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Radiographic and Histomorphometric Assessment for Alveolar Ridge Preservation Using Autogenous Tooth Graft From Extracted Tooth Combined With Simvastatin 1:1 Versus Autogenous Tooth Graft

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)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06879171
Acronym
ARP
Enrollment
26
Registered
2025-03-17
Start date
2025-06-10
Completion date
2026-06-10
Last updated
2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Ridge Preservation, Autogenous Tooth Graft, Delayed Implant, Horizontal Alveolar Bone Loss, Vertical Alveolar Bone Loss

Keywords

autogenous tooth graft, simvastatin, delayed implant, alveolar ridge preservation

Brief 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 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.

Interventions

PROCEDUREAlveolar ridge preservation

Grafting of the socket with Autogenous tooth graft mixed with simvastatin immediately after tooth extraction

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Study participants will be blinded and each patient will be given a code by the researcher (N.M). Blinding of the investigator (N.M) isn't applicable. Biostatistician will be blinded. Participants' identity and their corresponding study group will be concealed by assigning an identification number to all laboratory specimens, data files and reports for the transfer data to and from assessors.

Intervention model description

Randomized clinical trial (RCT) with parallel group ,two arms, with 1:1 allocation ratio.

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Horizontal bone width4 months after graftingPre- 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.

Secondary

MeasureTime frameDescription
vertical bone height4 months after graftingPre- 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.
percentage of newly formed bone4 monthshistomorphometrical analysis of the percentage of newly formed bone through decalcified bone sections with H&E stain using image analyzer computer Software.

Contacts

Primary ContactNourhan Mohamed Abd Elwahab, Bachelor of Dental Medicine
nourhan.abdelwhab@dentistry.cu.edu.eg01094463159

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026