Chronic PeriodontitisPhase 2/3NCT02283515
Efficacy of Locally Delivred 1.2% Rosuvastatin Gel in Chronic Periodontitis
A Phase 2/3 study testing Rosuvastatin in people with Chronic Periodontitis, run by Government Dental College and Research Institute, Bangalore.
Trial summary
BACKGROUND: Chronic periodontitis (CP) is an inflammatory condition affecting tooth supporting tissues and alveolar bone that surround the tooth leading to formation of deepend gingival sulcus that is highly prone to pathologic changes, ultimately bone resorption and tooth loss. Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 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 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically sound with moderate probing depth (PD) of 5- 6 mm or clinical attachment loss (CAL) of 4 - 6 mm) or deep pockets (PD ≥ 7 mm or CAL of 6 - 9 mm) and vertical bone loss ≥ 3 mm on intraoral periapical radiographs.
- Subjects with ≥ 20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy were included in the study.
Who cannot join
- Patients on systemic statin therapy with known or suspected allergy to the RSV group, patients with any other forms of periodontitis, use of tobacoo in any form, smokers, alcoholics, immune-compromised and systemically unhealthy patients, and pregnant or lactating females were excluded.
About this study
Official title: Efficacy of Locally Delivered 1.2% Rosuvastatin Gel in Non Surgical Treatment of Chronic Periodontitis Patients: A Randomised Clinical Control Trial.
BACKGROUND: Chronic periodontitis (CP) is an inflammatory condition affecting tooth supporting tissues and alveolar bone that surround the tooth leading to formation of deepend gingival sulcus that is highly prone to pathologic changes, ultimately bone resorption and tooth loss. In the literature, several pharmacologic agents have been administration via local delivery route, directly into diseased sites affirming greater improvement in periodontal status. Therefore, present study was conducted to determine the clinical effectiveness of subgingivally delivered 1.2% Rosuvastatin gel incorporated into an methylcellulose vehicle for its controlled release into intrabony defect sites in adjunct to scaling and root planing for treatment of chronic periodontitis patients.
MATERIAL AND METHODS: Sixty five patients were categorized into two treatment groups: group I -SRP plus RSV, 1.2 mg and group II -SRP plus placebo. Clinical parameters included modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL), were recorded at baseline before SRP and at 1, 3, 4, and 6 months. Radiologic assessment of intrabony defect (IBD) fill was analysed at baseline and after 6months using computer-aided software.
Read the detailed description
Rosuvastatin (RSV) is one of new synthetic, second-generation, sulfur-containing, hydrophilic statin, a highly efficient competitive inhibitors of HMG CoA Reductase having important role in reducing serum cholesterol concentrations and lowers the risk of cardiovascular disease. It has potent anti-inflammatory effects, mediated via vascular endothelium derived nitric oxide (eNO) that inhibits P selectin synthesis by endothelial cells. This protective action is evidenced by reduced levels of high-sensitivity C-Reactive Protein (hs-CRP) , a clinical marker of inflammation produced in response to proinflammatory cytokines such as interleukin-6 (IL-6), therefore it contributes to the prevention and remission of inflammatory diseases. Recently, an in-vivo study demonstrated that RSV promotes osteoblast differentiation, by regulating the expression of solute carrier (Slco1a1), which may constitute the transport system for RSV across the cell membrane in mature osteoblasts.
SRP plus RSV(1.2 mg/0.1 ml) in situ gel (group I) or SRP plus placebo gel (group II) local drug delivery
- Conditions
- Chronic Periodontitis
- Being tested
- Rosuvastatin
- Keywords
- chronic periodontitis, local drug delivery, rosuvastatin, osseo-differentiation
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Hydrophilic statin
Rosuvastatin (RSV) is one of new synthetic, second-generation, sulfur-containing, hydrophilic statin, a highly efficient competitive inhibitors of HMG CoA Reductase having important role in reducing serum cholesterol concentrations and lowers the risk of cardiovascular disease.
| Study group | Role | What they receive |
|---|---|---|
| group I - Rosuvastatin, 1.2 mg | Active comparator | Rosuvastatin- locally placed in intrabony defect sites. Receives: Drug: Rosuvastatin |
| group II - placebo | Placebo comparator | placebo-placed locally in intrabony defects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study was complete bone defect fill.
Using radiographic analyser bone defect fill was analysed
Measured: 24 weeks complete bone defect fill.
Secondary outcomes (3)
Probing Depth.
Using UNC-15 probe
Measured: an average of 24 weeks Probing depth
Clinical Attachment Level
Using UNC-15 probe and acrylic stents CAL was analysed
Measured: 24 weeks
modified Sulcus BIeeding Index
Using a WALKING METHOD OF PROBING
Measured: 12 and 24 weeks
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 startJan 2014
- Primary completionJun 2014
- Study completionJun 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 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
- NCT02283515
- Sponsor's protocol ID
- GDCRI/ACM/PG/PhD/10/2013-14A
- Status last verified
- Nov 2014
- First submitted
- 27 Sep 2014
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
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
- Efficacy of Locally Delivered 1.2% Rosuvastatin Gel in Non Surgical Treatment of Chronic Periodontitis Patients: A Randomised Clinical Control Trial.
- ClinicalTrials.gov ID
- NCT02283515
- Acronym / sponsor ID
- GDCRI/ACM/PG/PhD/10/2013-14A
- Conditions
- Chronic Periodontitis
- Keywords
- chronic periodontitis, local drug delivery, rosuvastatin, osseo-differentiation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 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.
BACKGROUND: Chronic periodontitis (CP) is an inflammatory condition affecting tooth supporting tissues and alveolar bone that surround the tooth leading to formation of deepend gingival sulcus that is highly prone to pathologic changes, ultimately bone resorption and tooth loss. In the literature, several pharmacologic agents have been administration via local delivery route, directly into diseased sites affirming greater improvement in periodontal status. Therefore, present study was conducted to determine the clinical effectiveness of subgingivally delivered 1.2% Rosuvastatin gel incorporated into an methylcellulose vehicle for its controlled release into intrabony defect sites in adjunct to scaling and root planing for treatment of chronic periodontitis patients.
MATERIAL AND METHODS: Sixty five patients were categorized into two treatment groups: group I -SRP plus RSV, 1.2 mg and group II -SRP plus placebo. Clinical parameters included modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL), were recorded at baseline before SRP and at 1, 3, 4, and 6 months. Radiologic assessment of intrabony defect (IBD) fill was analysed at baseline and after 6months using computer-aided software.
Detailed description
Rosuvastatin (RSV) is one of new synthetic, second-generation, sulfur-containing, hydrophilic statin, a highly efficient competitive inhibitors of HMG CoA Reductase having important role in reducing serum cholesterol concentrations and lowers the risk of cardiovascular disease. It has potent anti-inflammatory effects, mediated via vascular endothelium derived nitric oxide (eNO) that inhibits P selectin synthesis by endothelial cells. This protective action is evidenced by reduced levels of high-sensitivity C-Reactive Protein (hs-CRP) , a clinical marker of inflammation produced in response to proinflammatory cytokines such as interleukin-6 (IL-6), therefore it contributes to the prevention and remission of inflammatory diseases. Recently, an in-vivo study demonstrated that RSV promotes osteoblast differentiation, by regulating the expression of solute carrier (Slco1a1), which may constitute the transport system for RSV across the cell membrane in mature osteoblasts.
SRP plus RSV(1.2 mg/0.1 ml) in situ gel (group I) or SRP plus placebo gel (group II) local drug delivery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I - Rosuvastatin, 1.2 mg | Active comparator | Drug: RosuvastatinRosuvastatin- locally placed in intrabony defect sites. |
| group II - placebo | Placebo comparator | –placebo-placed locally in intrabony defects. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Systemically sound with moderate probing depth (PD) of 5- 6 mm or clinical attachment loss (CAL) of 4 - 6 mm) or deep pockets (PD ≥ 7 mm or CAL of 6 - 9 mm) and vertical bone loss ≥ 3 mm on intraoral periapical radiographs.
- Subjects with ≥ 20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy were included in the study.
Key exclusion criteria (1 listed)
- Patients on systemic statin therapy with known or suspected allergy to the RSV group, patients with any other forms of periodontitis, use of tobacoo in any form, smokers, alcoholics, immune-compromised and systemically unhealthy patients, and pregnant or lactating females were excluded.
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 |
|---|---|---|
| RosuvastatinAlso: Hydrophilic statinRosuvastatin (RSV) is one of new synthetic, second-generation, sulfur-containing, hydrophilic statin, a highly efficient competitive inhibitors of HMG CoA Reductase having important role in reducing serum cholesterol concentrations and lowers the risk of cardiovascular disease. | Drug | group I - Rosuvastatin, 1.2 mg |
Primary outcome
The primary outcome of the study was complete bone defect fill.
Time frame: 24 weeks complete bone defect fill.
Using radiographic analyser bone defect fill was analysed
3 secondary outcomes
Probing Depth.
Time frame: an average of 24 weeks Probing depth
Clinical Attachment Level
Time frame: 24 weeks
modified Sulcus BIeeding Index
Time frame: 12 and 24 weeks
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 2/3 study testing Rosuvastatin 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 2 inclusion and 1 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 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?
The primary outcome of the study was complete bone defect fill. (time frame: 24 weeks complete bone defect fill.). 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.