About this trial
The aim of the study is to evaluate radiographic ridge width change 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 radiographic ridge width 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, 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥ 18 years of age.
Single extraction of non-molar teeth with periodontally healthy adjacent teeth.
Non-contributory medial history.
Non- restorable teeth indicated for extraction.
Disqualifiers
Pregnant female.
Acute infection at extraction site.
Systemic conditions affecting healing (e.g., diabetes, medications as bisphosphonates...)
A participant who had radiotherapy or chemotherapy.
Trial design
Parallel
Treatments tested in this trial
Alveolar ridge preservation using autogenous demineralized dentin graft and i-PRF
Procedure/SurgeryFlapless atraumatic extraction. After thorough mechanical cleaning, the sockets will be rinsed with 5 ml of an aqueous 0.125% chlorhexidine digluconate solution, followed by a 5 ml sterile saline rinse to remove tissue debris from the socket. Followed by inspection of extraction socket integrity, using a William's graduated periodontal probe. Extracted teeth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries or restorations using a high-speed fine finishing stone and saline irrigation. The pulp chamber will be cleaned with sterile endodontic files. Teeth will be ground, using hand bone mill. The (ADDG) particles prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralized then washed twice in saline and dried with sterile gauze. The ADDG will be collected in a sterile plastic syringe. For the preparation of i-PRF, 10 mL of venous blood will be drawn into a PET tube and centrifuged at 700rpm for 3 min.
Alveolar ridge preservation using vitamin C with dentin graft and i-PRF
Procedure/SurgeryFlapless atraumatic extraction. After thorough mechanical cleaning, the sockets will be rinsed with 5 ml of an aqueous 0.125% chlorhexidine digluconate solution, followed by a 5 ml sterile saline rinse to remove tissue debris from the socket. The ADDG particles will be collected in a sterile plastic syringe. For the preparation of i-PRF, 10 mL of venous blood will be drawn into a sterile PET tube and centrifuged at 700 rpm for 3 minutes. The resulting i-PRF liquid layer will then be aspirated from the top of the tube and transferred into the syringe containing the ADDG particles. 25 mM of pure vitamin C , drawn using a micropipette, will be aspirated into the same syringe containing the ADDG-i-PRF mixture. The combined mixture will then be allowed to set for 10 minutes to produce the sticky ADDG.
Treatment groups
Trial outcomes
Primary outcomes
Radiographic ridge width change
To ensure the primary outcome directly reflects the biological effect of socket preservation and to avoid confounding introduced by implant surgery and loading, the primary outcome has been refined to radiographic horizontal ridge width change measured at baseline and follow-up timepoints. The difference from baseline to 3 months follow-up in the radiographic bucco palatal ridge width. CBCT scans will be performed at baseline and 3 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
Secondary outcomes
Buccal ridge height
CBCT scans will be performed at baseline and 3 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)
Lingual ridge height
CBCT scans will be performed at baseline and 3 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 midlingual aspect (LH).
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.
Histological evaluation of residual graft in human biopsies
eight bone biopsies will be obtained 3 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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.