Alveolar Bone LossNCT06457373
Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation
A study testing Demineralized Dentin Allograft and Demineralized Dentin Autograft in people with Alveolar Bone Loss, run by Horus University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Demineralized Dentin Allograft and Demineralized Dentin Autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Aug 2026to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged between 25 to 35 years old.
- Patients scored as (ASA I).
- No adverse habits such as smoking, tobacco chewing, alcohol.
- Patients having bilaterally impacted mandibular third molar with similar degree of difficulty according to (Kim JY, et al).
- The recipient alveolar sockets are free of any pre-existing periapical pathology, based on x-ray.
- Alveolar sockets with a depth of 5 mm or more, using periodontal probe for assessment.
- Patients sign a consent for all procedures.
Who cannot join
- 1) Pregnant or lactating patients. 2) Relevant systemic diseases. 3) Patients with history of chemotherapy or radiotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry- Horus University in Egypt
Damietta, New-Damietta, 34518
Mohamed Habib, B.D.S, +2001069505336, mbasiouny@horus.edu.eg
About this study
Official title: 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.
- Conditions
- Alveolar Bone Loss
- Being tested
- Demineralized Dentin Allograft, Demineralized Dentin Autograft
- Keywords
- Socket preservation, Impacted mandibular third molar, Alveolar ridge Augmentation
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demineralized Dentin AllograftProcedure or surgery
Also called DDA
20 sockets are randomly allocated to receive the Demineralized Dentin Allograft (split-mouth study)
Demineralized Dentin AutograftProcedure or surgery
Also called Auto-DD
20 sockets are randomly allocated to receive the Demineralized Dentin Autograft (split-mouth study)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 20 sockets will be grafted with Demineralized Dentin Allograft (DDA) Receives: Procedure: Demineralized Dentin Allograft |
| Group B | Active comparator | 20 sockets will be grafted with Demineralized Dentin Autograft (Auto-DD) Receives: Procedure: Demineralized Dentin Autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring and comparing the height of bone between the two groups
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
Measured: Immediately post-operative, 3months post-operative, 6months post-operative
Measuring and comparing the width of bone between the two groups
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
Measured: Immediately post-operative, 3months post-operative, 6months post-operative
Secondary outcomes (4)
Assess and comparing the mouth opening of both groups
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
Measured: One day post-operative, one week post-operative
Assess and comparing the swelling of both groups
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.
Measured: One day post-operative, one week post-operative
Assess and comparing the pain of both groups
we will use the Visual Analogue Scale (VAS) for pain measurement
Measured: 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
The bleeding on probing will be assessed by using periodontal probe and this will be done around mandibular first and second molars
Measured: One day post-operative, one week post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start13 Aug 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 20 sockets will be grafted with Demineralized Dentin Allograft (DDA) and 20 sockets will be grafted with Demineralized Dentin Autograft (Auto-DD)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ali Habib, Horus University
- Investigators
- Mohamed Habib, B.D.S, Principal investigator, Faculty of Dentistry- Horus University in EgyptAhmed Khalil, Study director, Faculty of Dentistry- Horus University in EgyptEman Abdelsalam, Study director, Faculty of Dentistry- Horus University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457373
- Sponsor's protocol ID
- (DDA) for socket preservation
- Status last verified
- Aug 2026
- First submitted
- 3 Jun 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joshi CP, D'Lima CB, Samat UC, Karde PA, Patil AG, Dani NH. Comparative Alveolar Ridge Preservation Using Allogenous Tooth Graft versus Free-dried Bone Allograft: A Randomized, Controlled, Prospective, Clinical Pilot Study. Contemp Clin Dent. 2017 Apr-Jun;8(2):211-217. doi: 10.4103/ccd.ccd_147_17.
PubMed 28839405Grover V, Kapoor A, Malhotra R, Sachdeva S. Bone allografts: a review of safety and efficacy. Indian J Dent Res. 2011 May-Jun;22(3):496. doi: 10.4103/0970-9290.87084.
PubMed 22048602
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation After Surgical Extraction of Impacted Mandibular Third Molar
- ClinicalTrials.gov ID
- NCT06457373
- Acronym / sponsor ID
- (DDA) for socket preservation
- Conditions
- Alveolar Bone Loss
- Keywords
- Socket preservation, Impacted mandibular third molar, Alveolar ridge Augmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 20 sockets will be grafted with Demineralized Dentin Allograft (DDA) and 20 sockets will be grafted with Demineralized Dentin Autograft (Auto-DD)
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Demineralized Dentin Allograft20 sockets will be grafted with Demineralized Dentin Allograft (DDA) |
| Group B | Active comparator | Procedure: Demineralized Dentin Autograft20 sockets will be grafted with Demineralized Dentin Autograft (Auto-DD) |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients aged between 25 to 35 years old.
- Patients scored as (ASA I).
- No adverse habits such as smoking, tobacco chewing, alcohol.
- Patients having bilaterally impacted mandibular third molar with similar degree of difficulty according to (Kim JY, et al).
- The recipient alveolar sockets are free of any pre-existing periapical pathology, based on x-ray.
Key exclusion criteria (1 listed)
- 1) Pregnant or lactating patients. 2) Relevant systemic diseases. 3) Patients with history of chemotherapy or radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Demineralized Dentin AllograftAlso: DDA20 sockets are randomly allocated to receive the Demineralized Dentin Allograft (split-mouth study) | Procedure or surgery | Group A |
| Demineralized Dentin AutograftAlso: Auto-DD20 sockets are randomly allocated to receive the Demineralized Dentin Autograft (split-mouth study) | Procedure or surgery | Group B |
Primary outcome
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
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
4 secondary outcomes
Assess and comparing the mouth opening of both groups
Time frame: 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
Assess and comparing the pain of both groups
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 28839405Joshi CP, D'Lima CB, Samat UC, Karde PA, Patil AG, Dani NH. Comparative Alveolar Ridge Preservation Using Allogenous Tooth Graft versus Free-dried Bone Allograft: A Randomized, Controlled, Prospective, Clinical Pilot Study. Contemp Clin Dent. 2017 Apr-Jun;8(2):211-217. doi: 10.4103/ccd.ccd_147_17.
- Background: PubMed 22048602Grover V, Kapoor A, Malhotra R, Sachdeva S. Bone allografts: a review of safety and efficacy. Indian J Dent Res. 2011 May-Jun;22(3):496. doi: 10.4103/0970-9290.87084.
- Individual participant dataSharing planned: No
Related trials for Alveolar Bone Loss
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Habib, B.D.S principal investigator
Faculty of Dentistry- Horus University in Egypt
Ahmed Khalil study director
Faculty of Dentistry- Horus University in Egypt
Eman Abdelsalam study director
Faculty of Dentistry- Horus University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Demineralized Dentin Allograft and Demineralized Dentin Autograft in people with Alveolar Bone Loss, run by Horus University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Habib, B.D.S (+2001069505336, mbasiouny@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring and comparing the height of bone between the two groups (time frame: Immediately post-operative, 3months post-operative, 6months post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06457373, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.