Adult PeriodontitisPhase 4NCT03677297
"Efficacy Of 1.2% Rosuvastatin Gel In The Management Of Infrabony Defects"
A Phase 4 study testing Rosuvastatin in people with Adult Periodontitis, run by Dr. D. Y. Patil Dental College & Hospital at 1 site in India.
Trial summary
Study aims to evaluate clinical and radiographic effectiveness of 1.2% Rosuvastatin gel in the treatment of Infrabony defects in chronic periodontitis patients. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Periodontitis
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- 28 Jan 2016to 10 Nov 2017
- Phase
- Phase 4
- 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
- Age group between 30-50 years
- Probing pocket depth ≥ 5mm following initial therapy.
- Suitable interproximal angular infrabony defects of ≥3mm.
- Involved teeth should be vital and asymptomatic.
- Systemically healthy patients.
- Patients who demonstrate acceptable oral hygiene prior to access flap surgery.
- Patients agreed to sign informed consent and willing to return for the follow up visits.
Who cannot join
- Systemic statin therapy
- Known or suspected allergy to the statin group
- Allergy to sulfur containing drugs
- History of aggressive periodontitis.
- Presence of gingival recession at the surgical site.
- Mobility of study teeth ≥ grade I.
Show all 10Show fewer
- Use of tobacco in any form.
- Pregnant and lactating women.
- patients who have received any anti-inflammatory drugs and antibiotics in the previous six months.
- H/O osteoporosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Treatment Of Infrabony Defects With and Without 1.2% Rosuvastatin Gel: In-Vivo Study
Study aims to evaluate clinical and radiographic effectiveness of 1.2% Rosuvastatin gel in the treatment of Infrabony defects in chronic periodontitis patients.
Read the detailed description
Source from where the patients will be selected:
10 patients with chronic periodontitis having two or more infrabony defects will be selected from the Outpatient section of Dept. of Periodontology, Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune - 18.
A detailed clinical examination, case history and written consent will be obtained from all the participants.
Before surgery, each patient will be given careful instructions regarding proper oral hygiene measures. A full-mouth phase I therapy will be performed. A periodontal re-evaluation will be performed after 4 to 6 weeks of phase 1 therapy to confirm the desired sites for the study. The selected sites will be divided randomly by using a Sequentially numbered, opaque, sealed envelopes (SNOSE) randomization into control and test sites. The control site will be treated with Access Flap Surgery (AFS), whereas test sites will be treated with AFS and 1.2% Rosuvastatin gel. Suitable antibiotics and analgesics will be prescribed along with Chlorhexidine digluconate rinses (0.2%) twice daily for 14 days. Patients will be examined at 4 weeks, 3 and 6 month after surgery.
- Conditions
- Adult Periodontitis
- Being tested
- Rosuvastatin
- Keywords
- Intervention Study, Rosuvastatin, Periodontitis
- Medical subject headings
- Chronic Periodontitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called No intervention used on Control site
Test sites were treated with access flap surgery and 1.2% Rosuvastatin gel
| Study group | Role | What they receive |
|---|---|---|
| ROSUVASTATIN | Experimental | 1.2% Rosuvastatin Gel. Insertion in infrabony defects once Receives: Drug: Rosuvastatin |
| placebo | Placebo comparator | No intervention used on control site Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone fill
Radiographic parameter measuring distance from cemento-enamel junction to the base of the defect.
Difference in the measurement at the end of 6 months shows the amount of bone fill
Measured: 6 months
Secondary outcomes (4)
Probing depth
Clinical parameters- Reduction in this parameter is desired at the end of 6 months
Measured: 6 months
relative attachment level
Clinical parameters- Reduction in this parameter at the end of 6 months shows gain in attachment
Measured: 6 months
plaque index
Clinical parameters- Reduction in plaque index at the end of 6 months shows improvement in gingival health
Measured: 6 months
bleeding index
Clinical parameters- Reduction in bleeding index at the end of 6 months shows improvement in gingival health
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start28 Jan 2016
- Primary completion1 Aug 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. D. Y. Patil Dental College & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR. SUKHADA DEO, Dr. D. Y. Patil Dental College & Hospital
- Investigators
- Sukhada D Deo, BDS, Principal investigator, Dr. D. Y. Patil Dental College & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677297
- Sponsor's protocol ID
- DPU/R & R (D)/ 98(10)/ 16
- Status last verified
- Sep 2018
- First submitted
- 17 Aug 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Treatment Of Infrabony Defects With and Without 1.2% Rosuvastatin Gel: In-Vivo Study
- ClinicalTrials.gov ID
- NCT03677297
- Acronym / sponsor ID
- DPU/R & R (D)/ 98(10)/ 16
- Conditions
- Adult Periodontitis
- Keywords
- Intervention Study, Rosuvastatin, Periodontitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dr. D. Y. Patil Dental College & HospitalUniversity, hospital or other
- Study start
- 28 Jan 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 19 Sep 2018 (actual)
- 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.
Study aims to evaluate clinical and radiographic effectiveness of 1.2% Rosuvastatin gel in the treatment of Infrabony defects in chronic periodontitis patients.
Detailed description
Source from where the patients will be selected:
10 patients with chronic periodontitis having two or more infrabony defects will be selected from the Outpatient section of Dept. of Periodontology, Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune - 18.
A detailed clinical examination, case history and written consent will be obtained from all the participants.
Before surgery, each patient will be given careful instructions regarding proper oral hygiene measures. A full-mouth phase I therapy will be performed. A periodontal re-evaluation will be performed after 4 to 6 weeks of phase 1 therapy to confirm the desired sites for the study. The selected sites will be divided randomly by using a Sequentially numbered, opaque, sealed envelopes (SNOSE) randomization into control and test sites. The control site will be treated with Access Flap Surgery (AFS), whereas test sites will be treated with AFS and 1.2% Rosuvastatin gel. Suitable antibiotics and analgesics will be prescribed along with Chlorhexidine digluconate rinses (0.2%) twice daily for 14 days. Patients will be examined at 4 weeks, 3 and 6 month after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROSUVASTATIN | Experimental | Drug: Rosuvastatin1.2% Rosuvastatin Gel. Insertion in infrabony defects once |
| placebo | Placebo comparator | Drug: RosuvastatinNo intervention used on control site |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age group between 30-50 years
- Probing pocket depth ≥ 5mm following initial therapy.
- Suitable interproximal angular infrabony defects of ≥3mm.
- Involved teeth should be vital and asymptomatic.
- Systemically healthy patients.
Key exclusion criteria (10 listed)
- Systemic statin therapy
- Known or suspected allergy to the statin group
- Allergy to sulfur containing drugs
- History of aggressive periodontitis.
- Presence of gingival recession at the surgical site.
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: No intervention used on Control siteTest sites were treated with access flap surgery and 1.2% Rosuvastatin gel | Drug | ROSUVASTATIN, placebo |
Primary outcome
Bone fill
Time frame: 6 months
Radiographic parameter measuring distance from cemento-enamel junction to the base of the defect. Difference in the measurement at the end of 6 months shows the amount of bone fill
4 secondary outcomes
Probing depth
Time frame: 6 months
relative attachment level
Time frame: 6 months
plaque index
Time frame: 6 months
bleeding index
Time frame: 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 19 Sep 2018.
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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.
Sukhada D Deo, BDS principal investigator
Dr. D. Y. Patil Dental College & Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin in people with Adult Periodontitis, run by Dr. D. Y. Patil Dental College & Hospital at 1 site in India.
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 7 inclusion and 10 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 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Bone fill (time frame: 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 19 Sep 2018.