Comparative Study Between Demineralized and Mineralized Allogeneic Dentin Grafts for Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Faculty of Dentistry, Kafrelsheikh University
RECRUITING
Kafr Ash Shaykh
Contact Information
Primary
Ahmed Abdelaziz, BDS, MSc candidate
ahmed.mousa@den.kfs.edu.eg
+201157315278
Backup
Enas Elgendy, PhD
enas_ahmed@den.kfs.edu.eg
+201003508797
Time Frame
Start Date: 2025-10-21
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 45
Treatments
Experimental: Demineralized Allogeneic Dentin Graft
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.
Experimental: Mineralized Allogeneic Dentin Graft
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.
No_intervention: Control: Spontaneous Healing (Empty Socket)
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.
Related Therapeutic Areas
Sponsors
Leads: Kafrelsheikh University
Collaborators: National Research Centre, Egypt

This content was sourced from clinicaltrials.gov

Similar Clinical Trials