Alveolar Ridge PreservationDDG-ARPNCT07242313
Comparison of Demineralized and Mineralized Dentin Grafts in Ridge Preservation
A study testing Demineralized Allogeneic Dentin Graft and Mineralized Allogeneic Dentin Graft in people with Alveolar Ridge Preservation and Post Extraction Alveolar Bone Resorption, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This clinical investigation aims to assess how two different allogeneic dentin graft materials - one de-mineralized and the other mineralized - influence bone preservation following extraction of a single upper posterior tooth. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alveolar Ridge Preservation, Post Extraction Alveolar Bone Resorption
- What is being tested?
- Demineralized Allogeneic Dentin Graft and Mineralized Allogeneic Dentin Graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Oct 2025to 31 Aug 2026
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 60 years.
- Medically healthy patients classified as ASA I.
- Presence of a single non-restorable tooth indicated for extraction in the posterior maxilla.
- Adequate oral hygiene, with plaque and bleeding indices both below 20%.
- Sufficient bone volume to allow socket preservation without requiring simultaneous augmentation.
- Patients willing to participate in the study and able to provide written informed consent.
- Ability to commit to follow-up visits for up to 6 months.
Who cannot join
- Smokers or tobacco users of any form.
- Presence of uncontrolled systemic diseases (e.g., uncontrolled diabetes).
- Conditions affecting bone metabolism (e.g., osteoporosis, long-term corticosteroid therapy).
- Pregnant or lactating women.
- History of radiotherapy in the head and neck region.
- Active infection or suppuration at the extraction site.
Show all 9Show fewer
- Immunocompromised patients or those on immunosuppressive therapy.
- Patients taking medications known to impair healing (e.g., bisphosphonates).
- Allergy or hypersensitivity to any study-related materials.
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, Kafrelsheikh University
Kafr ash Shaykh
Ahmed Abdelaziz, BDS, MSc candidate, +201157315278, ahmed.mousa@den.kfs.edu.eg
About this study
Official title: Comparative Study Between Demineralized and Mineralized Allogeneic Dentin Grafts for Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
This clinical investigation aims to assess how two different allogeneic dentin graft materials - one de-mineralized and the other mineralized - influence bone preservation following extraction of a single upper posterior tooth. A total of 45 patients will be randomly allocated into three equal groups: a socket-only spontaneous healing group (control), a de-mineralized dentin graft group, and a mineralized dentin graft group. Over a six-month period after extraction, measurements will be taken using CBCT to monitor changes in ridge width, height, and bone density. Secondary outcomes include patient-reported pain, postoperative swelling, satisfaction levels, width of keratinized tissue, and histomorphometric data from biopsy samples at implant placement. Findings from this trial may support evidence-based decisions in alveolar ridge preservation and help clinicians choose the most predictable grafting strategy before implant placement.
Read the detailed description
The alveolar ridge experiences rapid remodeling after tooth extraction, often resulting in significant bone loss if no graft is placed. Clinical observations indicate that an extraction site may lose roughly half of its original width within six to twelve months, severely reducing the bone available for future implants or prosthetic support. This resorption occurs because removal of the tooth and its periodontal ligament eliminates the normal mechanical stimulation that maintains the surrounding bone. Alveolar ridge preservation techniques aim to counteract this remodeling by placing a graft in the extraction socket to maintain bone dimensions and support healing. Preserving the ridge anatomy in this way is critical for subsequent restorative procedures such as dental implant placement or denture support.
In practice, a variety of graft materials have been used to support alveolar ridge preservation. Autogenous bone grafts (harvested from the patient's own body, for example from the iliac crest or intraoral sites) have osteogenic and osteoinductive properties, but require a second surgical site and provide limited graft volume. Alternative materials include allogeneic bone (processed human bone from donors) and xenogeneic bone (such as bovine-derived hydroxyapatite), which are readily available but may integrate more slowly and raise concerns about immune reaction or disease transmission. Synthetic or alloplastic graft materials (calcium phosphates, bioactive glasses, polymers, etc.) are also used, although they typically act only as osteoconductive scaffolds and may not match the biologic activity of natural tissues. Given these limitations, there is ongoing interest in novel graft sources that can offer both safety and biological efficacy.
One promising graft material is dentin, the calcified tissue comprising the bulk of a tooth beneath the enamel. Chemically, dentin closely resembles bone: it is roughly 70% mineral (hydroxyapatite) and 20% organic matrix (predominantly type I collagen) by weight, along with non-collagenous proteins and embedded growth factors. Because dentin is acellular and avascular, it is inherently well-tolerated when used as a graft. Importantly, its organic matrix contains signaling molecules such as bone morphogenetic proteins (BMPs) and other growth factors that are naturally osteoinductive. In clinical practice, an extracted tooth can be cleaned and converted into graft material by grinding it into particulate form or shaping it into a block. Clinical studies have shown that autogenous tooth-derived grafts (using a patient's own extracted tooth) can effectively support socket preservation and guided bone regeneration. However, this approach is limited by the availability of teeth in each patient and by variability in processing methods, which can affect the consistency of the graft material.
Dentin grafts can be prepared in different forms. Demineralized dentin matrix (DDM) is produced by treating the dentin with acid to remove most of the mineral phase, leaving a collagen-rich matrix that retains the dentin's organic proteins and growth factors. DDM is highly osteoinductive: by removing the crystalline mineral, the embedded signaling molecules (such as BMPs and transforming growth factors) are exposed, creating a bioactive scaffold that strongly stimulates new bone formation. In contrast, a fully mineralized dentin graft (for example, ground whole tooth particles that are not demineralized) retains the hydroxyapatite content, which contributes rigidity and initial volume stability. These mineralized grafts act primarily as an osteoconductive scaffold and release bioactive molecules more slowly as they resorb. In practical terms, demineralized dentin grafts are believed to accelerate early bone ingrowth, whereas mineralized dentin grafts may better preserve the initial socket architecture and support gradual long-term remodeling.
Allogeneic dentin grafts are obtained from healthy human donor teeth that have been processed and sterilized under controlled conditions. The use of donated extracted teeth provides a scalable graft source and repurposes material that would otherwise be discarded. Processing typically involves cleaning away any attached soft tissues, removing enamel and cementum, and grinding the remaining tooth structure into particles. Sterilization (for example by freeze-drying, gamma irradiation, or other validated methods) ensures the graft is safe for implantation. For demineralized allografts, an additional acid step is applied to decalcify the particles. These preparation steps remove or inactivate cells and pathogens, minimizing immunogenic components. Preclinical studies suggest that properly processed allogeneic dentin matrix can induce bone formation with minimal immune reaction or rejection. However, standardized clinical evidence on allogeneic dentin grafts remains limited.
Given this background, the current trial is designed to determine which graft preparation yields better ridge preservation outcomes. Both demineralized and mineralized allogeneic dentin grafts are expected to support bone healing, but they may influence the process differently. Demineralized allogeneic dentin grafts, with their exposed collagen matrix and retained growth factors, may encourage rapid initial bone ingrowth. Mineralized allogeneic dentin grafts may offer greater immediate structural support and preserve socket volume over time, although they tend to release growth factors more slowly. The comparative performance of these two graft types in humans has not been established, creating a clear need for a controlled clinical study.
This randomized controlled clinical trial will enroll patients undergoing single-tooth extraction who require ridge preservation. Patients will be randomly assigned to receive either a demineralized allogeneic dentin graft or a mineralized allogeneic dentin graft placed into the fresh extraction socket. In each case the graft material will be placed immediately after extraction and the site will be closed using standard surgical technique. Both groups will follow the same postoperative care and follow-up protocol. After a predetermined healing interval (for example, three to six months), the sites will be re-entered for evaluation. Assessment will include clinical inspection and radiographic imaging of the ridge, and if feasible histological analysis of any newly formed bone, to compare bone volume and architecture between the two graft types.
This study addresses a gap in current clinical evidence, as no published trials have directly compared demineralized and mineralized human dentin grafts for socket preservation. Prior research has shown that autologous tooth-derived grafts can be effective for ridge preservation, but the optimal approach for donated (allogeneic) dentin remains uncertain. The findings of this trial will provide evidence-based guidance on graft material selection in extraction site management. If one graft type proves superior, this would validate the use of donated human teeth as a sustainable and effective bone graft source, potentially reducing reliance on animal-derived or synthetic substitutes. Ultimately, optimizing socket grafting methods is expected to enhance outcomes in implant and prosthetic dentistry by preserving bone anatomy and facilitating successful restorative treatments.
- Being tested
- Demineralized Allogeneic Dentin Graft, Mineralized Allogeneic Dentin Graft
- Keywords
- Alveolar Ridge Preservation, Socket Preservation, Post-Extraction Bone Loss, Dentin Graft, Allogeneic Dentin, Demineralized Dentin Matrix, Mineralized Dentin Graft, Bone Regeneration, Histomorphometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demineralized Allogeneic Dentin GraftBiological
Particulate demineralized allogeneic dentin processed from donor teeth using standardized laboratory protocols, including cleaning, defatting, demineralization, dehydration, freeze-drying, and sterilization. The graft is placed into the extraction socket following atraumatic extraction, covered with a resorbable collagen dressing, and the site is closed to promote alveolar ridge preservation.
Mineralized Allogeneic Dentin GraftBiological
Particulate mineralized allogeneic dentin derived from processed donor teeth. The dentin is cleaned, defatted, ultrasonically treated, dehydrated, freeze-dried, and sterilized while retaining its mineral phase. The graft is inserted into the extraction socket after atraumatic extraction and covered with a resorbable collagen material prior to closure to support ridge preservation.
| Study group | Role | What they receive |
|---|---|---|
| Demineralized Allogeneic Dentin Graft | Experimental | After atraumatic tooth extraction, the socket is filled with demineralized allogeneic dentin particulate graft. The material is processed and sterilized according to standardized laboratory protocols. A resorbable collagen dressing is placed over the graft, followed by site closure. This arm evaluates the regenerative effectiveness of demineralized dentin on ridge preservation. Receives: Biological: Demineralized Allogeneic Dentin Graft |
| Mineralized Allogeneic Dentin Graft | Experimental | Following atraumatic extraction, the socket is grafted with mineralized allogeneic dentin particulate material processed and sterilized under controlled conditions. A resorbable collagen dressing is applied prior to closure. This arm assesses the ridge preservation outcomes produced by the mineralized form of dentin graft. Receives: Biological: Mineralized Allogeneic Dentin Graft |
| Control: Spontaneous Healing (Empty Socket) | No intervention | Participants in this arm undergo atraumatic tooth extraction followed by natural socket healing without graft placement. The socket is allowed to heal spontaneously to serve as the control for evaluating dimensional bone changes relative to grafted groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alveolar Ridge Width (Buccolingual Dimension)
Measurement of the buccolingual width of the alveolar ridge using standardized Cone-Beam Computed Tomography (CBCT). Width is measured at predetermined reference points to assess dimensional bone changes following grafting.
Measured: Baseline (immediately after extraction) and 6 months post-operative
Change in Alveolar Ridge Height (Vertical Dimension)
Vertical height of the alveolar ridge measured radiographically on CBCT at standardized anatomical landmarks to quantify bone height changes over the healing period.
Measured: Baseline and 6 months post-operative
Bone Density at the Grafted Site
Bone density at the extraction site measured using CBCT expressed in Hounsfield Units (HU) to evaluate bone quality gained after grafting
Measured: 6 months post-operative
Secondary outcomes (5)
Postoperative Pain Levels (VAS Score)
Postoperative pain will be evaluated using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates severe pain. Participants will record pain levels at predefined postoperative intervals.
Measured: 24, 48, and 72 hours post-operative
Postoperative swelling
Facial swelling will be assessed through standardized digital facial photographs taken at each time point. Facial dimensions will be analyzed using image analysis software to quantify postoperative edema.
Measured: Baseline (preoperative), 24, 48, and 72 hours post-operative
Patient Satisfaction Score
Patient satisfaction will be recorded using a structured questionnaire that scores satisfaction on a scale from 0 to 4 (0 = very satisfied, 4 = very dissatisfied). Participants will complete the questionnaire at designated follow-up intervals.
Measured: 6 months post-operative
Width of Keratinized Tissue
Keratinized tissue width will be measured using a UNC-15 periodontal probe at the buccal aspect of the site. Measurements will be taken at baseline and during the final follow-up to assess changes associated with socket healing.
Measured: Baseline and 6 months post-operative
Histomorphometric Analysis of Bone Core Biopsies
Histological assessment of bone core biopsies harvested at implant placement will determine the percentage of newly formed bone, residual graft particles, and connective tissue within the specimen using calibrated image analysis software
Measured: 6 months post-operative (at implant placement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start21 Oct 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge PreservationStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Three-arm parallel-group randomized clinical trial comparing two types of allogeneic dentin grafts with a control group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre, Egypt
- Responsible party
- Principal investigator, Ahmed Abdelhamid Musa Abdelaziz, Kafrelsheikh University
- Investigators
- Enas Elgendy, PhD, Study chair, Faculty of Dentistry, Kafrelsheikh UniversityAhmed Elgendy, PhD, Principal investigator, Faculty of Dentistry, Kafrelsheikh UniversityAbir El-Mouelhy, PhD, Principal investigator, National Research Centre, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242313
- Sponsor's protocol ID
- KFSIRB200-718
- Acronym
- DDG-ARP
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Demineralized and Mineralized Allogeneic Dentin Grafts for Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07242313
- Acronym / sponsor ID
- DDG-ARP / KFSIRB200-718
- Keywords
- Alveolar Ridge Preservation, Socket Preservation, Post-Extraction Bone Loss, Dentin Graft, Allogeneic Dentin, Demineralized Dentin Matrix, Mineralized Dentin Graft, Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Collaborators
- National Research Centre, Egypt
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 21 Nov 2025 (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 clinical investigation aims to assess how two different allogeneic dentin graft materials - one de-mineralized and the other mineralized - influence bone preservation following extraction of a single upper posterior tooth. A total of 45 patients will be randomly allocated into three equal groups: a socket-only spontaneous healing group (control), a de-mineralized dentin graft group, and a mineralized dentin graft group. Over a six-month period after extraction, measurements will be taken using CBCT to monitor changes in ridge width, height, and bone density. Secondary outcomes include patient-reported pain, postoperative swelling, satisfaction levels, width of keratinized tissue, and histomorphometric data from biopsy samples at implant placement. Findings from this trial may support evidence-based decisions in alveolar ridge preservation and help clinicians choose the most predictable grafting strategy before implant placement.
Detailed description
The alveolar ridge experiences rapid remodeling after tooth extraction, often resulting in significant bone loss if no graft is placed. Clinical observations indicate that an extraction site may lose roughly half of its original width within six to twelve months, severely reducing the bone available for future implants or prosthetic support. This resorption occurs because removal of the tooth and its periodontal ligament eliminates the normal mechanical stimulation that maintains the surrounding bone. Alveolar ridge preservation techniques aim to counteract this remodeling by placing a graft in the extraction socket to maintain bone dimensions and support healing. Preserving the ridge anatomy in this way is critical for subsequent restorative procedures such as dental implant placement or denture support.
In practice, a variety of graft materials have been used to support alveolar ridge preservation. Autogenous bone grafts (harvested from the patient's own body, for example from the iliac crest or intraoral sites) have osteogenic and osteoinductive properties, but require a second surgical site and provide limited graft volume. Alternative materials include allogeneic bone (processed human bone from donors) and xenogeneic bone (such as bovine-derived hydroxyapatite), which are readily available but may integrate more slowly and raise concerns about immune reaction or disease transmission. Synthetic or alloplastic graft materials (calcium phosphates, bioactive glasses, polymers, etc.) are also used, although they typically act only as osteoconductive scaffolds and may not match the biologic activity of natural tissues. Given these limitations, there is ongoing interest in novel graft sources that can offer both safety and biological efficacy.
One promising graft material is dentin, the calcified tissue comprising the bulk of a tooth beneath the enamel. Chemically, dentin closely resembles bone: it is roughly 70% mineral (hydroxyapatite) and 20% organic matrix (predominantly type I collagen) by weight, along with non-collagenous proteins and embedded growth factors. Because dentin is acellular and avascular, it is inherently well-tolerated when used as a graft. Importantly, its organic matrix contains signaling molecules such as bone morphogenetic proteins (BMPs) and other growth factors that are naturally osteoinductive. In clinical practice, an extracted tooth can be cleaned and converted into graft material by grinding it into particulate form or shaping it into a block. Clinical studies have shown that autogenous tooth-derived grafts (using a patient's own extracted tooth) can effectively support socket preservation and guided bone regeneration. However, this approach is limited by the availability of teeth in each patient and by variability in processing methods, which can affect the consistency of the graft material.
Dentin grafts can be prepared in different forms. Demineralized dentin matrix (DDM) is produced by treating the dentin with acid to remove most of the mineral phase, leaving a collagen-rich matrix that retains the dentin's organic proteins and growth factors. DDM is highly osteoinductive: by removing the crystalline mineral, the embedded signaling molecules (such as BMPs and transforming growth factors) are exposed, creating a bioactive scaffold that strongly stimulates new bone formation. In contrast, a fully mineralized dentin graft (for example, ground whole tooth particles that are not demineralized) retains the hydroxyapatite content, which contributes rigidity and initial volume stability. These mineralized grafts act primarily as an osteoconductive scaffold and release bioactive molecules more slowly as they resorb. In practical terms, demineralized dentin grafts are believed to accelerate early bone ingrowth, whereas mineralized dentin grafts may better preserve the initial socket architecture and support gradual long-term remodeling.
Allogeneic dentin grafts are obtained from healthy human donor teeth that have been processed and sterilized under controlled conditions. The use of donated extracted teeth provides a scalable graft source and repurposes material that would otherwise be discarded. Processing typically involves cleaning away any attached soft tissues, removing enamel and cementum, and grinding the remaining tooth structure into particles. Sterilization (for example by freeze-drying, gamma irradiation, or other validated methods) ensures the graft is safe for implantation. For demineralized allografts, an additional acid step is applied to decalcify the particles. These preparation steps remove or inactivate cells and pathogens, minimizing immunogenic components. Preclinical studies suggest that properly processed allogeneic dentin matrix can induce bone formation with minimal immune reaction or rejection. However, standardized clinical evidence on allogeneic dentin grafts remains limited.
Given this background, the current trial is designed to determine which graft preparation yields better ridge preservation outcomes. Both demineralized and mineralized allogeneic dentin grafts are expected to support bone healing, but they may influence the process differently. Demineralized allogeneic dentin grafts, with their exposed collagen matrix and retained growth factors, may encourage rapid initial bone ingrowth. Mineralized allogeneic dentin grafts may offer greater immediate structural support and preserve socket volume over time, although they tend to release growth factors more slowly. The comparative performance of these two graft types in humans has not been established, creating a clear need for a controlled clinical study.
This randomized controlled clinical trial will enroll patients undergoing single-tooth extraction who require ridge preservation. Patients will be randomly assigned to receive either a demineralized allogeneic dentin graft or a mineralized allogeneic dentin graft placed into the fresh extraction socket. In each case the graft material will be placed immediately after extraction and the site will be closed using standard surgical technique. Both groups will follow the same postoperative care and follow-up protocol. After a predetermined healing interval (for example, three to six months), the sites will be re-entered for evaluation. Assessment will include clinical inspection and radiographic imaging of the ridge, and if feasible histological analysis of any newly formed bone, to compare bone volume and architecture between the two graft types.
This study addresses a gap in current clinical evidence, as no published trials have directly compared demineralized and mineralized human dentin grafts for socket preservation. Prior research has shown that autologous tooth-derived grafts can be effective for ridge preservation, but the optimal approach for donated (allogeneic) dentin remains uncertain. The findings of this trial will provide evidence-based guidance on graft material selection in extraction site management. If one graft type proves superior, this would validate the use of donated human teeth as a sustainable and effective bone graft source, potentially reducing reliance on animal-derived or synthetic substitutes. Ultimately, optimizing socket grafting methods is expected to enhance outcomes in implant and prosthetic dentistry by preserving bone anatomy and facilitating successful restorative treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm parallel-group randomized clinical trial comparing two types of allogeneic dentin grafts with a control group.
| Arm | Type | Receives |
|---|---|---|
| Demineralized Allogeneic Dentin Graft | Experimental | Biological: Demineralized Allogeneic Dentin GraftAfter atraumatic tooth extraction, the socket is filled with demineralized allogeneic dentin particulate graft. The material is processed and sterilized according to standardized laboratory protocols. A resorbable collagen dressing is placed over the graft, followed by site closure. This arm evaluates the regenerative effectiveness of demineralized dentin on ridge preservation. |
| Mineralized Allogeneic Dentin Graft | Experimental | Biological: Mineralized Allogeneic Dentin GraftFollowing atraumatic extraction, the socket is grafted with mineralized allogeneic dentin particulate material processed and sterilized under controlled conditions. A resorbable collagen dressing is applied prior to closure. This arm assesses the ridge preservation outcomes produced by the mineralized form of dentin graft. |
| Control: Spontaneous Healing (Empty Socket) | No intervention | –Participants in this arm undergo atraumatic tooth extraction followed by natural socket healing without graft placement. The socket is allowed to heal spontaneously to serve as the control for evaluating dimensional bone changes relative to grafted groups. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults aged 18 to 60 years.
- Medically healthy patients classified as ASA I.
- Presence of a single non-restorable tooth indicated for extraction in the posterior maxilla.
- Adequate oral hygiene, with plaque and bleeding indices both below 20%.
- Sufficient bone volume to allow socket preservation without requiring simultaneous augmentation.
Key exclusion criteria (9 listed)
- Smokers or tobacco users of any form.
- Presence of uncontrolled systemic diseases (e.g., uncontrolled diabetes).
- Conditions affecting bone metabolism (e.g., osteoporosis, long-term corticosteroid therapy).
- Pregnant or lactating women.
- History of radiotherapy in the head and neck region.
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 Allogeneic Dentin GraftParticulate demineralized allogeneic dentin processed from donor teeth using standardized laboratory protocols, including cleaning, defatting, demineralization, dehydration, freeze-drying, and sterilization. The graft is placed into the extraction socket following atraumatic extraction, covered with a resorbable collagen dressing, and the site is closed to promote alveolar ridge preservation. | Biological | Demineralized Allogeneic Dentin Graft |
| Mineralized Allogeneic Dentin GraftParticulate mineralized allogeneic dentin derived from processed donor teeth. The dentin is cleaned, defatted, ultrasonically treated, dehydrated, freeze-dried, and sterilized while retaining its mineral phase. The graft is inserted into the extraction socket after atraumatic extraction and covered with a resorbable collagen material prior to closure to support ridge preservation. | Biological | Mineralized Allogeneic Dentin Graft |
Primary outcome
Change in Alveolar Ridge Width (Buccolingual Dimension)
Time frame: Baseline (immediately after extraction) and 6 months post-operative
Measurement of the buccolingual width of the alveolar ridge using standardized Cone-Beam Computed Tomography (CBCT). Width is measured at predetermined reference points to assess dimensional bone changes following grafting.
Change in Alveolar Ridge Height (Vertical Dimension)
Time frame: Baseline and 6 months post-operative
Vertical height of the alveolar ridge measured radiographically on CBCT at standardized anatomical landmarks to quantify bone height changes over the healing period.
Bone Density at the Grafted Site
Time frame: 6 months post-operative
Bone density at the extraction site measured using CBCT expressed in Hounsfield Units (HU) to evaluate bone quality gained after grafting
5 secondary outcomes
Postoperative Pain Levels (VAS Score)
Time frame: 24, 48, and 72 hours post-operative
Postoperative swelling
Time frame: Baseline (preoperative), 24, 48, and 72 hours post-operative
Patient Satisfaction Score
Time frame: 6 months post-operative
Width of Keratinized Tissue
Time frame: Baseline and 6 months post-operative
Histomorphometric Analysis of Bone Core Biopsies
Time frame: 6 months post-operative (at implant placement)
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 24 Nov 2025.
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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.
Enas Elgendy, PhD study chair
Faculty of Dentistry, Kafrelsheikh University
Ahmed Elgendy, PhD principal investigator
Faculty of Dentistry, Kafrelsheikh University
Abir El-Mouelhy, PhD principal investigator
National Research Centre, Cairo, 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 Allogeneic Dentin Graft and Mineralized Allogeneic Dentin Graft in people with Alveolar Ridge Preservation and Post Extraction Alveolar Bone Resorption, run by Kafrelsheikh 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 9 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 24 Nov 2025. 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 Ahmed Abdelaziz, BDS, MSc candidate (+201157315278, ahmed.mousa@den.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alveolar Ridge Width (Buccolingual Dimension) (time frame: Baseline (immediately after extraction) and 6 months post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2025.