Evaluation Of Post Extraction Hard Tissue Alteration Following Ridge Preservation in The Esthetic Zone Using Allogeneic Dentin Matrix Versus Autogenous Partially Demineralized Dentine Matrix: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Radiographic bucco-lingual ridge width loss
Study Overview
Brief 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.
Detailed Description
This study aims to evaluate the radiographical and histomorphometrical differences between the allogenic dentin matrix and the autogenous partially demineralized dentin matrix (APDDM) in ridge preservation after tooth extraction in the aesthetic zone.
Research Procedure:
Patients will be selected from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry, Cairo University. General operative procedures: The patients who fulfil the inclusion criteria will be enrolled. The nature of the study will be explained to each patient as follows: as well as the importance of compliance with pre- and post-operative instructions.
and follow-up visits. Each patient will be asked to sign an informed consent form. After enrolment, periodontal and radiographic examination and Patients with badly unrestorable teeth in the aesthetic zone will be identified.
These patients will undergo mesio-distal distance between adjacent teeth. corono-apical height of bone, presence of labial undercut, dehiscence, or fenestration and relation to adjacent teeth measurements using transgival probing technique, and a preapical radiograph, or CBCT. Initial Therapy: The initial therapy will consist of periodontal treatment. (phase I therapy), including supra-gingival scaling and subgingival debridement if needed, adjustment of faulty restoration, and polishing. The mechanical plaque Control instructions for each patient include brushing and interdental cleaning.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
- •Patients accept a 6-month follow-up period (cooperative patients).
- •Patients provide informed consent.
Exclusion Criteria
- •Patients reporting systemic conditions that may compromise healing (e.g., uncontrolled diabetes).
- •Patients with poor maintenance of oral hygiene.
- •Pregnancy.
- •Patients taking any medications that could compromise healing.
Outcomes
Primary Outcomes
Radiographic bucco-lingual ridge width loss
Time Frame: after 6 months of the surgery
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.
Secondary Outcomes
- Percentage of new vital bone formation and residual graft:(after 6 months of the surgery)
- Implant Primary Stability(after 6 months of the surgery)
- Change in the radiographic vertical bone level(after 6 months of the surgery)
Investigators
Abdullah Matar Sead Alharthi
Princible Investigator, Master Degree Student, Periodontology Department, Faculty of Dentistry, Cario University
Cairo University