Chronic PeriaortitisPhase 4NCT03009097
Atorvastatin as an Adjunct to DFDBA in Intrabony Defects
A Phase 4 study testing DFDBA and DFDBA with atorvastatin in people with Chronic Periaortitis and Intrabony Periodontal Defect, run by Kamineni Institute of Dental Sciences.
Trial summary
Periodontitis is a major oral health problem which leads to the progressive destruction of periodontal ligament and alveolar bone with pocket formation, recession or both. The ultimate goal of periodontal therapy is to regenerate the lost periodontal tissue. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Periaortitis, Intrabony Periodontal Defect
- What is being tested?
- DFDBA and DFDBA with atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Aug 2014
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systemically healthy individual based on personal and medical history.
- Presentation of untreated Chronic Periodontitis with intrabony defect having probing pocket depth (PPD) ≥5mm or clinical attachment loss of ≥ 3mm and radiographic signs of angular bone loss.
Who cannot join
- Patients diagnosed and treated for systemic disease
- Pregnant and Lactating women
- Smokers
- History of allergy to statin group or patients on systemic statin therapy.
- History of antibiotic or periodontal therapy for the past 6 months.
About this study
Official title: "Comparative Evaluation Of The Efficacy Of Atorvastatin Gel As An Adjunct To Allografts In The Treatment Of Intrabony Defects" - A Clinico Radiological Study
Periodontitis is a major oral health problem which leads to the progressive destruction of periodontal ligament and alveolar bone with pocket formation, recession or both. The ultimate goal of periodontal therapy is to regenerate the lost periodontal tissue. The most common form of regenerative periodontal therapy is the use of bone grafts which stimulate bone formation by the processes of osteoinduction and osteoconduction.
Statins are a group of lipid lowering drugs which inhibit bone resorption by inhibition of the enzyme HMG-CoA reductase. They also stimulate new bone formation by local stimulation of BMP-2, a major bone growth regulatory factor. They also have anti-inflammatory and anti oxidant properties.
Read more
Very few studies exist evaluating the beneficiary effects of grafts if combined with the statins which might enhance the regeneration by bone grafts.
Hence, the present study was carried out in an attempt to comparatively evaluate clinically and radiologically, the efficacy of atorvastatin gel as an adjunct to allograft in the treatment of intrabony defects.
Read the detailed description
A total of 26 intrabony defects in patients with chronic periodontitis as diagnosed by radiographs, were selected for the study after taking an informed consent. The selected sites were randomized in 2 treatment groups.
Group I - sites were treated with allograft (DFDBA) Group II - sites were treated with allograft (DFDBA) in combination with Atorvastatin gel.
Clinical parameters like probing depth and clinical attachment level and radiological assessment of intrabony defect fill were done at baseline and 3 and 6 months postoperatively.
- Conditions
- Chronic Periaortitis, Intrabony Periodontal Defect
- Being tested
- DFDBA, DFDBA with atorvastatin
- Keywords
- Chronic periodontitis, atorvastatin, intrabony defect
- Medical subject headings
- Retroperitoneal Fibrosis, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFDBABiological
Also called Allograft
13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA)
DFDBA with atorvastatinDrug
Also called atorvastatin gel
13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA) in combination with atorvastatin gel
| Study group | Role | What they receive |
|---|---|---|
| DFDBA | Active comparator | 13 intrabony defects in chronic periodontitis patients were treated with DFDBA Receives: Biological: DFDBA |
| DFDBA with Atorvastatin | Active comparator | 13 intrabony defects in chronic periodontitis patients were treated with DFDBA in combination with Atorvastatin gel. Receives: Drug: DFDBA with atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone fill in mm was measured by taking radiographs
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 posted4 Jan 2017 (estimated)
- Study startApr 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriaortitisStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kamineni Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ETIKA RATHI, Kamineni Institute of Dental Sciences
- Investigators
- Etika Rathi, MDS, Principal investigator, Kamineni Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009097
- Sponsor's protocol ID
- kamineni perio
- Status last verified
- Dec 2016
- First submitted
- 28 Dec 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
Publications
Pradeep AR, Kumari M, Rao NS, Martande SS, Naik SB. Clinical efficacy of subgingivally delivered 1.2% atorvastatin in chronic periodontitis: a randomized controlled clinical trial. J Periodontol. 2013 Jul;84(7):871-9. doi: 10.1902/jop.2012.120393. Epub 2012 Oct 2.
PubMed 23030241
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparative Evaluation Of The Efficacy Of Atorvastatin Gel As An Adjunct To Allografts In The Treatment Of Intrabony Defects" - A Clinico Radiological Study
- ClinicalTrials.gov ID
- NCT03009097
- Acronym / sponsor ID
- kamineni perio
- Conditions
- Chronic Periaortitis, Intrabony Periodontal Defect
- Keywords
- Chronic periodontitis, atorvastatin, intrabony defect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kamineni Institute of Dental SciencesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Jan 2017 (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.
Periodontitis is a major oral health problem which leads to the progressive destruction of periodontal ligament and alveolar bone with pocket formation, recession or both. The ultimate goal of periodontal therapy is to regenerate the lost periodontal tissue. The most common form of regenerative periodontal therapy is the use of bone grafts which stimulate bone formation by the processes of osteoinduction and osteoconduction.
Statins are a group of lipid lowering drugs which inhibit bone resorption by inhibition of the enzyme HMG-CoA reductase. They also stimulate new bone formation by local stimulation of BMP-2, a major bone growth regulatory factor. They also have anti-inflammatory and anti oxidant properties.
Very few studies exist evaluating the beneficiary effects of grafts if combined with the statins which might enhance the regeneration by bone grafts.
Hence, the present study was carried out in an attempt to comparatively evaluate clinically and radiologically, the efficacy of atorvastatin gel as an adjunct to allograft in the treatment of intrabony defects.
Detailed description
A total of 26 intrabony defects in patients with chronic periodontitis as diagnosed by radiographs, were selected for the study after taking an informed consent. The selected sites were randomized in 2 treatment groups.
Group I - sites were treated with allograft (DFDBA) Group II - sites were treated with allograft (DFDBA) in combination with Atorvastatin gel.
Clinical parameters like probing depth and clinical attachment level and radiological assessment of intrabony defect fill were done at baseline and 3 and 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DFDBA | Active comparator | Biological: DFDBA13 intrabony defects in chronic periodontitis patients were treated with DFDBA |
| DFDBA with Atorvastatin | Active comparator | Drug: DFDBA with atorvastatin13 intrabony defects in chronic periodontitis patients were treated with DFDBA in combination with Atorvastatin gel. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Systemically healthy individual based on personal and medical history.
- Presentation of untreated Chronic Periodontitis with intrabony defect having probing pocket depth (PPD) ≥5mm or clinical attachment loss of ≥ 3mm and radiographic signs of angular bone loss.
Key exclusion criteria (5 listed)
- Patients diagnosed and treated for systemic disease
- Pregnant and Lactating women
- Smokers
- History of allergy to statin group or patients on systemic statin therapy.
- History of antibiotic or periodontal therapy for the past 6 months.
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 |
|---|---|---|
| DFDBAAlso: Allograft13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA) | Biological | DFDBA |
| DFDBA with atorvastatinAlso: atorvastatin gel13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA) in combination with atorvastatin gel | Drug | DFDBA with Atorvastatin |
Primary outcome
bone fill in mm was measured by taking radiographs
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 4 Jan 2017.
- Background: PubMed 23030241Pradeep AR, Kumari M, Rao NS, Martande SS, Naik SB. Clinical efficacy of subgingivally delivered 1.2% atorvastatin in chronic periodontitis: a randomized controlled clinical trial. J Periodontol. 2013 Jul;84(7):871-9. doi: 10.1902/jop.2012.120393. Epub 2012 Oct 2.
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.
Etika Rathi, MDS principal investigator
Kamineni Institute of Dental Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DFDBA and DFDBA with atorvastatin in people with Chronic Periaortitis and Intrabony Periodontal Defect, run by Kamineni Institute of Dental Sciences.
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 5 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 4 Jan 2017. 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. 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 in mm was measured by taking radiographs (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03009097, which also lists 1 linked publication.
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 4 Jan 2017.