6 and 9 months, using a computer-aided software.
Read the detailed description
Two groups were made. One was delivered with ATV after SRP, the other was delivered with placebo gel after SRP.
- Conditions
- Chronic Periodontitis
- Being tested
- Atorvastatin (ATV), Placebo Gel
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin (ATV)Drug
Also called ATV gel
After SRP, ATV gel was delivered subgingivally into the pocket
Placebo GelDrug
After SRP, placebo gel was delivered subgingivally into the pocket
| Study group | Role | What they receive |
|---|---|---|
| SRP plus placebo | Placebo comparator | SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket Receives: Drug: Placebo Gel |
| SRP plus Atorvastatin | Active comparator | SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally Receives: Drug: Atorvastatin (ATV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of bone fill
Measured: baseline to 9 months
Secondary outcomes (5)
change in Relative vertical clinical attachment level
Measured: baseline to 9 months
change in RHCAL (relative horizontal clinical attachment level)
Measured: baseline to 9 months
change in probing depth
Measured: baseline to 9 months
change in site specific plaque index
Measured: baseline to 9 months
change in modified sulcus bleeding index
Measured: 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 posted11 Mar 2015 (estimated)
- Study startNov 2013
- Primary completionJul 2014
- Study completionJul 2014
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, Investigator
- Enrolment
- 60 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
- NCT02386033
- Sponsor's protocol ID
- GDCRI/ACM/PG/PhD/2/2013-2014AB
- Status last verified
- Nov 2014
- First submitted
- 30 Nov 2014
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Subgingivally Delivered Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial .
- ClinicalTrials.gov ID
- NCT02386033
- Acronym / sponsor ID
- GDCRI/ACM/PG/PhD/2/2013-2014AB
- Conditions
- Chronic Periodontitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Mar 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.
ABSTARCT Background: Atorvastatin is an inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. Lately, it has shown to have anti-inflammatory and bone stimulatory effects. The aim of the current study is to explore the effectiveness of 1.2% atorvastatin (ATV) as an adjunct to scaling and root planning (SRP) in the treatment of mandibular degree II furcation defects.
Method: A total of sixty subjects were randomly assigned to two treatment groups. 1. SRP plus placebo gel 2. SRP plus 1.2% ATV gel. Clinical parameters like probing depth (PD), relative vertical clinical attachment level (RVCAL) , relative horizontal clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index were recorded at baseline and then at 3, 6 and 9 months. The radiological assessment of bone defect fill was done at 6 and 9 months, using a computer-aided software.
Detailed description
Two groups were made. One was delivered with ATV after SRP, the other was delivered with placebo gel after SRP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRP plus placebo | Placebo comparator | Drug: Placebo GelSRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket |
| SRP plus Atorvastatin | Active comparator | Drug: Atorvastatin (ATV)SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- lower first molars demonstrating a probing pocket depth of 5 mm and horizontal probing depth of 3 mm following phase 1 therapy, with furcation defects (degree II) present bucally in asymptomatic, vital lower first molars, with a furcation radiolucency on a periapical radiograph of the molars.
Key exclusion criteria (8 listed)
- patients with systemic diseases like cardiovascular disease
- diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
- pregnant/lactating females
- tobacco users
- alcoholics
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 |
|---|---|---|
| Atorvastatin (ATV)Also: ATV gelAfter SRP, ATV gel was delivered subgingivally into the pocket | Drug | SRP plus Atorvastatin |
| Placebo GelAfter SRP, placebo gel was delivered subgingivally into the pocket | Drug | SRP plus placebo |
Primary outcome
amount of bone fill
Time frame: baseline to 9 months
5 secondary outcomes
change in Relative vertical clinical attachment level
Time frame: baseline to 9 months
change in RHCAL (relative horizontal clinical attachment level)
Time frame: baseline to 9 months
change in probing depth
Time frame: baseline to 9 months
change in site specific plaque index
Time frame: baseline to 9 months
change in modified sulcus bleeding index
Time frame: 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 11 Mar 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 Atorvastatin (ATV) 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 11 Mar 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?
amount of bone fill (time frame: 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 11 Mar 2015.