NCT07267637

Brief Summary

The purpose of this clinical experiment is to assess how well autogenous tooth bone grafting preserves the alveolar socket after surgical tooth extraction. Before being inserted into the socket, the graft is made from the patient's own extracted tooth and ground into a particle. Twenty Yemeni patients who needed their teeth extracted are included in the trial, and they will be followed up with clinical and radiographic procedures using cone-beam computed tomography (CBCT) for six months. The primary objective is to ascertain whether the autogenous dental bone graft can preserve the height, width, and density of alveolar bone, offering a secure, affordable, and biocompatible substitute for traditional grafting materials.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jul 2024Aug 2026

Study Start

First participant enrolled

July 14, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

November 23, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

Autogenous Tooth Bone GraftSocket PreservationCBCT ImagingBone Density MeasurementBone Regeneration in Dentistry

Outcome Measures

Primary Outcomes (1)

  • "Alveolar Bone Height, Width, and Density Preservation with Autogenous Tooth Bone Graft"

    This study aims to evaluate the effectiveness of autogenous tooth bone grafts in preserving alveolar bone following tooth extraction. The study will assess changes in alveolar bone height, width, and density using Cone Beam Computed Tomography (CBCT) at two time points: before extraction (baseline) and 6 months post-grafting. The outcome measures are: Alveolar Bone Height: Measured in millimeters using CBCT at baseline and 6 months. Alveolar Bone Width: Measured in millimeters using CBCT at baseline and 6 months. Alveolar Bone Density: Measured in Hounsfield units using CBCT at both time points. The intervention involves using the patient's own extracted tooth to create a bone graft placed into the socket, promoting healing and bone regeneration. This study will determine the effectiveness of autogenous tooth bone grafts in preventing bone resorption and preserving alveolar socket structure.

    "Before extraction and 6 months post-intervention"

Study Arms (1)

Autogenous Tooth Bone Graft Intervention Group

EXPERIMENTAL

"In this arm of the study, participants will receive an autogenous tooth bone graft for alveolar socket preservation following surgical tooth extraction. The intervention involves the extraction of the patient's own tooth, which will be processed and used as a bone graft. This graft will be placed into the empty socket immediately after the extraction. The purpose of this intervention is to prevent bone resorption, promote natural healing, and support bone regeneration within the extraction site. CBCT scans will be performed before extraction to measure baseline bone dimensions and will be repeated 6 months post-intervention to assess the success of bone preservation in terms of height, width, and density."

Biological: "Autogenous Tooth Bone Graft"

Interventions

"The intervention involves the use of the patient's own extracted tooth to create a bone graft for alveolar socket preservation following surgical tooth extraction. The patient's tooth is carefully processed to remove caries, periodontal ligaments, pulp, and any restorative materials, leaving behind a complete tooth structure (enamel, dentin, and cementum). This tooth is then crushed, disinfected, and treated before being placed into the empty socket. This graft helps maintain the structure of the alveolar bone by promoting natural bone regeneration and preventing resorption. The bone graft will be monitored for its efficacy in preserving alveolar bone height, width, and density, assessed using Cone Beam Computed Tomography (CBCT)."

Autogenous Tooth Bone Graft Intervention Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Absence of systemic diseases.
  • Very good to accepted oral hygiene.
  • Patients with impacted teeth requiring extraction.
  • Patients between the ages of 16 and 50.
  • No history of smoking.
  • No history of any other drug use.
  • Patients who were cooperative, motivated, to attend the follow-up and maintenance visits.

You may not qualify if:

  • Systemic conditions or pharmacological therapies that could be an absolute contraindication for the intervention (such as un controlled diabetics, immunocompromised states, or treatment with oral or parenteral bisphosphonates).
  • Poor oral hygiene.
  • Acute exacerbation of chronic infection like pain or swelling.
  • Pregnant women, children, elderly (\>60 years), physically and mentally challenged, terminally and seriously ill.
  • Hight Smoking tendency.
  • Patients who refused to participate in the trial.
  • Uncooperative Patients who won't be able to maintain the follow up visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sana'a University faculty of Dentisrty

Sanaa, Sanaa Governorate, Yemen

Location

Related Publications (2)

  • Valdec S, Pasic P, Soltermann A, Thoma D, Stadlinger B, Rucker M. Alveolar ridge preservation with autologous particulated dentin-a case series. Int J Implant Dent. 2017 Dec;3(1):12. doi: 10.1186/s40729-017-0071-9. Epub 2017 Mar 30.

  • Mahardawi B, Damrongsirirat N, Dhanesuan K, Subbalekha K, Mattheos N, Pimkhaokham A. Radiographic changes after alveolar ridge preservation using autogenous raw tooth particles versus xenograft: A prospective controlled clinical trial. Clin Oral Implants Res. 2024 Dec;35(12):1597-1606. doi: 10.1111/clr.14348. Epub 2024 Aug 12.

Related Links

Study Officials

  • Haifaa Alhussini, BDS, MSc

    Sana'a University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a single-arm, open-label clinical trial designed to evaluate the efficacy of autogenous tooth bone grafts for alveolar socket preservation following sugrical tooth extraction. The intervention involves the use of the patient's own extracted tooth to prepare the bone graft, which will be placed into the extraction socket. The primary objective is to assess changes in alveolar bone height, width, and density before extraction and after six months of intervention using Cone Beam Computed Tomography (CBCT). All participants will undergo the same procedure, and no control group will be included. The study aims to explore the feasibility and outcomes of using autogenous grafts in dental socket preservation procedures
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
"Principal Investigator, Haifaa Al-Hussini, BDS, MSc Candidate, Sana'a University"

Study Record Dates

First Submitted

November 23, 2025

First Posted

December 5, 2025

Study Start

July 14, 2024

Primary Completion

November 1, 2025

Study Completion (Estimated)

August 31, 2026

Last Updated

December 5, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

"We will share anonymized individual participant data (IPD), including baseline characteristics, clinical assessments, and key outcome measures (alveolar bone height, width, and density) collected before and after the autogenous tooth bone graft intervention. Access to the data will be granted to qualified researchers who meet the criteria for data sharing and comply with the applicable data use agreement."

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
"IPD and supporting information will be made available starting 12 months after the completion of the study. The data will be accessible for a period of 5 years."
Access Criteria
"Access to IPD and supporting information will be granted to qualified researchers who submit a data request via the ClinicalTrials.gov platform. Researchers must meet the criteria outlined in the Data Use Agreement, which ensures that the data will be used responsibly and for research purposes only."
More information

Available IPD Datasets

Clinical Study Report (https://doi.org/10.1111/clr.14)Access
Clinical Study Report (https://doi.org/10.1186/s40729)Access

Locations