Split Mouth Clinical Study to Compare the Secondary Stability of Dental Implants Using Immediate Gradual Loading Versus Early Loading Protocol in Posterior Maxilla. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- secondary stability of dental implant (ISQ Osstell Mentol)
研究概览
简要总结
The aim of this split mouth study is to compare which method is better in reducing bone loss and healing times following implants. Specifically, the two methods investigated will be immediate gradual loading and early loading protocol.
Research Hypothesis Immediate gradual loading using gingival formers is superior to early loading protocols in improving bone quality and thus reducing the healing time.
详细描述
These two methods (gradual loading and early loading) will both be used in implants patients with the aim to compare which protocol leads to a better outcome for the patient.
A 'better outcome' is defined as the method, which leads to the least crestal bone loss, and the fastest healing time.
Immediate gradually loaded side: will include transmucosal healing of dental implants using gingival formers which will be replaced every 2 weeks by consequent larger size gingival former.i.e. at surgery time the implants will receive 2 mm height gingival former which will be swapped by 3 mm, 4 mm, 5 mm and the last is 6 mm
early loaded side: implants will be submerged from the surgery time till loading time (2 month).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with bilateral Partial or complete edentulous areas in maxillary premolar/molar region.
- •Free medical history.
- •Enough bone quantity.
- •Enough keratinized mucosa
排除标准
- •Systemic disease.
- •Irradiated bone (radiotherapy).
- •Heavy smoking habit.
- •Patients undergoing long-term immunosuppressive therapy.
- •Atrophic ridges.
- •Presence of any local bony lesion.
- •Presence of mandibular parafunctional habits
研究组 & 干预措施
implant A
will include implants with immediate progressive loading using gingival formers of different sizes
干预措施: immediate progressive loading using gingival formers (Procedure)
implant B
The implants will remain submerged from surgery time till loading time 2 month.(submerged healing)
干预措施: submerged healing (Procedure)
结局指标
主要结局
secondary stability of dental implant (ISQ Osstell Mentol)
时间窗: 2 month
ISQ Osstell Mentol
次要结局
- Bone loss using Periapical Radiographic (Long Cone Paralleling technique)(2 month)
研究者
Elhassan Mohamed Elsayed Mostafa Mossad
Master student
Cairo University