Clinical and Radiographic Evaluation of Socket Shield Technique With or Without Flap Elevation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change from baseline marginal bone loss at 12 months
研究概览
简要总结
It is aimed to compare the bone changes and the amount of marginal bone loss after prosthetic loading around the immediately placed implants using the Socket Shield Technique with or without flap elevation.
详细描述
Temporary prostheses will be applied to patients in the flap and flapless surgery group 1 week after the surgical procedure, and permanent prostheses will be placed 3 months later. From this date, clinical controls will be made in the 1st, 3rd, 6th months and 1st year.
During these controls, biological complications (peri-implant mucositis, peri-implantitis), implant failure and survival rates, and complications related to the socket shield (socket shield exposure, infection) will be evaluated. Marginal bone loss around the implants and bone resorption in the horizontal and vertical directions will be compared between the two groups with cone beam computed tomography taken at the 1st year follow-up.
The Oral Health-Related Quality of Life Scale will be applied in the session where the temporary prosthesis is applied 1 week after the surgery, in the 1st month clinical control and in the 3rd and 6th month clinical control after the permanent prosthesis application, in order to evaluate the quality of life related to the surgical and prosthetic application of the patients in both groups, and comparisons between groups will be made.
In addition, intraoral photographs will be taken from the patients for aesthetic evaluation before the surgical procedure, at the 1st, 3rd and 6th month clinical control sessions. Pink Aesthetic Score (PES) and White Aesthetic Score (BES) will be evaluated on the photographs, and a comparison will be made between groups in terms of scores.
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
- None
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being systemically healthy (ASA classification I-II)
- •Being over 18 years old
- •Not smoking
- •Having good oral hygiene
- •Upper incisors and premolars that cannot be restored and have extraction indications
- •Periodontally healthy, non-mobile teeth
- •The amount and quality of bone suitable for immediate implant placement
排除标准
- •Periodontally unhealthy teeth
- •Teeth with vertical root fracture on the buccal surface
- •Teeth with a horizontal fracture below the bone level
- •Teeth with external and internal resorption affecting the buccal part of the root
- •Patients who are pregnant or suspected of pregnancy
研究组 & 干预措施
Flapless Surgery
干预措施: Immediate implantation with the Socket Shield Technique (Procedure)
Surgery With Flap Elevation
干预措施: Immediate implantation with the Socket Shield Technique (Procedure)
结局指标
主要结局
Change from baseline marginal bone loss at 12 months
时间窗: Baseline, 12th month
Measurement of marginal bone loss change between baseline and 12th month by cone beam computed tomography
次要结局
- Oral health impact profile questionnaire(Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month)
- Pink aesthetic score(Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month)
- White aesthetic score(Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month)
- Visual analog scale(Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month)
- Change of modified plaque index between baseline and follow-up periods(Baseline, 1st month, 3rd month, 6th month, 12th month)
- Change of modified bleeding index between baseline and follow-up periods(Baseline, 1st month, 3rd month, 6th month, 12th month)
- Change of peri-implant pocket depth between baseline and follow-up periods(Baseline, 1st month, 3rd month, 6th month, 12th month)
- Change in the width of keratinized mucosa between follow-up periods(Baseline, 1st month, 3rd month, 6th month, 12th month)
- Change in the mucosal recession between follow-up periods(Baseline, 1st month, 3rd month, 6th month, 12th month)
- Change in the mucosal thickness between follow-up periods(Baseline, 1st month, 3rd month, 6th month, 12th month)
研究者
Ezgi Gürbüz
Assist. Prof.
Kutahya Health Sciences University