Comparison of the effect of different types of custom abutments on aesthetic and survival outcomes, and peri-implant tissue health - A randomised control trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Gingival health: which include peri implant pocket depth (PPD), bleeding on probing (BOP) and plaque index (PI)
研究概览
简要总结
Comparison of the effect of different types of custom abutments on aesthetic and survival outcomes, and peri-implant tissue health - a randomised control trial.
This study investigates the gingival health, marginal bone level, pink esthetic score and survival rate of prosthesis in 5 different groups with different types of implant abutments. The groups are Group PFT: Implants with prefabricated titanium implant abutments. Group MPA: Implants with milled PEEK custom abutment. Group ZHA: Implants with Zr hybrid custom abutment. Group PHA: Implants with PEEK hybrid custom abutment. Group DMLS: Implants with DMLS Co-Cr custom abutment. sample size of the study is 50 and the study period is 2 years.
The null hypothesis states that there is no significant difference in terms of aesthetic and survival outcomes, and peri-implant tissue health of Groups: MPA, ZHA, PHA and DMLS when compared to prefabricated titanium implant abutments (PHA).
The outcomes are assessed as follows
Gingival health: which include peri implant pocket depth (PPD), bleeding on probing (BOP) and plaque index (PI) at 1 week after final prosthesis insertion, 3 months and 6 months. Marginal bone levels immediately after final prosthesis insertion, 3 months and 6 months. Pink esthetic score (PES) during the final prosthesis delivery and at 3 months and 6 months. Survival rate of prosthesis after 3 months and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants of age
- •60 years regardless of the gender. 2.Patients with single or multiple missing teeth to be replaced by implant prosthesis. 3.Patients with good oral hygiene and without any uncontrolled periodontal disease. 4.Sufficient mesio-distal and apico-coronal space for implant prosthesis placement. 5.Patients having stable occlusion. 6.Systemically healthy participants without any history of periodontal disease and smoking.
排除标准
- •1.Patients developing systemic diseases during the study that would interfere with dental implant therapy.
- •2.Patients who are pregnant or becoming pregnant during the course of the study.
- •3.Patients failing to obtain osseointegration after implant placement.
结局指标
主要结局
1.Gingival health: which include peri implant pocket depth (PPD), bleeding on probing (BOP) and plaque index (PI)
时间窗: 1.Gingival health: which include peri implant pocket depth (PPD), bleeding on probing (BOP) and plaque index (PI) at 1 week after final prosthesis insertion, 3 months and 6 months. | 2.Marginal bone level: Immediately after final prosthesis insertion, 3 months and 6 months. | 3.Pink esthetic score (PES): during the final prosthesis delivery and at 3 months and 6 months. | 4.Survival rate of prosthesis: After 3 months and 6 months.
2.Marginal bone level
时间窗: 1.Gingival health: which include peri implant pocket depth (PPD), bleeding on probing (BOP) and plaque index (PI) at 1 week after final prosthesis insertion, 3 months and 6 months. | 2.Marginal bone level: Immediately after final prosthesis insertion, 3 months and 6 months. | 3.Pink esthetic score (PES): during the final prosthesis delivery and at 3 months and 6 months. | 4.Survival rate of prosthesis: After 3 months and 6 months.
3.Pink esthetic score (PES)
时间窗: 1.Gingival health: which include peri implant pocket depth (PPD), bleeding on probing (BOP) and plaque index (PI) at 1 week after final prosthesis insertion, 3 months and 6 months. | 2.Marginal bone level: Immediately after final prosthesis insertion, 3 months and 6 months. | 3.Pink esthetic score (PES): during the final prosthesis delivery and at 3 months and 6 months. | 4.Survival rate of prosthesis: After 3 months and 6 months.
4.Survival rate of prosthesis
时间窗: 1.Gingival health: which include peri implant pocket depth (PPD), bleeding on probing (BOP) and plaque index (PI) at 1 week after final prosthesis insertion, 3 months and 6 months. | 2.Marginal bone level: Immediately after final prosthesis insertion, 3 months and 6 months. | 3.Pink esthetic score (PES): during the final prosthesis delivery and at 3 months and 6 months. | 4.Survival rate of prosthesis: After 3 months and 6 months.
次要结局
未报告次要终点
研究者
Krishnaprasad A
Government Dental College, Kozhikode