Narrow Diameter Implants Versus Standard Diameter Implants With Simultaneous Bone Regeneration For The Treatment Of Atrophic Posterior Area
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Marginal bone level difference
研究概览
简要总结
NDI represent an advisable treatment option when the mesio-distal space is compromised. In a recent retrospective study with a follow-up of 8 years in which they wanted to evaluate the long-term survival, complications, peri-implant conditions, marginal bone loss, and patient satisfaction of fixed dental prostheses supported by NDI in the posterior area. They observe a survival rate of 97% and absence of prosthetic complications after the study period time. More recently, Souza et al. performed a prospective randomized split mouth study with 3 years follow-up with the aim of comparing marginal bone level, implant survival and success rates and prosthesis success rates of NDI and SDI placed in the posterior area of the mandible to support single prosthesis. They observed an implant survival rate of 100% for both groups at 1 and 3 years. The prosthesis success rate at 1 and 3 years was of 95.4% and 100%, respectively.
NDI present a high survival rate on the evaluated studies. Therefore, the aim of the first study is to compare the patient related outcomes, implants and prostheses success and survival rates of pure titanium NDI versus SDI with simultaneous bone regeneration in narrow alveolar ridges at posterior areas of the maxilla and the mandible.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old
- •Healthy periodontal status (absence of generalized probing pocket depth (PPD) <4mm)
- •Oral hygiene levels (FMPS <20 and FMBS <20)
- •Ridge width of >5mm and <6.5mm and minimum bone height of 10mm prior evaluation on a CBCT scan
- •Presence of antagonistic natural tooth or fixed prosthetic restoration
- •Presence of adjacent teeth
- •One maxillary or mandibular premolars
- •Minimum of 3mm of keratinized tissue over the bone crest (20)
- •Bone regeneration within the limits of the prosthetic restoration.
- •Unitary prosthesis
- •Screwed retained restorations
排除标准
- •Presence of active chronic or aggressive periodontal disease
- •Presence of systemic disease which contraindicate surgery (patients with an ASA ≥ 3)
- •Drugs or medications which may alter the results (chronic intake of analgesic medication)
- •Smokers (>10cig/day)
- •Pregnant women
- •History of head and neck radiotherapy.
- •Anterior area (from 1.3 to 2.3 and from 3.3 to 4.3) and molar area
- •Previous guided bone regeneration
- •Location where there is not sufficient restorative space (mesio-distally <8mm for every restoration unit and <5mm from the bone crest to the antagonist)
- •Implant dehiscence of more than 2/3 of the implant.
- •Implants which cannot be restored with a screwed restoration
- •Implants which doesn't reach a manual implant stability
- •implants which after placement doesn't reach a favourable position according to the restoration.
研究组 & 干预措施
Control group
干预措施: Test group (Procedure)
Control group
干预措施: Control group (Procedure)
Test Group
干预措施: Test group (Procedure)
Test Group
干预措施: Control group (Procedure)
结局指标
主要结局
Marginal bone level difference
时间窗: The changes in MBL will be registered at 8 weeks, 6 months, 12 months, and 3 years.
To assess the MBL, each radiograph must register the most coronal aspect of the bone crest (BC) at mesial and distal to the implant, the position of the implant shoulder (IS) and the first bone to implant contact (FBiC). The marginal bone crest level (MBL) will be measured by calculating the distance between BC and IS. MBL will be considered negative when position of BC is coronal to IS, positive when position BC is apical to IS.
次要结局
- Implant survival criteria:(12 months)
- Level of keratinized tissue surrounding the implants(12 months)
- Resonance frequency analysis(Implant surgery and after 12 months)
- Peri-implant mucosal thickness using a millimetre probe(12 months)
- Prosthesis success criteria(12 months)
- Implant success criteria:(12 months)
- Presence of peri-implant health(At 12 weeks, 6 and 12 months)
- Presence of post-surgical complications(At 1, 2 and 12 weeks)
- Presence of prosthetic complications(At 6 and 12 months)
- Patient related outcomes(At 1, 2 and 12 weeks)
- Patient Related Outcomes(At 7 days)
- Patient Related Outcomes(At 1, 2 and 12 weeks)
研究者
Rodrigo González Terrats
Doctor Dental Surgery
Universitat Internacional de Catalunya