Post Extraction Changes Following Ridge Preservation Using Allogenis Dentin Vs Autogenous Partially Demineralized Dentin

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with good health status (ASA-1, ASA-2).

Adult patients over 18 years old.

Patients with non-restorable teeth in the aesthetic zone for periodontal, carious, or traumatic reasons.

Extraction socket with no more than 50% buccal bone loss.

Disqualifiers

Patients reporting systemic conditions that may compromise healing (e.g., uncontrolled diabetes).

Patients with poor maintenance of oral hygiene.

Pregnancy.

Smokers.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Allogeneic Dentin Matrix

    Biological/Vaccine

    Steps of Allogenic Dentin Processing: Wash with distilled water for 30-120 minutes. Ultrasonic Cleaning Cycles: 1st with distilled water for 5-10 minutes, 2nd with 5-7% hydrogen peroxide for 10-30 minutes, then the 3rd with distilled water for 5-10 minutes at 60-80. Defatting with Chloroform Methanol Solution 1:0.5 for 3-12 hours. Demineralization with 0.5N 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. Wash with normal saline and freeze dry, then sterilise using ethylene oxide gas. The extracted socket will be filled with allogenic dentin

  • Autogenous Partially Demineralized Dentine Matrix

    Biological/Vaccine

    The extracted tooth will be cleaned with a diamond bur under abundant irrigation with physiological water. All filling materials (gutta-percha, composite, luting cements, etc.) will be removed with the outmost care and under magnification. Subsequently, the tooth will be cut into fragments (5 × 5 mm) and inserted into the milling device (Tooth Transformer, Milan, Italy). According to the manufacturer, a disposable box containing disposable liquid solutions will be inserted into the device to ensure the demineralization of the graft with 0.1 M hydrochloric acid, 10% hydrogen peroxide, and demineralized water as a wash. After 25 minutes, particle graft biomaterials will be obtained. The particle size will range from 815 µm with peaks up to 1110 µm. The socket will be filled with the graft.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Allogeneic Dentin MatrixExperimental treatment 1 intervention
Group B: Autogenous Partially Demineralized Dentine MatrixActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
after 6 months of the surgery

Secondary outcomes

1

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).

Time frame
after 6 months of the surgery
2

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

Time frame
after 6 months of the surgery
3

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.

Time frame
after 6 months of the surgery

Other outcomes

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