Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, RegenerationPhase 2/3NCT03178526
The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis
A Phase 2/3 study testing Lovastatin gel in people with Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, Regeneration, run by Islamic Azad University, Sanandaj.
Trial summary
Aim: dis double-blind split-mouth clinical trial study was performed to evaluate teh clinical and radiographic effect of local delivery of lovastatin gel as an adjunct to scaling and root planning (SRP) in teh treatment of chronic periodontitis. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, Regeneration
- What is being tested?
- Lovastatin gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 24 Dec 2015to 13 Feb 2016
- 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 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 24 patients wif periodontitis chronic and TEMPhas a 2 molar symmetrically in the lower jaw pockets of periodontal depth of at least 4 mm and CAL greater than 3 mm in at least one of the surfaces of the teeth, the X-ray bars from both sides of the molar regions jaw bottom, from CEJ and alveolar crest was more than 3 mm, were selected
Who cannot join
- systemic disease
- pregnancy or breastfeeding
- allergy drug used
- smoking
- medication 6. not willing to consent to participate in the study
- 7-Trismus 8-The type of disease periodontal (Aggressive) 9. History of periodontal treatment in the previous 6 months 10-orthodontic treatment
About this study
Official title: The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis Randomized Controlled Trial Split-mouth
Aim: dis double-blind split-mouth clinical trial study was performed to evaluate teh clinical and radiographic effect of local delivery of lovastatin gel as an adjunct to scaling and root planning (SRP) in teh treatment of chronic periodontitis.
Method and Materials: 15 patients with two mandibular molar teeth with probing depth (PD)≥3 mm, clinical attachment level (CAL)≥3 mm and bone loss more than 3 mm according to parallel periapical x-ray and distance from CEJ to alveolar crest, were selected.Totally 24 mandibular molars were selected for teh study.
Clinical periodontal parameters included PD, CAL, bleeding index(BI), plaque index(PI) were recorded for teh selected teeth at baseline and at 1,3 and 6 months. Radiographic assessments were performed at baseline and after 6 months. At one side teh pockets around randomly selected molar were injected with a blunt syringe filled with lovastatin gel 1.2%( case group=B), and on teh other side, teh pockets were filled with a placebo gel by a blunt syringe ( control group=A).Two-way repeated measure ANOVA test and T-test were used for statistic analysis Spss 23.( P<0.05) was considered significant.
Read the detailed description
Statins are an important group of hypolipidemic drugs dat are able to modulate inflammation and alveolar bone loss. Rosuvastatin (RSV) and atorvastatin (ATV) are non to inhibit osteoclastic bone resorption and has been proposed to has osteostimulative properties.
- Being tested
- Lovastatin gel, Placebo
- Medical subject headings
- Alveolar Bone Loss, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lovastatin gelDrug
Also called Group A
Lovastatin gel1.2% topical gel was put into teh periodontal pocket using an insulin syringe
PlaceboDrug
placebo gel
| Study group | Role | What they receive |
|---|---|---|
| levostatin gel | Active comparator | levostatin gel 1.2% topical gel was put into teh periodontal pocket using an insulin syringe Receives: Drug: Lovastatin gel |
| placebo gel | Placebo comparator | placebo gel 1.2% topical gel was put into the periodontal pocket using an insulin syringe Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone defect fill
radiographic analysis for bone defect
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start24 Dec 2015
- Primary completion13 Jan 2016
- Study completion13 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, RegenerationStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University, Sanandaj
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amirhossein Farahmand, Islamic Azad University, Sanandaj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178526
- Sponsor's protocol ID
- 25187
- Status last verified
- Jul 2019
- First submitted
- 5 Jun 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis Randomized Controlled Trial Split-mouth
- ClinicalTrials.gov ID
- NCT03178526
- Acronym / sponsor ID
- 25187
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Islamic Azad University, SanandajUniversity, hospital or other
- Study start
- 24 Dec 2015 (actual)
- Primary completion
- 13 Jan 2016 (actual)
- Study completion
- 13 Feb 2016 (actual)
- First posted
- 7 Jun 2017 (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.
Aim: dis double-blind split-mouth clinical trial study was performed to evaluate teh clinical and radiographic effect of local delivery of lovastatin gel as an adjunct to scaling and root planning (SRP) in teh treatment of chronic periodontitis.
Method and Materials: 15 patients with two mandibular molar teeth with probing depth (PD)≥3 mm, clinical attachment level (CAL)≥3 mm and bone loss more than 3 mm according to parallel periapical x-ray and distance from CEJ to alveolar crest, were selected.Totally 24 mandibular molars were selected for teh study.
Clinical periodontal parameters included PD, CAL, bleeding index(BI), plaque index(PI) were recorded for teh selected teeth at baseline and at 1,3 and 6 months. Radiographic assessments were performed at baseline and after 6 months. At one side teh pockets around randomly selected molar were injected with a blunt syringe filled with lovastatin gel 1.2%( case group=B), and on teh other side, teh pockets were filled with a placebo gel by a blunt syringe ( control group=A).Two-way repeated measure ANOVA test and T-test were used for statistic analysis Spss 23.( P<0.05) was considered significant.
Detailed description
Statins are an important group of hypolipidemic drugs dat are able to modulate inflammation and alveolar bone loss. Rosuvastatin (RSV) and atorvastatin (ATV) are non to inhibit osteoclastic bone resorption and has been proposed to has osteostimulative properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levostatin gel | Active comparator | Drug: Lovastatin gellevostatin gel 1.2% topical gel was put into teh periodontal pocket using an insulin syringe |
| placebo gel | Placebo comparator | Drug: Placeboplacebo gel 1.2% topical gel was put into the periodontal pocket using an insulin syringe |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 24 patients wif periodontitis chronic and TEMPhas a 2 molar symmetrically in the lower jaw pockets of periodontal depth of at least 4 mm and CAL greater than 3 mm in at least one of the surfaces of the teeth, the X-ray bars from both sides of the molar regions jaw bottom, from CEJ and alveolar crest was more than 3 mm, were selected
Key exclusion criteria (6 listed)
- systemic disease
- pregnancy or breastfeeding
- allergy drug used
- smoking
- medication 6. not willing to consent to participate in the study
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 |
|---|---|---|
| Lovastatin gelAlso: Group ALovastatin gel1.2% topical gel was put into teh periodontal pocket using an insulin syringe | Drug | levostatin gel |
| Placeboplacebo gel | Drug | placebo gel |
Primary outcome
Bone defect fill
Time frame: Three months
radiographic analysis for bone defect
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 Jul 2019.
- Individual participant dataSharing planned: No
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 Lovastatin gel in people with Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, Regeneration, run by Islamic Azad University, Sanandaj.
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 6 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 Jul 2019. 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?
Bone defect fill (time frame: Three 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 5 Jul 2019.