Submerged Vs Non-Submerged Guided Bone Regeneration Simultaneous to Implant Placement.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Vertical bone dimensional changes
研究概览
简要总结
Dental implants are worldwide recognized one of the best manners to replace lost or hopeless prognosis teeth. There are different variables that creates proper conditions for long-term prognosis of implant treatments.
Implant position and surrounding bone around them, have been described in scientific literature to be key factors in the longevity of those treatments.
It has to be defined the "critical bone thickness" around implants. It basically means that implants has to be completely surrounded by bone, that will serve as protection. If the implants are not surrounded by bone, procedures as guided bone regeneration may be performed.
Those procedures can be executed before or simultaneously during the implant placement. In the standard procedure, the simultaneous guided bone regeneration during implant placement requires to leave the implant and the regeneration healing below the gingiva, needing a second surgery for accesing to those implants.
In this randomized controlled trial the hypothesis is to discover if not submerging this regenerations may show the same results than submerged ones.
For that, the objective is to study the different variables around these regeneration to evaluate the performance of non-submerged protocol.
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, Outcomes Assessor)
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
- •• Men and women over 18 years old.
- •Patients requiring single-unit implant restoration in any tooth site of the maxilla and mandible in between teeth.
- •Anticipation of a peri-implant buccal osseous dehiscence by means of a CT imaging (cone-beam computed tomography, CBCT) with a maximum vertical dimension height (VDH) of 50%.
- •Presence of adjacent teeth.
- •Presence of antagonist teeth.
- •Minimum primary stability of 25Ncm.
- •Non-smokers or light smokers (< 10 cigarettes per day).
- •Absence of systemic diseases that could influence the outcome of the therapy (i.e., uncontrolled diabetes mellitus, osteoporosis, biphosphonate medication).
- •Tooth extraction performed at least 4 months before implant placement.
- •Good level of oral hygiene (Plaque Index < 25%) (Löe, 1967)
- •Written informed consent signed.
- •Keratinized mucosa of at least 2mm on the buccal and lingual of the implant.
排除标准
- •Implant surgery requiring sinus lift procedure.
- •Previous bone augmentation at the implant site.
- •Active periodontal disease.
- •Acute infection at the rehabilitation site.
- •Long-term non-steroidal anti-inflammatory drug therapy (3 months).
- •Lactating females or currently pregnancy.
- •Severe cognitive or psychiatric disorders.
- •Unwillingness to return for follow-up examination.
研究组 & 干预措施
Control Group (Submerged Approach)
Standard/Conventional approach in which guided bone regeneration simultaneous to implant placement is leaved submerged under gingival tissue by suturing looking for first intention healing.
干预措施: Guided Bone Regeneration (Submerged) (Procedure)
Test Group (Non-Submerged Approach)
To test approach in which guided bone regeneration simultaneous to implant placement is leaved in a non-submerged manner with second intention healing around an abutment and interproximal suturing.
干预措施: Guided Bone Regeneration (Non-submerged) (Procedure)
结局指标
主要结局
Vertical bone dimensional changes
时间窗: 0-12months
Comparison between CBCT images. Vertical bone changes in mm from initial CBCT to 12 months CBCT will be asessed.
次要结局
- Horizontal bone dimensional changes(0-12 months)
- Buccal Bone thickness (Dehiscence resolution)(0-12 months)
- Marginal Bone Loss (MBL)(0-12 months)
- Peri-implant clinical parameters(0-12 months)
- Volumetric parameters(0-12 months)
- PROMs(0-12 months)
研究者
Germán E. Pardo Perl
DDS, MSc, PhD (Cand)
Universitat Internacional de Catalunya