DDG-ARP
Comparative Study Between Demineralized and Mineralized Allogeneic Dentin Grafts for Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
Sponsor study identifier
interventional
45
1 country
1
Study Start
October 21, 2025
Actual (reported)Primary Completion
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2025
Actual (reported)November 17, 2025
Actual (reported)November 21, 2025
Actual (reported)August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
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
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.
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.
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.
Faculty of Dentistry, Kafrelsheikh University
Kafr ash Shaykh, Egypt
Enas Elgendy, PhD
Faculty of Dentistry, Kafrelsheikh University
Ahmed Elgendy, PhD
Faculty of Dentistry, Kafrelsheikh University
Abir El-Mouelhy, PhD
National Research Centre, Cairo, Egypt
First Submitted
November 17, 2025
First Posted
November 21, 2025
Study Start
October 21, 2025
6 months post-operative
Postoperative Pain Levels (VAS Score)
24, 48, and 72 hours post-operative
Postoperative swelling
Baseline (preoperative), 24, 48, and 72 hours post-operative
Patient Satisfaction Score
6 months post-operative
Width of Keratinized Tissue
Baseline and 6 months post-operative
Histomorphometric Analysis of Bone Core Biopsies
6 months post-operative (at implant placement)
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.
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.
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Primary Completion
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 24, 2025
Record last verified: 2025-11
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Source: ClinicalTrials.gov.
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