Dental Caries Extending to PulpPhase 1/2NCT06016218
Effect of Local Application of Simvastatin Versus Bone Powder on Implant Bone Changes
A Phase 1/2 study testing Simvastatin in people with Dental Caries Extending to Pulp and Dental Implant Failed, run by British University In Egypt at 1 site in Egypt.
Trial summary
This study is conducted A- To investigate that PRF loaded with osteopromotive pharmacological drug can be a great aid in implant rehabilitation, and whether it could be a replacement for the other high price bone graft materials or not. This will be done through: 1. Read more about this study
- Who is it for?
- Ages 45 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Caries Extending to Pulp, Dental Implant Failed
- What is being tested?
- Simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2021to 5 Feb 2023
- Phase
- Phase 1/2
- 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 45 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Badly Broken Down Tooth requiring extraction
- Medically Free
- Any other procedures or surgeries were performed 6 months earlier
Who cannot join
- patients with systemic diseases affecting bone quality or resorption
- temporomandibular joint dysfunction
- severe attrition or parafunctional habits
- patients undergoing radiotherapy or chemotherapy
- heavy smokers
- vulnerable groups like psychologically unstable patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Local Application of Platelet-Rich Fibrin Scaffold Loaded With Simvastatin Versus Bone Powder on Peri-Implant Bone Changes
This study is conducted A- To investigate that PRF loaded with osteopromotive pharmacological drug can be a great aid in implant rehabilitation, and whether it could be a replacement for the other high price bone graft materials or not.
This will be done through:
- Measuring bone changes around the implant by cone beam
- Measuring change in bone density around the implants
B- Evaluate the effect of statins on osteoblasts activity and expression of various osteogenic products in vitro.
Read the detailed description
Twenty four patients requiring rehabilitation by immediate implantation in an extraction socket were recruited for this study. The Patients were divided into three groups (n=8), For the first group; immediately after extraction, PRF alone was added into the extraction socket prior to implant insertion. For the second group, PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion. For the third Group; PRF + Bone powder are inserted into the extraction site before implant insertion. A conebeam CT was used to evaluate the effect on bone changes and bone density around implant sites, for every patient in all implant groups immediately after the surgery and at follow-up time. In vitro experiment: isolation of human Adipose mesenchymal stem cells (hAd-MSCs), characterization and osteogenic differentiation will be done. The cells were divided into two groups one control group and the other statin group. Osteogenic markers were measured in both groups and statistical analysis performed
- Being tested
- Simvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone
| Study group | Role | What they receive |
|---|---|---|
| PRF | Placebo comparator | PRF alone was added to extraction site prior to implant insertion Receives: Drug: Simvastatin |
| SIM+ PRF | Active comparator | PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion Receives: Drug: Simvastatin |
| BO+ PRF | Active comparator | PRF + Bone powder are inserted into the extraction site before implant insertion. Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in crestal peri-imlant Bone
Radiographic evaluation of crestal bone changes around the studied implants
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start5 Jan 2021
- Primary completion5 Jan 2022
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries Extending to PulpStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016218
- Sponsor's protocol ID
- 260981
- Status last verified
- Aug 2023
- First submitted
- 12 Jun 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Application of Platelet-Rich Fibrin Scaffold Loaded With Simvastatin Versus Bone Powder on Peri-Implant Bone Changes
- ClinicalTrials.gov ID
- NCT06016218
- Acronym / sponsor ID
- 260981
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 29 Aug 2023 (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.
This study is conducted A- To investigate that PRF loaded with osteopromotive pharmacological drug can be a great aid in implant rehabilitation, and whether it could be a replacement for the other high price bone graft materials or not.
This will be done through:
- Measuring bone changes around the implant by cone beam
- Measuring change in bone density around the implants
B- Evaluate the effect of statins on osteoblasts activity and expression of various osteogenic products in vitro.
Detailed description
Twenty four patients requiring rehabilitation by immediate implantation in an extraction socket were recruited for this study. The Patients were divided into three groups (n=8), For the first group; immediately after extraction, PRF alone was added into the extraction socket prior to implant insertion. For the second group, PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion. For the third Group; PRF + Bone powder are inserted into the extraction site before implant insertion. A conebeam CT was used to evaluate the effect on bone changes and bone density around implant sites, for every patient in all implant groups immediately after the surgery and at follow-up time. In vitro experiment: isolation of human Adipose mesenchymal stem cells (hAd-MSCs), characterization and osteogenic differentiation will be done. The cells were divided into two groups one control group and the other statin group. Osteogenic markers were measured in both groups and statistical analysis performed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRF | Placebo comparator | Drug: SimvastatinPRF alone was added to extraction site prior to implant insertion |
| SIM+ PRF | Active comparator | Drug: SimvastatinPRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion |
| BO+ PRF | Active comparator | Drug: SimvastatinPRF + Bone powder are inserted into the extraction site before implant insertion. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Badly Broken Down Tooth requiring extraction
- Medically Free
- Any other procedures or surgeries were performed 6 months earlier
Key exclusion criteria (6 listed)
- patients with systemic diseases affecting bone quality or resorption
- temporomandibular joint dysfunction
- severe attrition or parafunctional habits
- patients undergoing radiotherapy or chemotherapy
- heavy smokers
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 |
|---|---|---|
| SimvastatinComparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone | Drug | BO+ PRF, PRF, SIM+ PRF |
Primary outcome
Changes in crestal peri-imlant Bone
Time frame: 12 months
Radiographic evaluation of crestal bone changes around the studied implants
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 6 Sep 2023.
- 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 1/2 study testing Simvastatin in people with Dental Caries Extending to Pulp and Dental Implant Failed, run by British University In Egypt 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 3 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 6 Sep 2023. 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 combined 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.
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?
Changes in crestal peri-imlant Bone (time frame: 12 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 6 Sep 2023.