Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- papilla fill index
研究概览
简要总结
Regenerating a predictable inter-implant papilla is the most complex and challenging aspect of implant dentistry. The aim of the study was to compare the efficacy of I shaped incision technique and conventional midcrestal incision technique for interimplant papilla reconstruction in a 6 month clinical trial.
详细描述
A total of 40 implants were placed in 12 patients. Groups were determined at second stage surgery, I shape technique used in test group and mid-crestal technique used in control group. The clinical parameters, including modified plaque index, modified sulcus bleeding index, probing depth, keratinized tissue level were recorded baseline, 3 and 6 month. The vertical distance between the crests top-contact point was evaluated with digital periapical radiographs at baseline 3 and 6 month. Also the clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images. With these images the ratio of the papilla area in proportion to the embrasure area and the papilla classification was measured. Non-parametric test were used for statistically analysis.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No sistemic condition, and age > 18 years,
- •healthy soft tissue (bleeding on probing (BOP) ≤ 20%, Plaque Index ≤ 15%,
- •in a need of at least two collateral implants in the maxilla from second premolar to second premolar
- •sufficient keratinized tissue
- •no bone augmentation procedures before implant placement
- •use of tobacco 10N ≥ cigarettes daily
- •sufficient distance between opposite occluding dentition at the proposed implant sites
排除标准
- •history of aggressive periodontitis,
- •systemic diseases such as diabetes
- •pregnant or lactating women
- •radiation therapy in the head and neck area wihtin the previous 12 months,
- •heavy smokers
研究组 & 干预措施
Test group- ı shape incision
Second stage surgery was made I shape incision technique .
干预措施: papilla fill index (Other)
Test group- ı shape incision
Second stage surgery was made I shape incision technique .
干预措施: crestal bone loss (Other)
Test group- ı shape incision
Second stage surgery was made I shape incision technique .
干预措施: probing depth (Other)
Test group- ı shape incision
Second stage surgery was made I shape incision technique .
干预措施: Modified sulcus bleeding index (Other)
Test group- ı shape incision
Second stage surgery was made I shape incision technique .
干预措施: Modified plaque index (Other)
Control group- midcrestal incision
In the control group second stage surgery was made using the conventional method, midcrestal technique.
干预措施: papilla fill index (Other)
Control group- midcrestal incision
In the control group second stage surgery was made using the conventional method, midcrestal technique.
干预措施: crestal bone loss (Other)
Control group- midcrestal incision
In the control group second stage surgery was made using the conventional method, midcrestal technique.
干预措施: probing depth (Other)
Control group- midcrestal incision
In the control group second stage surgery was made using the conventional method, midcrestal technique.
干预措施: Modified sulcus bleeding index (Other)
Control group- midcrestal incision
In the control group second stage surgery was made using the conventional method, midcrestal technique.
干预措施: Modified plaque index (Other)
结局指标
主要结局
papilla fill index
时间窗: 6 month
Papilla fill index will be recorded 6th month after baseline
crestal bone loss
时间窗: Change from baseline crestal bone level up to 6 months
Crestal bone loss was measured on radiographs between baseline-6th month.
vertical distance
时间窗: baseline, 3 and 6 month
Inter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs.
papilla fill index
时间窗: baseline
Baseline will be 1 week after cementation of the crowns.
papilla fill index
时间窗: 3 month
Papilla fill index will be recorded 3rd month after baseline
crestal bone loss
时间窗: Change from baseline crestal bone level up to 3 months
Crestal bone loss was measured on radiographs between baseline-3rd month.
次要结局
- Modified sulcus bleeding index(Modified sulcus bleeding index was recorded at 6 month)
- Modified plaque index(Modified plaque index was recorded at 6 month)
- Keratinized tissue level(Keratinized tissue level was recorded at 6 month)
- Probing depth(6 month)
- Probing depth(baseline)
- Probing depth(3 month)
- Modified sulcus bleeding index(Modified sulcus bleeding index was recorded at baseline)
- Modified sulcus bleeding index(Modified sulcus bleeding index was recorded at 3 month)
- Modified plaque index(Modified plaque index was recorded at baseline)
- Modified plaque index(Modified plaque index was recorded at 3 month)
- Keratinized tissue level(Keratinized tissue level was recorded at baseline)
- Keratinized tissue level(Keratinized tissue level was recorded at 3 month)
研究者
Özge PEHLİVANOĞLU
Özge PEHLİVANOĞLU, PhD,DDS Ege University, School of Dentistry
Ege University