Immediate Implant PlacementPhase 2NCT04803500
Simvastatin Around Immediate Implant
A Phase 2 study testing Simvastatin in people with Immediate Implant Placement and Bone Regeneration, run by Ain Shams University.
Trial summary
The study evaluated the effect of local application of simvastatin around immediate implant on the amount of gap fill, ridge dimensional alterations and bone density in humans. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant Placement, Bone Regeneration, Alveolar Bone Resorption
- What is being tested?
- Simvastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2015to 3 May 2016
- Phase
- Phase 2
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between 20 and 50 years old
- requiring the extraction of 2 non-restorable maxillary canine or premolar on each side of the arch
- following extraction, the crestal bone had to be located 3 mm apical to the free gingival margin
- at least 3 mm of bone beyond the root apex was required to guarantee implant primary stability
Who cannot join
- unstable systemic diseases precluding surgical procedures
- compromised general health conditions that would impair bone healing including present history of bone irradiation, patient on bisphosphonates therapy, antitumor chemotherapy
- pregnancy
- compromised healing conditions e.g. uncontrolled diabetes mellitus
About this study
Official title: Restoration of Immediate Peri-implant Defect by Simvastatin: a Controlled Clinical and Cone Beam Computed Tomography Study
The study evaluated the effect of local application of simvastatin around immediate implant on the amount of gap fill, ridge dimensional alterations and bone density in humans.
- Being tested
- Simvastatin, Placebo
- Keywords
- Simvastatin, Immediate implant placement, gap distance, ridge dimension alteration, cone beam computed tomopgraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
single injection of simvastatin gel in the gap around immediately placed implant
PlaceboDrug
single injection of the solid lipid nanoparticle carrier in the gap around immediately placed implant
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin group | Active comparator | simvastatin gel (1.2 mg/0.1 ml of solid lipid nanoparticles) was locally applied to fill the jumping distance. Receives: Drug: Simvastatin |
| Control group | Placebo comparator | the solid lipid nanoparticles carrier was injected into the jumping distance. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of simvastatin on gap fill
using cone beam computed tomography
Measured: 3 months after implant placement
Effect of simvastatin on horizontal ridge dimension
using cone beam computed tomography
Measured: 3 months after implant placement
Effect of simvastatin on crestal bone level
using cone beam computed tomography
Measured: 3 months after implant placement
Effect of simvastatin on bone density
using cone beam computed tomography
Measured: 3 months after implant placement
Secondary outcomes (2)
Quality of wound healing
wound healing index
Measured: 1 week after implant placement
Quality of wound healing
wound healing index
Measured: 2 weeks after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start2 Apr 2015
- Primary completion15 Feb 2016
- Study completion3 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implant PlacementStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Split-mouth design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adel Rizk Botros, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803500
- Sponsor's protocol ID
- PER 15-1M
- Status last verified
- Mar 2021
- First submitted
- 7 Feb 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Immediate Peri-implant Defect by Simvastatin: a Controlled Clinical and Cone Beam Computed Tomography Study
- ClinicalTrials.gov ID
- NCT04803500
- Acronym / sponsor ID
- PER 15-1M
- Keywords
- Simvastatin, Immediate implant placement, gap distance, ridge dimension alteration, cone beam computed tomopgraphy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Apr 2015 (actual)
- Primary completion
- 15 Feb 2016 (actual)
- Study completion
- 3 May 2016 (actual)
- First posted
- 17 Mar 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 study evaluated the effect of local application of simvastatin around immediate implant on the amount of gap fill, ridge dimensional alterations and bone density in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth design
| Arm | Type | Receives |
|---|---|---|
| Simvastatin group | Active comparator | Drug: Simvastatinsimvastatin gel (1.2 mg/0.1 ml of solid lipid nanoparticles) was locally applied to fill the jumping distance. |
| Control group | Placebo comparator | Drug: Placebothe solid lipid nanoparticles carrier was injected into the jumping distance. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients between 20 and 50 years old
- requiring the extraction of 2 non-restorable maxillary canine or premolar on each side of the arch
- following extraction, the crestal bone had to be located 3 mm apical to the free gingival margin
- at least 3 mm of bone beyond the root apex was required to guarantee implant primary stability
Key exclusion criteria (4 listed)
- unstable systemic diseases precluding surgical procedures
- compromised general health conditions that would impair bone healing including present history of bone irradiation, patient on bisphosphonates therapy, antitumor chemotherapy
- pregnancy
- compromised healing conditions e.g. uncontrolled diabetes mellitus
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 |
|---|---|---|
| Simvastatinsingle injection of simvastatin gel in the gap around immediately placed implant | Drug | Simvastatin group |
| Placebosingle injection of the solid lipid nanoparticle carrier in the gap around immediately placed implant | Drug | Control group |
Primary outcome
Effect of simvastatin on gap fill
Time frame: 3 months after implant placement
using cone beam computed tomography
Effect of simvastatin on horizontal ridge dimension
Time frame: 3 months after implant placement
using cone beam computed tomography
Effect of simvastatin on crestal bone level
Time frame: 3 months after implant placement
using cone beam computed tomography
Effect of simvastatin on bone density
Time frame: 3 months after implant placement
using cone beam computed tomography
2 secondary outcomes
Quality of wound healing
Time frame: 1 week after implant placement
Quality of wound healing
Time frame: 2 weeks after implant placement
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 17 Mar 2021.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simvastatin in people with Immediate Implant Placement and Bone Regeneration, run by Ain Shams University.
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 4 inclusion and 4 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 17 Mar 2021. 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 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.
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?
Effect of simvastatin on gap fill (time frame: 3 months after implant placement). 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 17 Mar 2021.