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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.
Research objective:
Socket preservation is one of the techniques utilized to maintain bone dimension and minimized post-extraction dimensional changes. 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. By adding vitamin C with i-PRF we can add the advantages of improving soft tissue quality as well. Layers of osteoblast cell morphology can be seen at day 11 with the presence of 25mM of vitamin C. Moreover, dentin graft is used as a cost-effective grafting material during socket preservation.
l. Inclusion criteria:
II. Exclusion criteria:
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. Rinsing with 0.12% chlorhexidine will be instructed.
Preoperative baseline cone-beam computed tomography (CBCT) scan will be conducted.
In both groups, tooth extraction under local anesthesia with articaine HCL 2%, 1:20,000 epinephrine will be performed. Flapless minimally traumatic extraction will be done using thin periotomes and luxators. 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. This procedure will be repeated three times for each socket. Followed by inspection of extraction socket integrity, using a William's graduated periodontal probe. Then, extracted teeth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries or restorations (if present), using a high-speed fine finishing stone and saline irrigation. The pulp chamber will be cleaned with sterile endodontic files. Subsequently, teeth will be ground, using hand bone mill.
The demineralized autogenous tooth graft (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.
For i-PRF preparation, blood will be withdrawn in plastic tubes without anticoagulant.
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 (60 g-force) 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. For the intervention group 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.
The extraction socket will be filled 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.
Postoperative care and follow up:
Patient will be instructed to abstain from trauma on the operative site, not to interfere with the suture and to avoid hot food or vigorous rinsing.
The patients will be advised to refrain from brushing at the surgical area for the first day after surgery.
A soft surgical brush will be dispensed for the cleaning of the surgical area after the initial healing phase during the first 2 weeks post surgically.
Antibiotics and analgesics will be prescribed for 5 days.
Patients will be instructed to:
The sutures will be removed two weeks after the surgery. A final follow-up visit and CBCT scan will be scheduled for three months postoperatively.
Face to face adherence reminder session will take place to stress the post-operative instructions at the following time intervals:
Radiographs:
Radiographic ridge width change (primary outcome), buccal ridge height (BRH), and lingual ridge height (LRH) (secondary outcomes) will be assessed by an independent examiner (RW) on CBCT scans obtained at baseline and 3 months postoperatively.
Histological analysis:
For both groups (test and control), before the implant insertion, the grafted site is to be exposed and biopsies from all sites will be excised using a trephine cylindrical drill graduated to indicate the depth (from 5 to 18 mm) with abundant irrigation using sterile saline. Immediate preservation of biopsies in a 10% formalin solution, and then sent for histologic analysis to be analyzed.
Justification for Selecting Radiographic Ridge Width as the Primary Outcome and Excluding Implant-Related Confounders.
This study uses a 3-month post-extraction evaluation point to accurately capture the direct biological effect of socket preservation prior to any implant-related remodeling.
The decision to shorten follow-up duration from 6 months to 3 months is supported by:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alveolar ridge preservation using vitamin C with dentin graft and i-PRF | Experimental | Pure vitamin C will be added and extraction socket will be filled with the corresponding graft material. 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. |
|
| Alveolar ridge preservation using autogenous demineralized denting graft combined with i-PRF. | Active Comparator | Autogenous demineralized dentin graft combined with i-PRF and extraction socket will be filled with the corresponding graft material. This mix provided promising clinical outcomes and considered an ideal bioactive graft material for hard tissue regeneration. Autogenous particulate dentin and platelet rich fibrin mix assist healing and counteract pronounced resorption of alveolar process.It can be used as an excellent autogenous graft material to replace other autogenous graft materials, 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alveolar ridge preservation using autogenous demineralized dentin graft and i-PRF | Procedure | Flapless 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noha A Barwa, Bachelor | Contact | +201116010759 | noha.ahmed@dentistry.cu.edu.eg | |
| Nesma Shemais, Lecturer | Contact | nesma.shemais@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Karim fawzy, Professor | Cairo University | Study Director |
| Nesma Shemais, Lecturer | Cairo University | Study Chair |
| Noha Barwa, Bachelor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Recruiting | Cairo | Egypt |
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A randomized clinical trial
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double blinded
|
| Alveolar ridge preservation using vitamin C with dentin graft and i-PRF | Procedure | Flapless 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. |
|
| 3 months |
| 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). | 3 months |
| 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 3 months postoperatively. |
| 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. | after 3 months postoperatively. |
| postoperative pain | Visual analogue scale (0-10) 10 is the worst pain | 2 weeks, 1 month and 3 months |
| Cairo University |
| Principal Investigator |
| ID | Term |
|---|---|
| C043309 | proliferation regulatory factors, human urine |
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