Platelet-rich FibrinPhase 1NCT05008068
Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes
A Phase 1 study testing Simvastatin in people with Platelet-rich Fibrin and Simvastatin, run by British University In Egypt at 1 site in Egypt.
Trial summary
ACKGROUND: Simvastatin (SIM), a pharmacological drug used for hypercholesterolemia, has been found to have pleotropic effects on bones. Simvastatin together with the appropriate carrier may decrease bone loss around implants. Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet-rich Fibrin, Simvastatin
- What is being tested?
- Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Aug 2019to 12 Sep 2020
- 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 45 to 60 years
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with a partially edentulous mandible indicated for rehabilitation with implant prostheses,
- any extractions, or surgeries performed at least six 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 such as psychologically unstable patients
Trial locations and contacts
1 site in 1 country.
About this study
ACKGROUND: Simvastatin (SIM), a pharmacological drug used for hypercholesterolemia, has been found to have pleotropic effects on bones. Simvastatin together with the appropriate carrier may decrease bone loss around implants.
PURPOSE: To compare the long term effects of autologous PRF alone, and PRF loaded with SIM on peri-implant bone changes and implant stability in patients undergoing implant rehabilitation.
MATERIALS AND METHODS: A randomized controlled split-mouth studyincluding 8 males between the ages of 45-60 years. Each patient received two implants, one on each side of the arch. One side was treated with PRF alone and the other side with PRF +Simvastatin, at the time of Osteotomy. A cone-beam CT was used to evaluate bone changes around the insertion of implant sites atthree, six, and twelve months postoperatively. The secondary outcome included measuring implant stability using Ostell device at baseline and 3 months post insertion. To compare groups at different time periods, data was examined using a two-way (ANOVA) analysis.
- Conditions
- Platelet-rich Fibrin, Simvastatin
- Being tested
- Simvastatin
- Keywords
- Platelet-rich fibrin, Simvastatin, Bone loss, Peri-implant Bone Changes
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Simvastatin with PRF at site of osteotome
| Study group | Role | What they receive |
|---|---|---|
| PRF alone | Experimental | Not described Receives: Drug: Simvastatin |
| PRF in addition to Simvastatin | Active comparator | Not described Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurement of bone thickness
Measuring unit in millimeters , measuring device is CBCT software
Measured: After 3 months of the osteotomy and application of Simvastatin
The measurement of bone thickness
Measuring unit in millimeters , measuring device is CBCT software
Measured: After 6 months of the osteotomy and application of Simvastatin
The measurement of bone thickness
Measuring unit in millimeters , measuring device is CBCT software
Measured: After 12 months of the osteotomy and application of Simvastatin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start12 Aug 2019
- Primary completion12 Sep 2020
- Study completion12 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet-rich FibrinStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Each patient received two implants, one on each side of the arch. One side was treated with PRF alone and the other side with PRF +Simvastatin, at the time of Osteotomy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Fikry El Shafei, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008068
- Sponsor's protocol ID
- 0012490
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 17 Aug 2021
- 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 17 Aug 2021. 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 on Peri-implant Bone Changes
- ClinicalTrials.gov ID
- NCT05008068
- Acronym / sponsor ID
- 0012490
- Conditions
- Platelet-rich Fibrin, Simvastatin
- Keywords
- Platelet-rich fibrin, Simvastatin, Bone loss, Peri-implant Bone Changes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 12 Sep 2020 (actual)
- Study completion
- 12 Sep 2020 (actual)
- First posted
- 17 Aug 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.
ACKGROUND: Simvastatin (SIM), a pharmacological drug used for hypercholesterolemia, has been found to have pleotropic effects on bones. Simvastatin together with the appropriate carrier may decrease bone loss around implants.
PURPOSE: To compare the long term effects of autologous PRF alone, and PRF loaded with SIM on peri-implant bone changes and implant stability in patients undergoing implant rehabilitation.
MATERIALS AND METHODS: A randomized controlled split-mouth studyincluding 8 males between the ages of 45-60 years. Each patient received two implants, one on each side of the arch. One side was treated with PRF alone and the other side with PRF +Simvastatin, at the time of Osteotomy. A cone-beam CT was used to evaluate bone changes around the insertion of implant sites atthree, six, and twelve months postoperatively. The secondary outcome included measuring implant stability using Ostell device at baseline and 3 months post insertion. To compare groups at different time periods, data was examined using a two-way (ANOVA) analysis.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Each patient received two implants, one on each side of the arch. One side was treated with PRF alone and the other side with PRF +Simvastatin, at the time of Osteotomy.
| Arm | Type | Receives |
|---|---|---|
| PRF alone | Experimental | Drug: Simvastatin |
| PRF in addition to Simvastatin | Active comparator | Drug: Simvastatin |
Who may qualify
- Ages
- 45 to 60 years
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients with a partially edentulous mandible indicated for rehabilitation with implant prostheses,
- any extractions, or surgeries performed at least six 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 |
|---|---|---|
| SimvastatinSimvastatin with PRF at site of osteotome | Drug | PRF alone, PRF in addition to Simvastatin |
Primary outcome
The measurement of bone thickness
Time frame: After 3 months of the osteotomy and application of Simvastatin
Measuring unit in millimeters , measuring device is CBCT software
The measurement of bone thickness
Time frame: After 6 months of the osteotomy and application of Simvastatin
Measuring unit in millimeters , measuring device is CBCT software
The measurement of bone thickness
Time frame: After 12 months of the osteotomy and application of Simvastatin
Measuring unit in millimeters , measuring device is CBCT software
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 Aug 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 Phase 1 study testing Simvastatin in people with Platelet-rich Fibrin and Simvastatin, 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 2 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 17 Aug 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. 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?
The measurement of bone thickness (time frame: After 3 months of the osteotomy and application of Simvastatin). 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 17 Aug 2021.