Ridge SplittingNCT05020405
The Effect of Simvastatin With Guided Bone Regeneration in Ridge Splitting and Simultaneously Implantation
A study testing Immediate implant placement and ARS with GBR and SMV and Immediate implant placement and ARS with GBR in people with Ridge Splitting and Simvastatin, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Ridge split augmentation technique, with immediate implant placement, reduces the time of the treatment and the time of the final prosthetic reconstruction. Furthermore, compression of the bone increases its density. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ridge Splitting, Simvastatin, Immediate Implant
- What is being tested?
- Immediate implant placement and ARS with GBR and SMV and Immediate implant placement and ARS with GBR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 20 Feb 2022
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good general health at the time of surgery.
- at least 3 months of healing after tooth extraction.
- horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide.
Who cannot join
- a vertical bone defect in the edentulous ridge.
- thick cortex in the labial/buccal with less cancellous bone inside
- obvious undercut on the labial/buccal side.
- uncontrolled periodontal conditions or other oral disorders.
- history of radiotherapy in the head and neck region.
- uncontrolled diabetes mellitus or other systematic disorders.
Show all 10Show fewer
- smokers.
- Pregnancy.
- non-compliant patients.
- allergic reaction to the medications used.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Kafrelsheikh University
Kafr ash Shaykh, 33511
About this study
Official title: The Effect of Simvastatin With Guided Bone Regeneration on Ridge Volume in Ridge Splitting and Simultaneously Implantation: a Randomized Clinical Trial
Ridge split augmentation technique, with immediate implant placement, reduces the time of the treatment and the time of the final prosthetic reconstruction. Furthermore, compression of the bone increases its density. SMV is also found to promote osteogenic differentiation of bone marrow stem cells, suppress osteoclastic differentiation in bone tissue, and promotes osseointegration around implants in animal studies. The aim of this study is to compare surgical outcomes of the application of the alveolar ridge splitting (ARS) in combination with guided bone regeneration (GBR) using bone grafting and a barrier membrane, associated with immediate implant placement versus ARS in combination with the use of SMV with GBR using bone grafting and a barrier membrane, associated with immediate implant placement in patients with horizontally atrophic jaw bones.
- Conditions
- Ridge Splitting, Simvastatin, Immediate Implant
- Being tested
- Immediate implant placement and ARS with GBR and SMV, Immediate implant placement and ARS with GBR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant placement and ARS with GBR and SMVProcedure or surgery
Implant insertion and GBR for augmentation of the gap between buccal and lingual plate using bone graft mixed with SMV
Immediate implant placement and ARS with GBRProcedure or surgery
Implant insertion and GBR for augmentation of the gap between buccal and lingual plate
| Study group | Role | What they receive |
|---|---|---|
| ARS with GBR and SMV | Experimental | alveolar ridge splitting in combination with the use of GBR with SMV with immediate implant placement Receives: Procedure: Immediate implant placement and ARS with GBR and SMV |
| alveolar ridge splitting with GBR | Active comparator | alveolar ridge splitting in combination with the use of GBR without SMV with immediate implant placement Receives: Procedure: Immediate implant placement and ARS with GBR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of the amount of bone formation in millimeters around immediately placed dental implants
Measurements of the amount of bone formation in millimeters using GBR with or without the combined effect of SMV in the ridge splitting following immediate implant placement.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Oct 2020
- Primary completion12 Feb 2022
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ridge SplittingStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Rasheed Issa, Kafrelsheikh University
- Investigators
- Dalia R Issa, PhD, Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020405
- Sponsor's protocol ID
- KFSIRB200- 22
- Status last verified
- Jul 2023
- First submitted
- 18 Aug 2021
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Issa DR, Elamrousy W, Gamal AY. Alveolar ridge splitting and simvastatin loaded xenograft for guided bone regeneration and simultaneous implant placement: randomized controlled clinical trial. Clin Oral Investig. 2024 Jan 4;28(1):71. doi: 10.1007/s00784-023-05427-y.
PubMed 38172458
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simvastatin With Guided Bone Regeneration on Ridge Volume in Ridge Splitting and Simultaneously Implantation: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05020405
- Acronym / sponsor ID
- KFSIRB200- 22
- Conditions
- Ridge Splitting, Simvastatin, Immediate Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 12 Feb 2022 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 25 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.
Ridge split augmentation technique, with immediate implant placement, reduces the time of the treatment and the time of the final prosthetic reconstruction. Furthermore, compression of the bone increases its density. SMV is also found to promote osteogenic differentiation of bone marrow stem cells, suppress osteoclastic differentiation in bone tissue, and promotes osseointegration around implants in animal studies. The aim of this study is to compare surgical outcomes of the application of the alveolar ridge splitting (ARS) in combination with guided bone regeneration (GBR) using bone grafting and a barrier membrane, associated with immediate implant placement versus ARS in combination with the use of SMV with GBR using bone grafting and a barrier membrane, associated with immediate implant placement in patients with horizontally atrophic jaw bones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARS with GBR and SMV | Experimental | Procedure: Immediate implant placement and ARS with GBR and SMValveolar ridge splitting in combination with the use of GBR with SMV with immediate implant placement |
| alveolar ridge splitting with GBR | Active comparator | Procedure: Immediate implant placement and ARS with GBRalveolar ridge splitting in combination with the use of GBR without SMV with immediate implant placement |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- good general health at the time of surgery.
- at least 3 months of healing after tooth extraction.
- horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide.
Key exclusion criteria (10 listed)
- a vertical bone defect in the edentulous ridge.
- thick cortex in the labial/buccal with less cancellous bone inside
- obvious undercut on the labial/buccal side.
- uncontrolled periodontal conditions or other oral disorders.
- history of radiotherapy in the head and neck region.
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 |
|---|---|---|
| Immediate implant placement and ARS with GBR and SMVImplant insertion and GBR for augmentation of the gap between buccal and lingual plate using bone graft mixed with SMV | Procedure or surgery | ARS with GBR and SMV |
| Immediate implant placement and ARS with GBRImplant insertion and GBR for augmentation of the gap between buccal and lingual plate | Procedure or surgery | alveolar ridge splitting with GBR |
Primary outcome
Measurements of the amount of bone formation in millimeters around immediately placed dental implants
Time frame: 9 months
Measurements of the amount of bone formation in millimeters using GBR with or without the combined effect of SMV in the ridge splitting following immediate 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 18 Jul 2023.
- Derived from this study: PubMed 38172458Issa DR, Elamrousy W, Gamal AY. Alveolar ridge splitting and simvastatin loaded xenograft for guided bone regeneration and simultaneous implant placement: randomized controlled clinical trial. Clin Oral Investig. 2024 Jan 4;28(1):71. doi: 10.1007/s00784-023-05427-y.
Related trials for Ridge Splitting
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Outcomes of Ridge Splitting Versus Sausage Technique
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Clinical and Radiographic Evaluation of Ridge Splitting With Simultaneous Implant Placement Covered With Concentrated Growth Factor Membranes in Narrow Alveolar Ridge
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Computer Guided Modified Ridge Splitting Versus Free Hand Technique in Horizontal Deficiency in Posterior Mandible
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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.
Dalia R Issa, PhD principal investigator
Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implant placement and ARS with GBR and SMV and Immediate implant placement and ARS with GBR in people with Ridge Splitting and Simvastatin, run by Kafrelsheikh 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 3 inclusion and 10 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 18 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Measurements of the amount of bone formation in millimeters around immediately placed dental implants (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05020405, which also lists 1 linked publication.
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 18 Jul 2023.