PeriodontitisPhase 1NCT05583643
Clinical & Biochemical Effect of Atorvastatin in Nano Particles Gel in Periodontitis Treatment
A Phase 1 study testing Atorvastatin Calcium and Scaling and debridement only in people with Periodontitis, run by Misr University for Science and Technology at 1 site in Egypt.
Trial summary
Periodontitis is a destructive chronic inflammatory disease characterized by periodontium damage and pocket formation between the tooth and the gingival margin resulting in ultimate tooth loss. Various topical anti-inflammatory drugs were used to treat inflammation in periodontitis. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Atorvastatin Calcium and Scaling and debridement only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Dec 2021to 30 Jun 2022
- Phase
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy patients
- Patients with moderate periodontitis
Who cannot join
- Pregnant women
- Lactating women
- Patients with chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Syringeable Atorvastatin Loaded Eugenol Enriched PEGylated Cubosomes In-situ Gel for the Intra-pocket Treatment of Periodontitis: Statistical Optimization and Clinical Assessment
Periodontitis is a destructive chronic inflammatory disease characterized by periodontium damage and pocket formation between the tooth and the gingival margin resulting in ultimate tooth loss. Various topical anti-inflammatory drugs were used to treat inflammation in periodontitis. Introducing atorvastatin as a novel remedy for periodontitis treatment necessitates developing a syringeable modified delivery system capable of targeting inflammation within the periodontal pockets.
- Conditions
- Periodontitis
- Being tested
- Atorvastatin Calcium, Scaling and debridement only
- Keywords
- Periodontitis, Non-surgical treatment, Atorvastatin, Phase 1 therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin CalciumDrug
Atorvastatin loaded into nano particles in-situ gel adjunctive to scaling and debridement
Atorvastatin CalciumDrug
Atorvastatin loaded into in-situ gel adjunctive to scaling and debridement
Scaling and debridement onlyOther
Scaling and debridement only
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 therapy | Other | Not described Receives: Other: Scaling and debridement only |
| Phase 1 therapy with atorvastatin loaded into cubosomal in-situ gel | Active comparator | Not described Receives: Drug: Atorvastatin Calcium |
| Phase 1 therapy with atorvastatin loaded into in-situ gel | Active comparator | Not described Receives: Drug: Atorvastatin Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
Measured: 6 weeks
Bleeding index
Measured: 6 weeks
Plaque index
Measured: 6 weeks
Secondary outcomes (1)
Assessment of transforming growth factor in gingival crevicular fluid
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start7 Dec 2021
- Primary completion15 Apr 2022
- Study completion30 Jun 2022
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Amin Elgendy, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583643
- Sponsor's protocol ID
- FWA00025577
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 19 Oct 2022
- 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 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Syringeable Atorvastatin Loaded Eugenol Enriched PEGylated Cubosomes In-situ Gel for the Intra-pocket Treatment of Periodontitis: Statistical Optimization and Clinical Assessment
- ClinicalTrials.gov ID
- NCT05583643
- Acronym / sponsor ID
- FWA00025577
- Conditions
- Periodontitis
- Keywords
- Periodontitis, Non-surgical treatment, Atorvastatin, Phase 1 therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 18 Oct 2022 (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.
Periodontitis is a destructive chronic inflammatory disease characterized by periodontium damage and pocket formation between the tooth and the gingival margin resulting in ultimate tooth loss. Various topical anti-inflammatory drugs were used to treat inflammation in periodontitis. Introducing atorvastatin as a novel remedy for periodontitis treatment necessitates developing a syringeable modified delivery system capable of targeting inflammation within the periodontal pockets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 therapy | Other | Other: Scaling and debridement only |
| Phase 1 therapy with atorvastatin loaded into cubosomal in-situ gel | Active comparator | Drug: Atorvastatin Calcium |
| Phase 1 therapy with atorvastatin loaded into in-situ gel | Active comparator | Drug: Atorvastatin Calcium |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Systemically healthy patients
- Patients with moderate periodontitis
Key exclusion criteria (3 listed)
- Pregnant women
- Lactating women
- Patients with chronic diseases
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 |
|---|---|---|
| Atorvastatin CalciumAtorvastatin loaded into nano particles in-situ gel adjunctive to scaling and debridement | Drug | Phase 1 therapy with atorvastatin loaded into cubosomal in-situ gel |
| Atorvastatin CalciumAtorvastatin loaded into in-situ gel adjunctive to scaling and debridement | Drug | Phase 1 therapy with atorvastatin loaded into in-situ gel |
| Scaling and debridement onlyScaling and debridement only | Other | Phase 1 therapy |
Primary outcome
Probing depth
Time frame: 6 weeks
Bleeding index
Time frame: 6 weeks
Plaque index
Time frame: 6 weeks
1 secondary outcome
Assessment of transforming growth factor in gingival crevicular fluid
Time frame: 6 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 19 Oct 2022.
- 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 Phase 1 study testing Atorvastatin Calcium and Scaling and debridement only in people with Periodontitis, run by Misr University for Science and Technology 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 2 inclusion and 3 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 Oct 2022. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Probing depth (time frame: 6 weeks). The study lists 3 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 19 Oct 2022.