Esthetic outcomes of delayed implant placement in the anterior zone with customized and prefabricated gingival formers a Randomised control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- PINK AND WHITE ESTHETIC SCORE
研究概览
简要总结
- Participant Recruitment:
20 participants meeting the inclusion criteria will be recruited from a pool of patients seeking implant therapy.
- Group Assignment:
Continuous or sequential randomization will be used .Continuous or sequential randomization is a method used when participants are enrolled in a study over time rather than all at once. In this approach, as participants are recruited, they are randomly assigned to treatment groups. It ensures that each participant has an equal chance of being assigned to any treatment group at the time of enrollment.
Participants will be randomly assigned to either Study Group 1 (Customized Gingival Formers) or Study Group 2 (Prefabricated Gingival Formers).
10 patients in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor 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
- •Age more than 18yrs Single implant placement in the anterior esthetic zone (maxilla) Delayed extraction site with adequate bone volume Implants placed after a defined period of delayed extraction Healthy gingival tissue without severe periodontal disease Standardized photographic documentation Evaluation using esthetic assessment tools Informed consent and willingness to adhere to postoperative care.
排除标准
- •Smokers or heavy smokers Significant systemic diseases affecting healing or implant success Severe bone defects requiring extensive grafting Unrealistic esthetic expectations.
结局指标
主要结局
PINK AND WHITE ESTHETIC SCORE
时间窗: 4-5 months from the date of implant placement
次要结局
- Soft tissue changes & patient satisfaction(6 to 7 months from implant placement so basically 1 week after final prosthesis fabrication)