Demineralized versus mineralized dentin grafts to preserve the upper back tooth ridge
Comparative Study Between Demineralized and Mineralized Allogeneic Dentin Grafts for Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
We will test whether demineralized or mineralized donor dentin grafts better preserve bone after removing a single upper back tooth in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Kafrelsheikh University Academic / other |
| Locations | 1 site (Kafr ash Shaykh) |
| Trial ID | NCT07242313 on ClinicalTrials.gov |
What this trial studies
This randomized trial will assign 45 adults needing a single posterior maxillary extraction into three groups: spontaneous socket healing (control), demineralized allogeneic dentin graft, or mineralized allogeneic dentin graft. Clinicians will place the assigned treatment at the time of extraction and follow patients for six months. Cone beam CT (CBCT) will measure changes in ridge width, height, and bone density, and clinicians will collect biopsies at implant placement for histomorphometric analysis. Secondary outcomes include patient-reported pain, swelling, satisfaction, and keratinized tissue width.
Who should consider this trial
Good fit: Adults aged 18–60 who are medically healthy (ASA I), have a single non-restorable posterior maxillary tooth to be extracted, maintain good oral hygiene, and can attend follow-up visits are ideal candidates.
Not a fit: Smokers, pregnant or lactating women, people with uncontrolled systemic disease or bone metabolism disorders, and those needing larger simultaneous augmentation are unlikely to benefit from this specific protocol.
Why it matters
Potential benefit: If successful, the results could help clinicians choose a graft material that better preserves bone and makes later implant placement more predictable.
How similar studies have performed: Small clinical reports and preclinical studies of demineralized dentin matrices have shown promising bone preservation, but randomized head-to-head comparisons of demineralized versus mineralized allogeneic dentin are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Where this trial is running
Kafr ash Shaykh
- Faculty of Dentistry, Kafrelsheikh University — Kafr ash Shaykh, Egypt (Recruiting)
Study contacts
- Principal investigator: Ahmed Elgendy, PhD — Faculty of Dentistry, Kafrelsheikh University
- Study coordinator: Ahmed Abdelaziz, BDS, MSc candidate
- Email: ahmed.mousa@den.kfs.edu.eg
- Phone: +201157315278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.