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

NCT06879171 | Not Yet Recruiting

• 1 other identifier: Alveolar Ridge Preservation AT
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months after grafting

Secondary Outcomes (2)

• vertical bone height

  4 months after grafting

• percentage of newly formed bone

  4 months

Study Arms (2)

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

Procedure: Alveolar ridge preservation

Autogenous tooth graft

ACTIVE COMPARATOR

Control group : Autogenous tooth graft

Procedure: Alveolar ridge preservation

Interventions

Alveolar ridge preservation PROCEDURE

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

autogenous tooth graft combined with simvastatin 1:1

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Related Publications (3)

• 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.

  PMID: 35329377 BACKGROUND

• Beca-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.

  PMID: 39778754 BACKGROUND

• Zhang 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.

  PMID: 33929713 BACKGROUND

Related Links

• https://pmc.ncbi.nlm.nih.gov/articles/PMC5822533/

Study Officials

• Nadia Galal professor, phd holder

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nourhan Mohamed Abd Elwahab, Bachelor of Dental Medicine

CONTACT

01094463159; nourhan.abdelwhab@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dentist

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

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: June 10, 2025
• Primary Completion: December 10, 2025
• Study Completion (Estimated): June 10, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-03