Comparison of Demineralized and Mineralized Dentin Grafts in Ridge Preservation

NCT07242313 | Recruiting

• 1 other identifier: KFSIRB200-718
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Ridge Preservation; Post Extraction Alveolar Bone Resorption

Keywords

Alveolar Ridge Preservation; Socket Preservation; Post-Extraction Bone Loss; Dentin Graft; Allogeneic Dentin; Demineralized Dentin Matrix; Mineralized Dentin Graft; Bone Regeneration; Histomorphometry

Outcome Measures

Primary Outcomes (3)

• 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

  6 months post-operative

Secondary Outcomes (5)

• 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)

Study Arms (3)

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.

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.

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.

Interventions

Demineralized Allogeneic Dentin Graft BIOLOGICAL

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.

Demineralized Allogeneic Dentin Graft

Mineralized Allogeneic Dentin Graft BIOLOGICAL

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.

Mineralized Allogeneic Dentin Graft

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead
• National Research Centre, Egypt: collaborator

Study Sites (1)

Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, Egypt

RECRUITING

Study Officials

• Enas Elgendy, PhD

  Faculty of Dentistry, Kafrelsheikh University

  STUDY CHAIR

• Ahmed Elgendy, PhD

  Faculty of Dentistry, Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

• Abir El-Mouelhy, PhD

  National Research Centre, Cairo, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Abdelaziz, BDS, MSc candidate

CONTACT

+201157315278; ahmed.mousa@den.kfs.edu.eg

Enas Elgendy, PhD

CONTACT

+201003508797; enas_ahmed@den.kfs.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, outcome assessors, and the statistician are blinded to group allocation. Care providers are blinded to graft type in the demineralized and mineralized groups but not in the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student, Department of Periodontology, Faculty of Dentistry, Kafrelsheikh University

Model Details: Three-arm parallel-group randomized clinical trial comparing two types of allogeneic dentin grafts with a control group.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

EG (1)