Autogenous Tooth Bone GraftNCT04992416
Immediately Placed Implants Using Simvastatin and Autogenous Tooth Graft Combination in Periodontally Compromised Sites
A study testing immediate implant placement with ATBG and SMV and immediate implant placement with ATBG in people with Autogenous Tooth Bone Graft and Immediate Implant Placement, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Recently, autogenous tooth graft (ATG) made from compromised teeth was applied in bone defects and resulted in a good clinical efficacy.(6) Moreover, it is more accepted by patients to use extracted teeth as a bone graft material, especially in the case of immediate implant placement. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Autogenous Tooth Bone Graft, Immediate Implant Placement, Simvastatin
- What is being tested?
- immediate implant placement with ATBG and SMV and immediate implant placement with ATBG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Sep 2021to 15 Dec 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Teeth need to be extracted for periodontal reasons with a defect of labial bone (horizontal or vertical bone defect).
- the teeth without acute inflammation.
- no uncontrolled systemic disease which is not suitable for implantation.
- Good systemic and oral health.
Who cannot join
- patients with systemic diseases or medications known to alter healing processes.
- Psychiatric disorders.
- Root canal treated teeth.
- patients undergoing or who had undergone radiation therapy and chemotherapy to the head and neck region during 12 months.
- patients with para-functional habits.
- alcoholics.
- drug abusers.
- heavy smokers
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: Immediately Placed Implants Using Simvastatin and Autogenous Tooth Graft Combination in Periodontally Compromised Sites: A Randomized Controlled Clinical Trial
Recently, autogenous tooth graft (ATG) made from compromised teeth was applied in bone defects and resulted in a good clinical efficacy.(6) Moreover, it is more accepted by patients to use extracted teeth as a bone graft material, especially in the case of immediate implant placement. Simvastatin (SMV), known as a 3-hydroxy-3-methylglutaryl-CoA (HMG-CoA) reductase inhibitor, is widely used to decrease serum cholesterol because of its safe and effective treatment. Apart from cholesterol-lowering effects, SMV is also found to promote osteogenic differentiation of bone marrow stem cells (BMSCs), suppress osteoclastic differentiation in bone tissue and promotes osseointegration around implants in animal studies. SMV is reported to enhance autophagy and alleviates the ROS of BMSCs in the osseointegration of implants. The present study will be carried out to evaluate the effect of SMV combined with ATG on bone formation around immediately placed dental implants.
- Being tested
- immediate implant placement with ATBG and SMV, immediate implant placement with ATBG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant placement with ATBG and SMVProcedure or surgery
immediate implant placement using ATBG as a graft material, with SMV
immediate implant placement with ATBGProcedure or surgery
immediate implant placement using ATBG as a graft material without SMV
| Study group | Role | What they receive |
|---|---|---|
| SMV with ATBG around implant | Experimental | SMV mixed with ATBG around immediately placed dental implants in the extraction sockets Receives: Procedure: immediate implant placement with ATBG and SMV |
| ATBG around implant | Active comparator | ATBG around immediately placed dental implants in the extraction sockets Receives: Procedure: immediate implant placement with ATBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical evaluation of bone formation around immediately placed dental implants
Changes on bone formation using ATBG with or without SMV around immediately placed dental implants in periodontally compromised teeth
Measured: 9 months
radiographic outcome around immediately placed dental implants
the radiographic outcome of ATBG on bone formation with or without SMV around immediately placed dental implants in periodontally compromised teeth
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 posted5 Aug 2021
- Study start2 Sep 2021
- Primary completion10 Dec 2022
- Study completion15 Dec 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 Autogenous Tooth Bone GraftStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 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
- NCT04992416
- Sponsor's protocol ID
- KFSIRB200-27
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2021
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Issa DR, Nassar M, Elamrousy W. Immediately placed implants using simvastatin and autogenous tooth graft combination in periodontally compromised sites: a randomized controlled clinical trial. Clin Oral Investig. 2024 Mar 12;28(4):210. doi: 10.1007/s00784-024-05596-4.
PubMed 38467945
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediately Placed Implants Using Simvastatin and Autogenous Tooth Graft Combination in Periodontally Compromised Sites: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04992416
- Acronym / sponsor ID
- KFSIRB200-27
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 5 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.
Recently, autogenous tooth graft (ATG) made from compromised teeth was applied in bone defects and resulted in a good clinical efficacy.(6) Moreover, it is more accepted by patients to use extracted teeth as a bone graft material, especially in the case of immediate implant placement. Simvastatin (SMV), known as a 3-hydroxy-3-methylglutaryl-CoA (HMG-CoA) reductase inhibitor, is widely used to decrease serum cholesterol because of its safe and effective treatment. Apart from cholesterol-lowering effects, SMV is also found to promote osteogenic differentiation of bone marrow stem cells (BMSCs), suppress osteoclastic differentiation in bone tissue and promotes osseointegration around implants in animal studies. SMV is reported to enhance autophagy and alleviates the ROS of BMSCs in the osseointegration of implants. The present study will be carried out to evaluate the effect of SMV combined with ATG on bone formation around immediately placed dental implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMV with ATBG around implant | Experimental | Procedure: immediate implant placement with ATBG and SMVSMV mixed with ATBG around immediately placed dental implants in the extraction sockets |
| ATBG around implant | Active comparator | Procedure: immediate implant placement with ATBGATBG around immediately placed dental implants in the extraction sockets |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Teeth need to be extracted for periodontal reasons with a defect of labial bone (horizontal or vertical bone defect).
- the teeth without acute inflammation.
- no uncontrolled systemic disease which is not suitable for implantation.
- Good systemic and oral health.
Key exclusion criteria (8 listed)
- patients with systemic diseases or medications known to alter healing processes.
- Psychiatric disorders.
- Root canal treated teeth.
- patients undergoing or who had undergone radiation therapy and chemotherapy to the head and neck region during 12 months.
- patients with para-functional habits.
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 with ATBG and SMVimmediate implant placement using ATBG as a graft material, with SMV | Procedure or surgery | SMV with ATBG around implant |
| immediate implant placement with ATBGimmediate implant placement using ATBG as a graft material without SMV | Procedure or surgery | ATBG around implant |
Primary outcome
clinical evaluation of bone formation around immediately placed dental implants
Time frame: 9 months
Changes on bone formation using ATBG with or without SMV around immediately placed dental implants in periodontally compromised teeth
radiographic outcome around immediately placed dental implants
Time frame: 9 months
the radiographic outcome of ATBG on bone formation with or without SMV around immediately placed dental implants in periodontally compromised teeth
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 31 Aug 2023.
- Derived from this study: PubMed 38467945Issa DR, Nassar M, Elamrousy W. Immediately placed implants using simvastatin and autogenous tooth graft combination in periodontally compromised sites: a randomized controlled clinical trial. Clin Oral Investig. 2024 Mar 12;28(4):210. doi: 10.1007/s00784-024-05596-4.
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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 with ATBG and SMV and immediate implant placement with ATBG in people with Autogenous Tooth Bone Graft and Immediate Implant Placement, 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 4 inclusion and 8 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 31 Aug 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?
clinical evaluation of bone formation around immediately placed dental implants (time frame: 9 months). The study lists 2 primary outcomes in all. 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 NCT04992416, 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 31 Aug 2023.