Alveolar Ridge PreservationARPNCT06879171
Radiographic and Histomorphometric Assessment for Alveolar Ridge Preservation Using Autogenous Tooth Graft From Extracted Tooth Combined With Simvastatin 1:1 Versus Autogenous Tooth Graft
A study testing Alveolar ridge preservation in people with Alveolar Ridge Preservation and Horizontal Alveolar Bone Loss, run by Cairo University.
Trial summary
This study will be held to overcome the previous limitations related to bone loss after teeth extraction by taking advantages from both Autogenous tooth graft and Simvastatin which will offer a promising synergistic approach for reducing alveolar ridge resorption, enhance bone regeneration and ensuring implant site… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Alveolar Ridge Preservation, Horizontal Alveolar Bone Loss, Vertical Alveolar Bone Loss
- What is being tested?
- Alveolar ridge preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2025to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with badly broken, non-restorable, or periodontally hopeless non molar single rooted teeth.
- Age from 20-45 years old(6,13). No sex predilection.
- Medically free from any medical condition that would interfere with bone healing.
- Patients with status classification (ASA I \& II) with adequate oral hygiene condition.
- Alveolar sockets free from any preexisting periapical pathology based on intraoral periapical or panoramic radiograph.
Who cannot join
- Patients with any medical condition that contraindicated the procedure and general contraindications for Implant Surgery(6,13)
- Patients who are allergic to Simvastatin drug.(6)
- Presence of active infection around the tooth or remaining root.
- Psychological reasons that might affect the procedure or the subsequent follow up visits.
- Heavy smokers
- Immunosuppressed or Immunocompromised.(13)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Nourhan Mohamed Abd Elwahab, Bachelor of Dental Medicine contact
About this study
Official title: Radiographic and Histomorphometric Assessment for Alveolar Ridge Preservation Using Autogenous Tooth Graft From Extracted Tooth Combined With Simvastatin 1:1 Versus Autogenous Tooth Graft: A Randomized Clinical Trial (RCT)
This study will be held to overcome the previous limitations related to bone loss after teeth extraction by taking advantages from both Autogenous tooth graft and Simvastatin which will offer a promising synergistic approach for reducing alveolar ridge resorption, enhance bone regeneration and ensuring implant site development for future implant placement. This combination will address the gap in knowledge and offering a novel approach in alveolar ridge preservation. The Autogenous tooth graft will provide a scaffold and growth factor source for bone regeneration while Simvastatin will promotes osteogensis and angiogensis at graft site. So The goal of the present trial aims to evaluate the first-time application of Autogenous tooth graft from extracted tooth combined with Simvastatin with a ratio 1:1(test group) versus Autogenous tooth graft alone (control group) at an extraction socket of non molar single rooted teeth for alveolar ridge preservation and implant site development prior to implant placement.
The participants will be divided into two groups:
Intervention Group will receive Autogenous tooth graft combine with Simvastatin with a ratio 1:1 Control Group will receive Autogenous tooth graft. with follow up period 4 months.
Read the detailed description
Alveolar ridge resorption following tooth extraction is one of the greatest challenges in dentistry, especially for patients seeking dental implants. The alveolar ridge undergoes significant decrease in bone dimensions which will complicate the implant placement and thus necessitate additional grafting procedures to compensate the bone loss. Bone height decreases progressively by 25% during the first year after tooth loss, with a total of 4 mm of height lost during this first year post-extraction.
So various grafting materials such as Autogenous bone grafts, bone substitutes and allografts, are adopted to overcome this challenge and preserve the alveolar ridge. Autogenous grafts are always the gold standard and the benchmark of all graft types because of Its osteoinductive, osteoconductive, and osteogenic. However, secondary surgical sites, pain, high rates of donor site morbidity, and limited supply of graft material are the main disadvantages of autogenous graft.
Among these also, Autogenous tooth graft the promising solution due to its biocompatibility, osteogenic properties and nature compositions that mimics the structure and function of lost bone.
Autogenous tooth graft a type of autogenous grafting technique that utilizes the extracted tooth/teeth of the same individual for the preparation of the graft material. A relatively new and innovative bone graft material with all the advantages of autogenous bone owing to its very similar components to bone and can be very useful in a multitude of clinical situations.
- Conditions
- Alveolar Ridge Preservation, Horizontal Alveolar Bone Loss, Vertical Alveolar Bone Loss, Delayed Implant, Autogenous Tooth Graft
- Being tested
- Alveolar ridge preservation
- Keywords
- autogenous tooth graft, simvastatin, delayed implant, alveolar ridge preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge preservationProcedure or surgery
Grafting of the socket with Autogenous tooth graft mixed with simvastatin immediately after tooth extraction
Alveolar ridge preservationProcedure or surgery
Grafting the socket with Autogenous tooth graft immediately after tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| autogenous tooth graft combined with simvastatin 1:1 | Experimental | Test group : autogenous tooth graft from the extracted tooth combined with simvastatin drug with a ratio 1:1 Receives: Procedure: Alveolar ridge preservation |
| Autogenous tooth graft | Active comparator | Control group : Autogenous tooth graft Receives: Procedure: Alveolar ridge preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal bone width
Pre- and Post-ARP CBCT Scans immediately and 4 months after grafting The scans will be compared using predetermined reference points to assess the bone width changes.
Measured: 4 months after grafting
Secondary outcomes (2)
vertical bone height
Pre- and Post-ARP CBCT Scans will be taken immediately and after 4 months of grafting.
The scans will be compared using predetermined reference points to assess bone height changes.
Measured: 4 months after grafting
percentage of newly formed bone
histomorphometrical analysis of the percentage of newly formed bone through decalcified bone sections with H\&E stain using image analyzer computer Software.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start10 Jun 2025 (estimated)
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alveolar Ridge PreservationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- Randomized clinical trial (RCT) with parallel group ,two arms, with 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Mohamed Abd Elwhab, Cairo University
- Investigators
- Nadia Galal professor, phd holder, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879171
- Sponsor's protocol ID
- Alveolar Ridge Preservation AT
- Acronym
- ARP
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 20 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Janjua OS, Qureshi SM, Shaikh MS, Alnazzawi A, Rodriguez-Lozano FJ, Pecci-Lloret MP, Zafar MS. Autogenous Tooth Bone Grafts for Repair and Regeneration of Maxillofacial Defects: A Narrative Review. Int J Environ Res Public Health. 2022 Mar 20;19(6):3690. doi: 10.3390/ijerph19063690.
PubMed 35329377Beca-Campoy T, Sanchez-Labrador L, Blanco-Antona LA, Cortes-Breton Brinkmann J, Martinez-Gonzalez JM. Alveolar ridge preservation with autogenous tooth graft: A histomorphometric analysis of 36 consecutive procedures. Ann Anat. 2025 Feb;258:152375. doi: 10.1016/j.aanat.2025.152375. Epub 2025 Jan 6.
PubMed 39778754Zhang S, Li X, Qi Y, Ma X, Qiao S, Cai H, Zhao BC, Jiang HB, Lee ES. Comparison of Autogenous Tooth Materials and Other Bone Grafts. Tissue Eng Regen Med. 2021 Jun;18(3):327-341. doi: 10.1007/s13770-021-00333-4. Epub 2021 Apr 30.
PubMed 33929713
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic and Histomorphometric Assessment for Alveolar Ridge Preservation Using Autogenous Tooth Graft From Extracted Tooth Combined With Simvastatin 1:1 Versus Autogenous Tooth Graft: A Randomized Clinical Trial (RCT)
- ClinicalTrials.gov ID
- NCT06879171
- Acronym / sponsor ID
- ARP / Alveolar Ridge Preservation AT
- Conditions
- Alveolar Ridge Preservation, Horizontal Alveolar Bone Loss, Vertical Alveolar Bone Loss, Delayed Implant, Autogenous Tooth Graft
- Keywords
- autogenous tooth graft, simvastatin, delayed implant, alveolar ridge preservation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (estimated)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 17 Mar 2025 (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 will be held to overcome the previous limitations related to bone loss after teeth extraction by taking advantages from both Autogenous tooth graft and Simvastatin which will offer a promising synergistic approach for reducing alveolar ridge resorption, enhance bone regeneration and ensuring implant site development for future implant placement. This combination will address the gap in knowledge and offering a novel approach in alveolar ridge preservation. The Autogenous tooth graft will provide a scaffold and growth factor source for bone regeneration while Simvastatin will promotes osteogensis and angiogensis at graft site. So The goal of the present trial aims to evaluate the first-time application of Autogenous tooth graft from extracted tooth combined with Simvastatin with a ratio 1:1(test group) versus Autogenous tooth graft alone (control group) at an extraction socket of non molar single rooted teeth for alveolar ridge preservation and implant site development prior to implant placement.
The participants will be divided into two groups:
Intervention Group will receive Autogenous tooth graft combine with Simvastatin with a ratio 1:1 Control Group will receive Autogenous tooth graft. with follow up period 4 months.
Detailed description
Alveolar ridge resorption following tooth extraction is one of the greatest challenges in dentistry, especially for patients seeking dental implants. The alveolar ridge undergoes significant decrease in bone dimensions which will complicate the implant placement and thus necessitate additional grafting procedures to compensate the bone loss. Bone height decreases progressively by 25% during the first year after tooth loss, with a total of 4 mm of height lost during this first year post-extraction.
So various grafting materials such as Autogenous bone grafts, bone substitutes and allografts, are adopted to overcome this challenge and preserve the alveolar ridge. Autogenous grafts are always the gold standard and the benchmark of all graft types because of Its osteoinductive, osteoconductive, and osteogenic. However, secondary surgical sites, pain, high rates of donor site morbidity, and limited supply of graft material are the main disadvantages of autogenous graft.
Among these also, Autogenous tooth graft the promising solution due to its biocompatibility, osteogenic properties and nature compositions that mimics the structure and function of lost bone.
Autogenous tooth graft a type of autogenous grafting technique that utilizes the extracted tooth/teeth of the same individual for the preparation of the graft material. A relatively new and innovative bone graft material with all the advantages of autogenous bone owing to its very similar components to bone and can be very useful in a multitude of clinical situations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial (RCT) with parallel group ,two arms, with 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| autogenous tooth graft combined with simvastatin 1:1 | Experimental | Procedure: Alveolar ridge preservationTest group : autogenous tooth graft from the extracted tooth combined with simvastatin drug with a ratio 1:1 |
| Autogenous tooth graft | Active comparator | Procedure: Alveolar ridge preservationControl group : Autogenous tooth graft |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with badly broken, non-restorable, or periodontally hopeless non molar single rooted teeth.
- Age from 20-45 years old(6,13). No sex predilection.
- Medically free from any medical condition that would interfere with bone healing.
- Patients with status classification (ASA I \& II) with adequate oral hygiene condition.
- Alveolar sockets free from any preexisting periapical pathology based on intraoral periapical or panoramic radiograph.
Key exclusion criteria (6 listed)
- Patients with any medical condition that contraindicated the procedure and general contraindications for Implant Surgery(6,13)
- Patients who are allergic to Simvastatin drug.(6)
- Presence of active infection around the tooth or remaining root.
- Psychological reasons that might affect the procedure or the subsequent follow up visits.
- 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 |
|---|---|---|
| Alveolar ridge preservationGrafting of the socket with Autogenous tooth graft mixed with simvastatin immediately after tooth extraction | Procedure or surgery | autogenous tooth graft combined with simvastatin 1:1 |
| Alveolar ridge preservationGrafting the socket with Autogenous tooth graft immediately after tooth extraction | Procedure or surgery | Autogenous tooth graft |
Primary outcome
Horizontal bone width
Time frame: 4 months after grafting
Pre- and Post-ARP CBCT Scans immediately and 4 months after grafting The scans will be compared using predetermined reference points to assess the bone width changes.
2 secondary outcomes
vertical bone height
Time frame: 4 months after grafting
percentage of newly formed bone
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Background: PubMed 35329377Janjua OS, Qureshi SM, Shaikh MS, Alnazzawi A, Rodriguez-Lozano FJ, Pecci-Lloret MP, Zafar MS. Autogenous Tooth Bone Grafts for Repair and Regeneration of Maxillofacial Defects: A Narrative Review. Int J Environ Res Public Health. 2022 Mar 20;19(6):3690. doi: 10.3390/ijerph19063690.
- Background: PubMed 39778754Beca-Campoy T, Sanchez-Labrador L, Blanco-Antona LA, Cortes-Breton Brinkmann J, Martinez-Gonzalez JM. Alveolar ridge preservation with autogenous tooth graft: A histomorphometric analysis of 36 consecutive procedures. Ann Anat. 2025 Feb;258:152375. doi: 10.1016/j.aanat.2025.152375. Epub 2025 Jan 6.
- Results publication: PubMed 33929713Zhang S, Li X, Qi Y, Ma X, Qiao S, Cai H, Zhao BC, Jiang HB, Lee ES. Comparison of Autogenous Tooth Materials and Other Bone Grafts. Tissue Eng Regen Med. 2021 Jun;18(3):327-341. doi: 10.1007/s13770-021-00333-4. Epub 2021 Apr 30.
- https://pmc.ncbi.nlm.nih.gov/articles/PMC5822533/Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Effect of Collagen Membrane on Ridge Preservation
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Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
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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.
Nourhan Mohamed Abd Elwahab, Bachelor of Dental Medicine contact
Nadia Galal professor, phd holder principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar ridge preservation in people with Alveolar Ridge Preservation and Horizontal Alveolar Bone Loss, run by Cairo 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 5 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: opening soon, as of the sponsor's last update on 20 May 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Mohamed Abd Elwahab, Bachelor of Dental Medicine (01094463159, nourhan.abdelwhab@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal bone width (time frame: 4 months after grafting). 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 NCT06879171, which also lists 3 linked publications.
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 20 May 2025.