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

May 19, 2025 updated by: Nourhan Mohamed Abd Elwhab, Cairo University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: autogenous tooth graft combined with simvastatin 1:1
Test group : autogenous tooth graft from the extracted tooth combined with simvastatin drug with a ratio 1:1
Procedure: Alveolar ridge preservation
Grafting of the socket with Autogenous tooth graft mixed with simvastatin immediately after tooth extraction
Procedure: Alveolar ridge preservation
Grafting the socket with Autogenous tooth graft immediately after tooth extraction
Active Comparator: Autogenous tooth graft
Control group : Autogenous tooth graft
Procedure: Alveolar ridge preservation
Grafting of the socket with Autogenous tooth graft mixed with simvastatin immediately after tooth extraction
Procedure: Alveolar ridge preservation
Grafting the socket with Autogenous tooth graft immediately after tooth extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months after grafting

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vertical bone height
Time Frame: 4 months after grafting

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.
4 months after grafting
percentage of newly formed bone
Time Frame: 4 months
histomorphometrical analysis of the percentage of newly formed bone through decalcified bone sections with H&E stain using image analyzer computer Software.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Nadia Galal professor, phd holder, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 10, 2025

Primary Completion (Estimated)

December 10, 2025

Study Completion (Estimated)

June 10, 2026

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 17, 2025

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alveolar Ridge Preservation AT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alveolar Ridge Preservation

Clinical Trials on Alveolar ridge preservation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe