Evaluation of Dentin Graft and I-PRF With and Without Vitamin C for Post-extraction Socket Preservation. A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Radiographic ridge width change
Study Overview
Brief Summary
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.
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, 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 3 months follow up.
II. Exclusion criteria:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
double blinded
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 3 months follow up.
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.
Outcomes
Primary Outcomes
Radiographic ridge width change
Time Frame: 3 months
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(3 months)
- Lingual ridge height(3 months)
- postoperative pain(2 weeks, 1 month and 3 months)
- Percentage of newly formed bone(after 3 months postoperatively.)
- Histological evaluation of residual graft in human biopsies(after 3 months postoperatively.)
Investigators
Noha Ahmed Barwa
principle investigator Noha Barwa Master degree student, faculty of dentistry, Cairo University
Cairo University