Comparative evaluation of Soft tissue changes, pink esthetic scores, marginal bone level and patient reported outcomes on adjunctive use of A-PRF and frozen A-PRF in delayed implant placement – A randomized clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- 1 Papillary height
研究概览
简要总结
The study is to evaluate and compare the pink esthetic scores, peri implant soft tissue changes, marginal bone level ,wound healing, patient satsification and implant stability by adjunctive use of A-PRF and Frozen A-PRF and a total of 27 subjects with mandibular partial edentulous area will be recruited from out patient department of periodontics and implantology and will be assigned into 3 groups of 9 in each where in control group conventional implant placement and approximations of flaps using sutures will be done .In test group 1 conventional implant placement with A-PRF membrane will be placed and approximations of flaps using sutures will be done.In test group 2 conventional implant placement with Frozen A-PRF membrane will be placed and approximations of flaps using sutures will be done and in all the three groups Pink Esthetic Score at baseline,1month,3 months ,papillary height, thickness of peri implant mucosa ,width of peri implant mucosa ,peri implant marginal bone loss at baseline,3 months,6months ,implant stability at base line 3 months and wound healing at 14 days,1 month,3 months and patient satisfication questionnaire are evaluated .The data will be analyzed individually for all the patients.There is no conflict of intreset
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 68.00 Year(s)（—）
- 性别
- All
入选标准
- •1 FMPS, FMBS less than 20% 2 D2,D3 bone 3 Patients requiring implant in mandibular posterior region.
排除标准
- •1 Patients with platelet disorders (thrombocythemia, thrombocytopenia) 2 Patients under anti- coagulants3 3 Patients with uncontrolled systemic diseases 4 Patients with para functional habits 5 Pregnant and lactating women 6 Patients under chemotherapy.
结局指标
主要结局
1 Papillary height
时间窗: 1 Papillary height and thickness of peri-implant mucosa at baseline,1 month 3 month | 3 Width of peri-implant mucosa at baseline,3months,6months | 4 Peri implant marginal bone loss at baseline 3months 6 months
2 thickness of peri-implant mucosa
时间窗: 1 Papillary height and thickness of peri-implant mucosa at baseline,1 month 3 month | 3 Width of peri-implant mucosa at baseline,3months,6months | 4 Peri implant marginal bone loss at baseline 3months 6 months
3 Width of peri-implant mucosa
时间窗: 1 Papillary height and thickness of peri-implant mucosa at baseline,1 month 3 month | 3 Width of peri-implant mucosa at baseline,3months,6months | 4 Peri implant marginal bone loss at baseline 3months 6 months
4 Peri implant marginal bone loss
时间窗: 1 Papillary height and thickness of peri-implant mucosa at baseline,1 month 3 month | 3 Width of peri-implant mucosa at baseline,3months,6months | 4 Peri implant marginal bone loss at baseline 3months 6 months
次要结局
- 1 Implant stability(2 pink esthetic scores)
研究者
Dr Arimanda Prithvi
Vishnu Dental College