Health TrialsbyHealthPanel

Comparison of Demineralized and Mineralized Dentin Grafts in Ridge Preservation

ConditionsAlveolar Ridge PreservationPost Extraction Alveolar Bone Resorption
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKafrelsheikh University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Demineralized Allogeneic Dentin Graft

    Biological/Vaccine

    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 Graft

    Biological/Vaccine

    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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Demineralized Allogeneic Dentin GraftExperimental treatment 1 intervention
Group B: Mineralized Allogeneic Dentin GraftExperimental treatment 1 intervention
Group C: Control: Spontaneous Healing (Empty Socket)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (immediately after extraction) and 6 months post-operative
2

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.

Time frame
Baseline and 6 months post-operative
3

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

Time frame
6 months post-operative

Secondary outcomes

1

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.

Time frame
24, 48, and 72 hours post-operative
2

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.

Time frame
Baseline (preoperative), 24, 48, and 72 hours post-operative
3

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.

Time frame
6 months post-operative
4

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.

Time frame
Baseline and 6 months post-operative

Other outcomes

Sponsors and contacts

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Kafrelsheikh University

Lead sponsor

National Research Centre, Egypt

Collaborator

Source ClinicalTrials.gov
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