PeriodontitisEarly Phase 1NCT04836078
Role of Simvastatin Microsponges in Treatment of Periodontitis
A Early Phase 1 study testing open flap subgingival debridement and Subgingival injection of chitosan 2% gel in people with Periodontitis, run by Assiut University at 1 site in Egypt.
Trial summary
the aim of our study is to enhance the dissolution and subsequently the local penetration of the drug through the sulcus in addition to controlling the drug release so that, the drug could be potentially absorbed. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- open flap subgingival debridement and Subgingival injection of chitosan 2% gel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2020to 10 Oct 2020
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Adult
Who may be able to join
- patients with chronic periodontitis with minimum two sites of pocket depth > 5 mm
- patients with normal lipid profile
- nonsmokers
- patients free from any systemic disorders
- committed patients to complete the treatment with follow-ups.
Who cannot join
- patients with hyperlipidemia
- patients taking lipid lowering drugs
- smokers
- pregnant
- Lactating women women, patients with mental or psychological illness and medically compromised patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance of Simvastatin Microsponges as a Local Treatment for Chronic Periodontitis - Randomized Clinical Trial
the aim of our study is to enhance the dissolution and subsequently the local penetration of the drug through the sulcus in addition to controlling the drug release so that, the drug could be potentially absorbed.
Read the detailed description
Patients will be divided randomly into three groups: Group (I);will be treated with subgingival debridement and subgengival injection of chitosan 2% gel containing a microsponges formulated (SV), Group (II); will be treated with subgingival debridement and subgingival injection of chitosan 2% gel containing free (SV) and Group (III); will be treated by subgingival debridement and placebo gel injected subgingivally. Pocket depth and clinical attachment loss bone gain were recorded preoperative and six months postoperative for all groups.
- Conditions
- Periodontitis
- Being tested
- open flap subgingival debridement, Subgingival injection of chitosan 2% gel
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open flap subgingival debridementProcedure or surgery
After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement.Randomization was then performed and concealment from the assessors.
Subgingival injection of chitosan 2% gelProcedure or surgery
Group (I); injected subgingivally with chitosan 2% gel containing a microsponges formulated drug weekly
Subgingival injection of chitosan 2% gelProcedure or surgery
Group (II); injected subgingivally with chitosan 2% gel containing free drug weekly
Subgingival injection of chitosan 2% gelProcedure or surgery
Group (III); injected subgingivally with placebo chitosan 2% gel weekly
| Study group | Role | What they receive |
|---|---|---|
| Plain chitosan gel group | Placebo comparator | After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement . Randomization will be performed and concealment from the assessors. For root conditioning purpose, Group (I) ; will be injected subgingivally with chitosan 2% gel . Receives: Procedure: open flap subgingival debridement; Procedure: Subgingival injection of chitosan 2% gel |
| Chitosan gels containing free Simvastatin | Active comparator | Will be injected subgingivally with simvastatin microsponges dispersed into chitosan 2% gel. . Receives: Procedure: open flap subgingival debridement; Procedure: Subgingival injection of chitosan 2% gel |
| Chitosan gels containing Simvastatin microsponges | Experimental | This group will be injected subgingivally with free simvastatin dispersed into chitosan 2% gel containing . Receives: Procedure: open flap subgingival debridement; Procedure: Subgingival injection of chitosan 2% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket depth
Will be measured in millimetre
Measured: Before the beginning of study
Pocket depth
Will be measured in millimetre
Measured: By the end of study after 6 months of 6 months
Clinical attachment loss
Will be measured in millimetre
Measured: Before beginning of the study
Clinical attachment loss
Will be measured in millimetre
Measured: By the end of study after 6 months of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start10 Feb 2020
- Primary completion10 Aug 2020
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mortada, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836078
- Sponsor's protocol ID
- Simvastatin in periodontitis
- Status last verified
- Apr 2021
- First submitted
- 25 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Simvastatin Microsponges as a Local Treatment for Chronic Periodontitis - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04836078
- Acronym / sponsor ID
- Simvastatin in periodontitis
- Conditions
- Periodontitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 8 Apr 2021 (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.
the aim of our study is to enhance the dissolution and subsequently the local penetration of the drug through the sulcus in addition to controlling the drug release so that, the drug could be potentially absorbed.
Detailed description
Patients will be divided randomly into three groups: Group (I);will be treated with subgingival debridement and subgengival injection of chitosan 2% gel containing a microsponges formulated (SV), Group (II); will be treated with subgingival debridement and subgingival injection of chitosan 2% gel containing free (SV) and Group (III); will be treated by subgingival debridement and placebo gel injected subgingivally. Pocket depth and clinical attachment loss bone gain were recorded preoperative and six months postoperative for all groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Plain chitosan gel group | Placebo comparator | Procedure: open flap subgingival debridement, Procedure: Subgingival injection of chitosan 2% gelAfter the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement . Randomization will be performed and concealment from the assessors. For root conditioning purpose, Group (I) ; will be injected subgingivally with chitosan 2% gel . |
| Chitosan gels containing free Simvastatin | Active comparator | Procedure: open flap subgingival debridement, Procedure: Subgingival injection of chitosan 2% gelWill be injected subgingivally with simvastatin microsponges dispersed into chitosan 2% gel. . |
| Chitosan gels containing Simvastatin microsponges | Experimental | Procedure: open flap subgingival debridement, Procedure: Subgingival injection of chitosan 2% gelThis group will be injected subgingivally with free simvastatin dispersed into chitosan 2% gel containing . |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- patients with chronic periodontitis with minimum two sites of pocket depth > 5 mm
- patients with normal lipid profile
- nonsmokers
- patients free from any systemic disorders
- committed patients to complete the treatment with follow-ups.
Key exclusion criteria (5 listed)
- patients with hyperlipidemia
- patients taking lipid lowering drugs
- smokers
- pregnant
- Lactating women women, patients with mental or psychological illness and medically compromised patients.
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 |
|---|---|---|
| open flap subgingival debridementAfter the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement.Randomization was then performed and concealment from the assessors. | Procedure or surgery | Chitosan gels containing Simvastatin microsponges, Chitosan gels containing free Simvastatin, Plain chitosan gel group |
| Subgingival injection of chitosan 2% gelGroup (I); injected subgingivally with chitosan 2% gel containing a microsponges formulated drug weekly | Procedure or surgery | Plain chitosan gel group |
| Subgingival injection of chitosan 2% gelGroup (II); injected subgingivally with chitosan 2% gel containing free drug weekly | Procedure or surgery | Chitosan gels containing free Simvastatin |
| Subgingival injection of chitosan 2% gelGroup (III); injected subgingivally with placebo chitosan 2% gel weekly | Procedure or surgery | Chitosan gels containing Simvastatin microsponges |
Primary outcome
Pocket depth
Time frame: Before the beginning of study
Will be measured in millimetre
Pocket depth
Time frame: By the end of study after 6 months of 6 months
Will be measured in millimetre
Clinical attachment loss
Time frame: Before beginning of the study
Will be measured in millimetre
Clinical attachment loss
Time frame: By the end of study after 6 months of 6 months
Will be measured in millimetre
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 8 Apr 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing open flap subgingival debridement and Subgingival injection of chitosan 2% gel in people with Periodontitis, run by Assiut University at 1 site in Egypt.
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 5 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 8 Apr 2021. 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 Egypt. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Pocket depth (time frame: Before the beginning of study). The study lists 4 primary outcomes in all. 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 8 Apr 2021.