Width of Keratinazed Mucosa in Immediately Loaded Posterior Implant Restorations Treated With Different Surgical Approaches: Randomized Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Widht of Keratinized mucosa
研究概览
简要总结
The present study will evaluate the difference in terms of keratinazed mucosa (KM) in computer guided implant placement with immediate loading, comparing a flapless approach to flap surgery with connective tissue graft.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
surgical treatment will be conducted with surgeon-investigator and patient unblinded. the outcome assessor will be blinded as primary outcome measurements will be taken on a computer.
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
- •Patients with partial edentulism in the posterior region (4-7) upper or lower for at least 3 months
- •Patient whose tomographic examination shows adequate bone volumes for computer guided placement of a standard diameter implant (> 3.5 mm) without the need for bone regeneration procedures
- •Patients who have accepted informed consent and participation in the study
- •Patients who do not have
排除标准
- •Eclusion Criteria
- •Patients who refuse to co-operate
- •Systemic conditions of exclusion:
- •Medical conditions requiring prolonged use of steroids
- •Severe hemophilia
- •In therapy with intravenous bisphosphonates
- •History of white blood cell dysfunction or deficiency
- •History of head and neck radiotherapy or chemotherapy
- •History of kidney failure
- •Pregnant or breastfeeding patient
- •History of uncontrolled endocrine disorders
- •Physical handicaps that hinder proper oral hygiene
- •Use of experimental devices or drugs within 30 days prior to implant placement surgery
- •Alcoholism or drug abuse
- •Smokers of> 10 cigarettes per day or the equivalent cigar or> 10 tobacco-based chewings per day
- •Conditions or circumstances that prevent the completion of participation in the study or interfere with the analysis of the study results
- •Local exclusion conditions:
- •Local inflammation, including untreated periodontitis
- •Patients with erosive lichen planus
- •History of local radiation therapy
- •Presence of bone lesions
- •Unhealed extraction sites
- •History of bone reconstruction and bone grafting techniques in the sites where the implants are to be inserted
- •Bleeding index> 30% and number of pockets> 5mm greater than 10
研究组 & 干预措施
Connective tissue graft
patient in this group will be treated with a flap and a connective tissue graft at the moment of implant placement.
干预措施: Connective tissue graft (Procedure)
Flapess
patient in this group will be treated with a flapless approach at the moment of implant placement.
干预措施: Flapless (Procedure)
结局指标
主要结局
Widht of Keratinized mucosa
时间窗: 2-4-8-12-24 weeks - 1-2-3-4-5 years
variation of keratized mucosa from t0
次要结局
- Vas Scale(2 weeks)
- marginal bone loss(1-2-3-4-5 years)
- implant survival(1-2-3-4-5 years)
研究者
Stefano Storelli
Reasearcher
University of Milan