Evaluation of Dentin Graft and I-PRF With and Without Vitamin C for Post-extraction Socket Preservation
NCT Number: NCT06569264
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Socket Preservation
Interventions: PROCEDURE: Alveolar ridge preservation using autogenous demineralized dentin graft and i-PRF|PROCEDURE: Alveolar ridge preservation using vitamin C with dentin graft and i-PRF
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-04-01
Locations: Faculty of Dentistry, Cairo University, Cairo, Egypt

Summary:
The aim of the study is to clinically and radio graphically evaluate marginal bone loss following autogenous demineralized dentin graft (ADDG) and i-PRF addition with and without vitamin C (AA) for post extraction socket preservation.

The main question is:

In patient with non-restorable teeth, does adding vitamin C to dentin graft and i-PRF affect the marginal bone loss of post extraction sockets?

Intervention group:

Alveolar ridge preservation using vitamin C (AA) with autogenous demineralized dentin graft combined with i-PRF.

Adding vitamin C to dentin graft and i-PRF might aid in reducing the dimensional changes and marginal bone loss, since it increases osteoblast proliferation and viability during socket preservation. Layers of osteoblast cell morphology can be seen at day 11 with the presence of 25mM of vitamin C. By adding vitamin C to i-PRF we can add the advantages of improving soft tissue quality as well.

Control group:

Alveolar ridge preservation using autogenous demineralized denting graft combined with i-PRF. Dentin particle can be used as an excellent autogenous graft material to replace other autogenous graft materials, it can be used in socket preservation. as it enhances bone formation, and has shown an ability to maintain the alveolar ridge dimensions because of its osteo-conductive properties. Moreover, dentin graft is used as a cost-effective grafting material during socket preservation.

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 the corresponding graft material, and an absorbable gelatin sponge (gelfoam) will be used for socket and graft material coverage and secured using an internal crisscross knot using 5-0 monofilament polypropylene suture material.

Primary Outcome Measures: Marginal bone level, The bone level will be measured from the implant shoulder to the first bone-implant contact, from all 4 surfaces(mesial, distal, buccal, and lingual/palatal), measured by CBCT scans, after 6 months postoperatively.
Secondary Outcome Measures: Buccolingual 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 measured at a level of 2 mm below the most coronal cross section and perpendicular to the vertical reference line, after 6 months postoperatively.|Buccal and lingual 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 newly formed bone, Histomorphometric analysis will be performed by quantifying the area percentage occupied by bone, graft particles, and soft tissue stroma relative to the total examined histological area using image analyzer software. The image analyzer will be calibrated to automatically convert the measurement units (pixels) produced by the image analyzer program into actual micrometer units. In both groups, the area percentage of newly formed bone will be estimated in three successive regions of the defect, where region two represented the center of the biopsy, using a magnification of x100., after 6 months postoperatively.|Histological evaluation of residual graft in human biopsies, eight bone biopsies (four from each group) will be obtained six months following engraftment. During implant placement in grafted sites, trephine bur with an outer diameter of 3.3mm, an inner diameter of 2.8mm and a depth of 6-8mm will be used. The biopsies will be stored in 10% formalin solution, decalcified in EDTA for four weeks, processed and embedded in paraffin forming tissue blocks. The paraffin blocks will be cut longitudinally into sections of 5μm thickness will be cut from the paraffin blocks and stained using hematoxylinand eosin (H\&E) or Masson's trichromatic (MT) stains for histological evaluation and histomorphometric analysis. Photomicrographs will be taken using a digital light microscope., after 6 months postoperatively.|Patient reported outcomes, absence of pain under vertical or horizontal forces using a visual analog scale (0-10)., baseline, 2 weeks, 1 month and 6 months postoperatively.