Evaluation of Dentin Graft and I-PRF With and Without Vitamin C for Post-extraction Socket Preservation
- Conditions
- Socket Preservation
- Interventions
- Procedure: Alveolar ridge preservation using vitamin C with dentin graft and i-PRFProcedure: Alveolar ridge preservation using autogenous demineralized dentin graft and i-PRF
- Registration Number
- NCT06569264
- Lead Sponsor
- Cairo University
- Brief 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.
- Detailed Description
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 and marginal bone loss, 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:
* ≥ 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.
* Requiring alveolar preservation after tooth extraction prior to placement of dental implant.
* Participants that are eligible for immediate implantation, yet having factors that are hindering these patients from immediate placement of an implant at the time of extraction (ex: Financial related factors - psychological psychological factors - time related factors).
* Cooperative patients who are willing to commit for 6 months follow up.
II. Exclusion criteria:
* Pregnant female.
* Acute infection at extraction site.
* Systemic conditions affecting healing (e.g., diabetes, medications as bisphosphonates...)
* A participant who had radiotherapy or chemotherapy.
* Psychiatric patient, or with a learning disability, or unable to give consent.
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.
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.
In the intervention group 25mM of pure vitamin C will be added to the fresh blood, and the tube will be centrifuged at around 700 RPM for 3 minutes.
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:
1. Follow the instructions completely.
2. Keep up a strict follow-up schedule.
3. Not to touch the surgical area, with the tongue or fingers.
4. Do not wear any kind of dental appliances, on or around the surgical site.
The sutures will be removed two weeks after the surgery. On the first day postoperatively, a baseline cone-beam computed tomography (CBCT) scan will be conducted. A final follow-up visit and CBCT scan will be scheduled for six months postoperatively.
Face to face adherence reminder session will take place to stress the post-operative instructions at the following time intervals:
* 3 days and 7 days post-operatively, for clinical assessment of swelling, wound dehiscence, and other adverse events.
* 2 weeks after the operation for follow up.
* Lastly, 6 months before implant placement.
Radiographs:
Radiographic alveolar bone changes of marginal bone loss (primary outcome), buccolingual ridge width (BLRW), 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 6 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
Inclusion criteria:
- ≥ 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.
- Requiring alveolar preservation after tooth extraction prior to placement of dental implant.
- Participants that are eligible for immediate implantation, yet having factors that are hindering these patients from immediate placement of an implant at the time of extraction (ex: Financial related factors - psychological psychological factors - time related factors).
- Cooperative patients who are willing to commit for 6 months follow up.
- Pregnant female.
- Acute infection at extraction site.
- Systemic conditions affecting healing (e.g., diabetes, medications as bisphosphonates...)
- A participant who had radiotherapy or chemotherapy.
- Psychiatric patient, or with a learning disability, or unable to give consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alveolar ridge preservation using vitamin C with dentin graft and i-PRF Alveolar ridge preservation using vitamin C with dentin graft and i-PRF Pure vitamin C will be added to the fresh blood, and the tube will be centrifuged at around 700 RPM for 3 minutes and extraction socket will be filled with the corresponding graft material and dentin graft. 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. Alveolar ridge preservation using autogenous demineralized dentin graft and i-PRF 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.
- Primary Outcome Measures
Name Time Method Marginal bone level after 6 months postoperatively. 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
- Secondary Outcome Measures
Name Time Method Patient reported outcomes baseline, 2 weeks, 1 month and 6 months postoperatively. absence of pain under vertical or horizontal forces using a visual analog scale (0-10).
Buccolingual ridge width after 6 months postoperatively. 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
Buccal and lingual ridge height after 6 months postoperatively. 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).
Histological evaluation of residual graft in human biopsies after 6 months postoperatively. 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.
Percentage of newly formed bone after 6 months postoperatively. 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.
Trial Locations
- Locations (1)
Faculty of Dentistry, Cairo University
🇪🇬Cairo, Egypt