Post Extraction Alterations Following Ridge Preservation In The Esthetic Zone Using Partially Demineralized Autogenous Dentine Graft Versus Xenograft
NCT Number: NCT06552793
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Socket Preservation
Interventions: BIOLOGICAL: autogenous partially demineralized dentin graft|BIOLOGICAL: Xenograft
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 23
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2025-02-01
Locations: Faculty of Dentistry Cairo University, Cairo, Egypt

Summary:
the aim of this study is to establish if there are clinical, radio-graphical and histomorphometrical differences between using Partially Demineralized Dentin graft versus Xenograft in the esthetic zone. 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. After extraction of non-restorable teeth in the esthetic zone, will ridge preservation with application of partially demineralized autogenous dentin graft produce less hard tissue changes compared to xenograft?

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. Flapless and atraumatic tooth extraction will be initiated, Then the sockets will be carefully packed with the allocated graft material that are shaped to match the individual size and contours of each socket. Once the grafts are properly adapted to the sockets, they will be covered with collagen membrane. The membrane will be shaped to extend 2-3 mm beyond the margins of the extraction socket and positioned just beneath the marginal mucosa. To ensure its stability, a cross-suture will be performed, securing the membrane in place.

Intervention group: The socket will be filled with partially demineralized autogenous dentin graft Control group: The socket will be filled with xenograft . 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 radiographic horizontal ridge width at 1mm below the most coronal aspect of the crest , Change in radiographic horizontal ridge width at 3 and 5mm below the most coronal aspect of the crest,Change in radiographic buccal ridge height , Change in radiographic buccal ridge height ,Change in radiographic Palatal ridge height,Percentage of new vital bone formation,Percentage of residual bone graft,Implant Primary Stability.

Detailed Description: This study aims to evaluate clinical, radiographic and histomorphometrica

Primary Outcome Measures: Change in radiographic horizontal ridge width, CBCT scans will be performed at baseline and 6 months postoperatively. Measurements will be taken at both time points using identical reference points and lines. To establish a reference, the most apical point of the extraction socket will be identified on the baseline image, and two reference lines will be drawn. The vertical reference line will be placed at the midpoint of the extraction socket, intersecting the apical reference point. Additionally, a horizontal reference line will be drawn perpendicular to the vertical line, passing through the apical reference point.The horizontal ridge width will be measured at three specific levels: 1 mm, 3 mm, and 5 mm below the most coronal aspect of the crest. These measurements will be denoted as HW-1, HW-3, and HW-5, respectively., after 6 months postoperatively
Secondary Outcome Measures: Change in radiographic buccal and palatal ridge height:, CBCT scans will be performed at baseline and 6 months postoperatively. Measurements will be taken at both time points using identical reference points and lines. To establish a reference, the most apical point of the extraction socket will be identified on the baseline image, and two reference lines will be drawn. The vertical reference line will be placed at the midpoint of the extraction socket, intersecting the apical reference point.

The height of the alveolus will be measured at the midbuccal aspect (BH) and midlingual aspect (LH)., after 6 months postoperatively.|Percentage of new vital bone formation and residual graft, The biopsies will be stored in a 10% formalin solution for preservation.they will undergo decalcification in EDTA for a duration of four weeks. Following decalcification, the specimens will be processed and embedded in paraffin to create tissue blocks. Longitudinal sections of 5μm thickness will be cut from the paraffin blocks.stained using hematoxylin and eosin (H\&E) or Masson's trichromatic (MT) stains for histological evaluation and histomorphometric analysis. Photomicrographs of the stained sections will be captured using a digital light microscope. Histomorphometric analysis will be performed to quantify the area percentage occupied by bone, graft particles, and soft tissue stroma relative to the total examined histological area using Image analyzer software.The software will be calibrated to automatically convert the measurement units produced by the program into actual micrometer units for accurate quantification., after 6 months postoperatively|Implant Primary Stability, The primary stability of the implant fixture will be assessed using the Osstell Mentor Resonance Frequency Analyzer (Osstell AB, Goteborg, Sweden). Two measurements will be taken in the buccolingual and mesiodistal directions for each implant. The average of these two measurements will be recorded as the representative implant stability quotient (ISQ) for each individual implant., after 6 months postoperatively