Post Extraction Changes Following Ridge Preservation Using Allogenis Dentin Vs Autogenous Partially Demineralized Dentin
NCT Number: NCT06477887
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Socket Preservation
Interventions: BIOLOGICAL: Allogeneic Dentin Matrix|BIOLOGICAL: Autogenous Partially Demineralized Dentine Matrix
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-03
Completion Date: 2024-12
Locations: Cairo University, Cairo, Cairo, Elmanil, Egypt, 4240101, Egypt

Summary:
Research question:

In patients with unrestorable anterior teeth, will the use of allogenic dentin matrix be more effective than autogenous partially demineralized dentine matrix (APDDM) in reducing hard tissue changes after post-extraction ridge preservation in the aesthetic zone? After enrolment, periodontal and radiographic examinations will be conducted, and patients with badly unrestorable teeth in the aesthetic zone will be identified. These patients will undergo measurements of mesio-distal distance between adjacent teeth, corono-apical height of bone, the presence of a labial undercut, dehiscence, or fenestration, and the relationship to adjacent teeth using the transgival probing technique and a preapical radiograph, or CBCT.

In both groups, the desired tooth will be atraumatically extracted under local anaesthesia using peritomies and surgical forceps.

In the intervention group: preparation of the allogenic dentin matrix.

Steps of Allogenic Dentin Processing:

Washing with distilled water for 30-120 minutes Ultrasonic cleaning cycles: 1st with distilled water for 5-10 minutes, 2nd with 5-7% hydrogen peroxide 10-30 minutes, then 3 minutes with distilled water for 5-10 minutes at 60-80 Defatting with Chloroform Methanol Solution 1:0.5 for 3-12 hours. Demineralization with 0.5% HCL for 10-60 min Dehydration with Neutral Ethyl Alcohol for 30 minutes, then defatting with Chloroform Methanol Solution 1:0.5 for 3-12 hours Washing with normal saline and freeze-drying, then sterilisation using ethylene oxide gas.

After the recovery period of 6 months", a biopsy is taken for cases from the site of the operation for histological evaluation during implant placement.

• In the control group, the teeth will be cleaned and dried, and then the dentin will be ground to obtain particles of a certain size, which will be partially demineralized by using a tooth transformer machine. In both groups, the dentin graft will be placed inside the socket, and then a 5/0 proline suture will be used to fix the collagen membranes to cover the graft. After the recovery period of 6 months", a biopsy is taken for cases from the site of the operation for histological evaluation during implant placement.

Outcome:

Radiographic bucco-lingual ridge width loss. Radiographic palatal vertical bone changes. Radiographic buccal vertical bone changes. Percentage of new vital bone formation. Percentage of residual bone graft. Implant Primary Stability.

Primary Outcome Measures: Radiographic bucco-lingual ridge width loss, Baseline and 6-month postoperative CBCT scans will be conducted. At both time points, measurements will be taken with identical reference points and lines. Matched cuts of baseline and final scans were obtained at the mesio-distal centres of extraction sites, and both cuts were superimposed with the same dental reference for standardised measurements. A bisecting vertical reference line corresponding to the long axis of the alveolar ridge was placed in the centre of the extraction socket, and perpendicular horizontal reference lines were set at the most apical point of the extraction site. The BLRW was measured at a level of 2 mm below the most coronal cross section and perpendicular to the vertical reference.

line, and both BRH and LRH were measured parallel to the vertical reference line from the most coronal crest points each to the horizontal reference line.

Participant-level analysis metric: change from the baseline., after 6 months of the surgery
Secondary Outcome Measures: Change in the radiographic vertical bone level, Baseline and 6-month postoperative CBCT scans will be conducted. At both time points, measurements will be taken with identical reference points and lines. The most apical point of the extraction socket will be determined on the baseline image, and two reference lines will be created to form a reference. The vertical reference line will cross the apical reference point at the midway point of the extraction socket.

The alveolus' height will be measured at the midbuccal aspect (BH) and the midlingual aspect (LH)., after 6 months of the surgery|Percentage of new vital bone formation and residual graft:, The biopsies will be preserved in a 10% formalin solution. Following that, they will undergo four weeks of EDTA decalcification. The specimens will be treated and embedded in paraffin after decalcification to generate tissue blocks. The paraffin blocks will be split into longitudinal sections of 5 m in thickness. For histological examination and histomorphometric analysis, these slices will be stained with hematoxylin and eosin (H\&E) or Masson's trichromatic (MT) stains. A digital light microscope will be used to photograph the stained sections.

Histomorphometric analysis will be undertaken to determine the percentage of the total analysed histological area occupied by bone, graft particles, and soft tissue stroma. For this analysis, image analyzer software (Leica QWin 500 image analysis software, Leica Microsystems, Switzerland) will be used. To guarantee a neutral review, the pathologist will be blinded. The image analyzer programme, after 6 months of the surgery|Implant Primary Stability, Implant Primary Stability:

The Osstell Mentor Resonance Frequency Analyzer (Osstell AB, Goteborg, Sweden) will be used to evaluate the primary stability of the implant fixture. For each implant, two measurements will be collected in the buccolingual and mesiodistal directions. The representative implant stability quotient (ISQ) for each particular implant will be calculated as the average of these two measurements., after 6 months of the surgery