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the aim of this study is to establish if there are clinical, radio-graphical and histomorphometrical differences between using Allogenic Demineralized Dentin matrix versus Demineralized Freeze-Dried Bone Allograft (DFDBA) as a clinical application in alveolar bone regeneration procedures related to implant dentistry, including socket preservation, alveolar ridge augmentation, after tooth extraction in the esthetic zone.Will ridge preservation using Allogeneic Dentin Matrix be more effective than Demineralized Freeze-Dried Bone Allograft in managing the post extraction hard tissue alterations?
The initial therapy consists of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. alginate impression will be taken to fabricate an acrylic stent to be used as reference for measurements of width of ridge clinically.
Flapless and atraumatic tooth extraction will be initiated, Then the socket will be filled either with Allogeneic Dentin Matrix or Demineralized freeze-dried bone allograft (DFDBA) up to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. criss-cross horizontal mattress suturing technique
Intervention group: The socket will be filled with Allogeneic Dentin Matrix Control group: The socket will be filled with Demineralized freeze-dried bone allograft (DFDBA).
For both groups, All the subjects will be evaluated at pre-surgical, baseline and 6 months post surgical months for clinical parameters and baseline( immediate post-surgical and 6 months post-surgical . Outcomes: Change in ridge width clinically after 6 months, Change in the radiographic buccal vertical bone level, Change in the radiographic palatal vertical bone level,Change in the radiographic horizontal bone level,Percentage of new vital bone formation,Percentage of residual bone graft and Implant Primary Stability.
This study aims to evaluate clinical, radiographic and histomorphometrical differences between using Allogenic Demineralized Dentin matrix versus Demineralized Freeze-Dried Bone Allograft (DFDBA) in alveolar ridge preservation after tooth extraction in the esthetic zone.
Research Procedure in brief:
The study is to be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry- Cairo University, Egypt.Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology, clinic of the department of Oral surgery and clinic of the department of Endodontics -Cairo University.
The initial therapy consists of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques.
surgical interventions: Atraumatic extraction.The patient will rinse their mouth with 0.12% Chlorhexidine Administration of 4% articaine hydrochloride with 1:100,000 epinephrine will be as local anesthetic agent.Flapless and atraumatic tooth extraction will be initiated, using 15C blade intrasulcular incision will be performed.A periotome will be utilized to sever the periodontal ligament (PDL) fibers, followed by extraction witha straight elevator and extraction forceps.
Test group:
preparation of Allogenic Demineralized Dentin Matrix. Extracted teeth will be collected from the Departments of oral maxillofacial surgery and periodontics, Cairo university. Cleaning the teeth from any caries, Filings, cement, tartar, soft tissue debris and prosthetic components will be performed using a diamond bur under abundant irrigation with physiological water. Then it will be proceeded to the following steps
Alveolar ridge preservation:
Postoperative Care and follow up:
Biopsy collection After a 6-months healing period, a biopsy will be collected from the central area of the grafted site with a 3- mm trephine bur at the time of implant implantation. The biopsy will be immediately fixed in 10% neutral buffered formalin, followed by dehydration in a series of increasing concentration alcohol baths (varying from 50% to 100%). The specimen will then be encased in paraffin. Finally, a 4 m thick tissue section will be cut and stained with hematoxylin and eosin for subsequent histological investigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogenic Demineralized Dentin Matrix | Experimental | Following atraumatic tooth extraction, curettes will be used to remove granulation tissues, and the socket will be irrigated with sterile normal saline.Then the socket will be filled with Allogeneic Dentin Matrix (that has been prepared before) to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. Suturing technique will be a criss-cross horizontal mattress to ensure that most of the grafting material is covered. |
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| Demineralized Freeze-Dried Bone Allograft | Active Comparator | Following atraumatic tooth extraction, curettes will be used to remove granulation tissues, and the socket will be irrigated with sterile normal saline.Then the socket will be filled with Demineralized freeze-dried bone allograft (DFDBA) to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. Suturing technique will be a criss-cross horizontal mattress to ensure that most of the grafting material is covered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Demineralized Dentin Matrix | Biological | preparation of Allogenic Demineralized Dentin Matrix: Extracted teeth will be collected from the Departments of oral maxillofacial surgery and periodontics, Cairo university. Cleaning the teeth from any caries, Filings, cement, tartar, soft tissue debris and prosthetic components will be performed using a diamond bur under abundant irrigation with physiological water. Then it will be proceeded to the following steps 1. (Washing with Distilled water ) 2. (Quick Freezing with liquid nitrogen, then Grinding to particle size of 300- 800 μm). 3.(Ultrasonic Cleaning cycles, 1st with Distilled water , 2nd with 5-7% Hydrogen Perioxide then 3rd with Distilled water for at 60-80 o) 4. (Defatting with Chloroform Methanol Solution1:0.5. 5. (Demineralization with0.5N HCL) 6. (Dehydration with Neutral Ethyl Alcohol then Defatting with Chloroform Methanol Solution 1:0.5 for ) 7. (Washing with Normal Saline & Freeze Drying then Sterilization using Ethylene oxide gas). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ridge width over 6 months | Before surgical intervention, baseline and 6-month postoperative examination will be conducted. Before surgical procedure ridge width will be measured using caliper, a resin acrylic stent will be placed measurements of 3mm and 5mm from gingival margin will be marked and measures the ridge width through it, this will be repeated after extraction (baseline) and 6 months postoperative. | after 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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 of the extraction socket.The alveolus' height will be measured at the midbuccal aspect (BH) and the midlingual aspect (LH). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manal M. Hosny, Professor | Cairo University | Study Director |
| Fatima M. Saleem Bin Nuhaid, Bachelor | Cairo University | Principal Investigator |
| Weam A. El-Battawy Study Chair, Ass. Prof. | Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry Cairo University | Cairo | 12613 | Egypt |
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| ID | Term |
|---|---|
| C093073 | Demineralized Dentin Matrix |
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A Randomized Controlled Clinical Trial
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| Demineralized freeze-dried bone allograft (DFDBA) | Biological | combination allograft, is a particulate bone graft combining 70% mineralized ground cortical with 30% demineralized ground cortical Particle sizing: 250 - 1000um. |
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| after 6 months postoperatively |
| Change in the radiographic horizontal bone level | CBCT scans will be performed at baseline and 6 months thereafter. 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 of the extraction socket. In addition, a horizontal reference line perpendicular to the vertical line will be drawn, passing through the apical reference point.The horizontal ridge width will be measured at three different levels: 1 mm, 3 mm, and 5 mm below the crest's most coronal aspect. These measurements will be denoted by the letters HW-1, HW-3, and HW-5. | after 6 months postoperatively |
| 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 5m 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. | after 6 months postoperatively |
| 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 postoperatively |