Evaluation of Dentin Graft and I-PRF With and Without Vitamin C for Post-extraction Socket Preservation. A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Radiographic ridge width change
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
double blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Alveolar ridge preservation using vitamin C with dentin graft and i-PRF
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.
干预措施: Alveolar ridge preservation using vitamin C with dentin graft and i-PRF (Procedure)
Alveolar ridge preservation using autogenous demineralized denting graft combined with 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.
干预措施: Alveolar ridge preservation using autogenous demineralized dentin graft and i-PRF (Procedure)
结局指标
主要结局
Radiographic ridge width change
时间窗: 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
次要结局
- postoperative pain(2 weeks, 1 month and 3 months)
- Buccal ridge height(3 months)
- Lingual ridge height(3 months)
- Percentage of newly formed bone(after 3 months postoperatively.)
- Histological evaluation of residual graft in human biopsies(after 3 months postoperatively.)
研究者
Noha Ahmed Barwa
principle investigator Noha Barwa Master degree student, faculty of dentistry, Cairo University
Cairo University