Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation

August 14, 2026 updated by: Mohamed Ali Habib, Horus University

The Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation After Surgical Extraction of Impacted Mandibular Third Molar

This study is designed to evaluate and compare clinically and radiographically the effectiveness of Demineralized Dentin Allograft (DDA) versus Demineralized Dentin Autograft (Auto-DD) for preservation of alveolar ridge dimensions after surgical extraction of the impacted mandibular third molar.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • New-Damietta
      • Damietta, New-Damietta, Egypt, 34518
        • Recruiting
        • Faculty of Dentistry- Horus University in Egypt
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients aged between 25 to 35 years old.
  2. Patients scored as (ASA I).
  3. No adverse habits such as smoking, tobacco chewing, alcohol.
  4. Patients having bilaterally impacted mandibular third molar with similar degree of difficulty according to (Kim JY, et al).
  5. The recipient alveolar sockets are free of any pre-existing periapical pathology, based on x-ray.
  6. Alveolar sockets with a depth of 5 mm or more, using periodontal probe for assessment.
  7. Patients sign a consent for all procedures.

Exclusion Criteria:

  • 1) Pregnant or lactating patients. 2) Relevant systemic diseases. 3) Patients with history of chemotherapy or radiotherapy.

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
20 sockets will be grafted with Demineralized Dentin Allograft (DDA)
Procedure: Demineralized Dentin Allograft
20 sockets are randomly allocated to receive the Demineralized Dentin Allograft (split-mouth study)
Other Names:
  • DDA
Active Comparator: Group B
20 sockets will be grafted with Demineralized Dentin Autograft (Auto-DD)
Procedure: Demineralized Dentin Autograft
20 sockets are randomly allocated to receive the Demineralized Dentin Autograft (split-mouth study)
Other Names:
  • Auto-DD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measuring and comparing the height of bone between the two groups
Time Frame: Immediately post-operative, 3months post-operative, 6months post-operative
We will measure the height of the alveolar ridge clinically by using ridge mapping caliper (special caliper forceps used for measuring ridge dimensions) and radiographically on the cone-beam computed tomography (CBCT) and comparing the results of the study group (20 sockets) with the control group (the other 20sockets), to assess the effectiveness of Demineralized Dentin Allograft for ridge preservation
Immediately post-operative, 3months post-operative, 6months post-operative
Measuring and comparing the width of bone between the two groups
Time Frame: Immediately post-operative, 3months post-operative, 6months post-operative
We will measure the width of the alveolar ridge clinically by using ridge mapping caliper (special caliper forceps used for measuring ridge dimensions) and radiographically on the cone-beam computed tomography (CBCT) and comparing the results of the study group (20 sockets) with the control group (the other 20sockets), to assess the effectiveness of Demineralized Dentin Allograft for ridge preservation
Immediately post-operative, 3months post-operative, 6months post-operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess and comparing the mouth opening of both groups
Time Frame: One day post-operative, one week post-operative
Assess the mouth opening of the patient using a millimeter ruler (by measuring the distance between maxillary incisal edge and mandibular incisal edge) and comparing the results of both groups
One day post-operative, one week post-operative
Assess and comparing the swelling of both groups
Time Frame: One day post-operative, one week post-operative

Swelling levels after surgery will be measured using anatomic landmarks (Tragus-Labial commissure and Tragus-Pogonion), the distances between the landmarks used for the evaluation methods will be measured before the operation.

All measurements will be done using millimeter ruler, while the patient will be seated.
One day post-operative, one week post-operative
Assess and comparing the pain of both groups
Time Frame: One day post-operative, one week post-operative
we will use the Visual Analogue Scale (VAS) for pain measurement
One day post-operative, one week post-operative
Assess and comparing the soft tissue parameters (bleeding on probing and color of the gingiva) of both groups
Time Frame: One day post-operative, one week post-operative
The bleeding on probing will be assessed by using periodontal probe and this will be done around mandibular first and second molars
One day post-operative, one week post-operative

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Horus University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed Habib, B.D.S, Faculty of Dentistry- Horus University in Egypt
  • Study Director: Ahmed Khalil, Faculty of Dentistry- Horus University in Egypt
  • Study Director: Eman Abdelsalam, Faculty of Dentistry- Horus University in Egypt

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

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • (DDA) for socket preservation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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