Single Crown Supported by Short Implant Versus Standard Implant in Conjunction With Maxillary Sinus Floor Augmentation in the Posterior: a Randomized, Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 主要终点
- Oral health related quality of life as defined by oral health impact profile (OHIP-14).
研究概览
简要总结
Implant placement in the posterior part of the maxilla is frequently compromised due to atrophy of the alveolar process. Therefore, alveolar ridge augmentation is frequently necessary before or in conjunction with implant placement. The most commonly used method to augment the maxillary premolar and molar region involves the maxillary sinus floor augmentation (MSFA) with autogenous bone graft or a bone substitute. However, the use of autogenous bone grafts is associated with risk at the donor site morbidity and unpredictable graft resorption. Consequently, short implants are used increasingly to eliminate the need for bone augmentation. However, long-term studies comparing short implants and standard implants in conjunction with MSFA supporting single crown restoration in the posterior maxilla are missing. The primary outcome measures include survival of implant and suprastructures, peri-implant marginal bone level (MBL), professional evaluation of the suprastructure and soft tissue using pink esthetic score (PES) and white esthetic score (WES), patient satisfaction using visual analogue scale (VAS), and oral health related quality of life using oral health impact profile (OHIP-14) questionnaire. Secondary outcome measure include evaluation of the complication rate related to the two treatment modalities.
详细描述
The primary objective of the present study is to test the H0 hypothesis of:
- No differences in survival of suprastructures and implants with the two treatment modalities.
- No differences in peri-implant MBL, PES, WES, and patient satisfaction using VAS with the two treat modalities.
- No differences in oral health related quality of life using OHIP-14 with the two treatment modalities.
The secondary objective will include:
- Complications related to bone harvesting, implant installation, and MSFA.
The primary outcome measures included:
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>20 years
- •Partial edentulism in the posterior maxilla.
- •Height and weight of the maxillary alveolar process of at least 5.5 mm.
- •Mandibular occluding teeth.
排除标准
- •General contraindications to implant therapy.
- •Poor oral hygiene.
- •Progressive periodontitis.
- •Acute infection in the area intended for implant placement.
- •Parafunction, bruxism, or clenching.
- •Psychiatric problems or unrealistic expectations.
- •Heavy tobacco use, define as >10 cigarettes per day.
- •Pregnancy
结局指标
主要结局
Oral health related quality of life as defined by oral health impact profile (OHIP-14).
时间窗: 1-year follow up
Evaluation of oral health related quality of life using OHIP-14 questionnaire. OHIP-14 scale ranges from 0 to 56, with higher scores indicating poorer oral health impact profile.
Professional evaluation of the prosthetic restoration and soft tissue using pink esthetic score (PES) and white esthetic score (WES).
时间窗: 1-year follow up
Esthetic evaluation of suprastructure and soft tissue using PES and WES. PES includes 7 different variables: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue colour, and texture. Each variable is assessed with a 0, 1, or 2 score, with 0 being the poorest score and 2 the best according to the degree of match or mismatch compared with the anterior premolar or molar. The highest possible PES is 14. WES includes 5 different variables: Crown form, volume, colour, translucency, and texture. Each variable is assessed with a 0, 1, or 2 score, with 0 being the poorest score and 2 the best according to the degree of match or mismatch compared with the anterior premolar or molar. The highest possible WES is 10.
Survival of suprastructures.
时间窗: 1-year follow up
Survival of suprastructures is defined as absence of mechanical/or biological complications causing loss of suprastructures. Chipping of ceramics and loosening of the suprastructure were not categorized as loss of suprastructure.
Survival of implants.
时间窗: 1-year follow up
Survival of implants is defined as clinically stable and osseointegrated implants with absence of mobility, progressive marginal bone loss, and infection.
Radiographic MBL.
时间窗: 1-year follow up
Measurement of marginal bone level in millimeter.
Patient satisfaction.
时间窗: 1-year follow up
Evaluation of patient satisfaction using visual analogue scale (VAS). VAS with 0 indicating extreme dissatisfaction and 10 indicating complete satisfaction.
次要结局
- Complications.(1-year follow up)
研究者
Helle Baungaard Nielsen
Principal Investigator, PhD. Student, Department of Oral and Maxillofacial Surgery
Aalborg University Hospital