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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-45
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alveolar ridge preservation

    Procedure/Surgery

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

  • Alveolar ridge preservation

    Procedure/Surgery

    Grafting the socket with Autogenous tooth graft immediately after tooth extraction

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: autogenous tooth graft combined with simvastatin 1:1Experimental treatment 1 intervention
Group B: Autogenous tooth graftActive comparator 1 intervention

Trial outcomes

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.

Time frame
4 months after grafting

Secondary outcomes

1

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.

Time frame
4 months after grafting
2

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.

Time frame
4 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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