Dimensional Changes of Peri-implant Tissue in Immediate Implants With Individualized Healing Abutments Using a CAD/CAM Technique: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Buccal-lingual/palatal soft tissue dimensional changes
研究概览
简要总结
The loss of a tooth leads to a series of biological changes in the tissues, resulting in bone resorption and gingival collapse. To avoid these problems, it has been proposed to place immediate post-extraction implants, allowing a reduction in treatment time and the number of surgeries, as well as better maintenance of the tissues. This technique can be performed with standard abutments after implant placement or, more recently, the use of temporary abutments has been proposed.
详细描述
Objective
To check if custom healing abutments manufactured using CAD/CAM technique in immediate implants promote greater dimensional stability of the peri-implant tissue compared to standard healing abutments.
Methods: After the extraction, an immediate Klockner Vega+ implant will be placed and the gap will be filled with a bone substitute (Cerabone, Botiss). The patient will then be randomized to the control group (standard healing abutment) or the test group (custom healing abutment using CAD/CAM technique). In the latter case, a peripheral seal is achieved, allowing for wound closure and stabilization of the clot with the same shape as the crown in its transmucosal part.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patient ( 25 years old).
- •Need for extraction of an irrational tooth to be treated in the molar/premolar position of the upper/lower arch.
- •Presence of 2mm of keratinized gingiva.
- •Bone dehiscence in the alveolar walls of 2 mm. 2 mm.
- •Adequate amount of bone in the interradicular septum to stabilize the implant (minimum height 10 mm, minimum width 4 mm at the base of the septum).
- •Plaque index (FMSPI, full mouth score plaque index) < 10%.
- •Non-smokers or smokers of less than 10 cigarettes per day.
- •Absence of systemic diseases that contraindicate implant surgery.
排除标准
- •Presence of alveoli with dehiscence >2mm.
- •Presence of adjacent implants.
- •< 2mm of keratinized gingiva.
- •Presence of active infection (fistula, suppuration) at the extraction site.
- •Presence of apical granuloma >2mm in diameter in the root(s) of the tooth or teeth to be extracted.
- •Residual bone apical to the extraction insufficient to anchor the implant.
- •Pregnant or lactating women.
- •Severe cognitive or psychiatric disorders.
- •Compromised general health status ( ASA IV).
- •Use of drugs that alter bone metabolism and healing.
- •Absence of manual primary stability of the implant
- •Bone dehiscence or fenestration after implant placement (manual rotation).
- •Gap 2mm between the implant and the vestibular bone wall.
研究组 & 干预措施
Control group
Will receive standard healing abutments
干预措施: Standard healing abutment (Device)
Individualized healing abutment group
Will receive individualized healing abutments
干预措施: Individualized healing abutment (Device)
结局指标
主要结局
Buccal-lingual/palatal soft tissue dimensional changes
时间窗: 12 months
They will be evaluated after superimposing the initial STL files with the follow-up ones. In addition, photos, periapical radiographs and a new intraoral scan at 3 months, 6 months and 1 year will be taken. In a 2D buccal-lingual slice corresponding to the center of the ridge, measure at the vestibular and palatal level from the point of maximum preoperative STL soft tissue contour (mucosal margin and at 3 mm and 5 mm apical to the margin).
次要结局
- Vestibulo-lingual/palatal dimensional changes of the alveolar bone (CBCT)(12 months)
- Thickness of vestibular and lingual/palatal cortex (CBCT)(12 months)
- Dehiscence of peri-implant vestibular and lingual/palatal mucosa:(12 months)
- Horizontal remodeling of vestibular and lingual/palatal cortex (CBCT)(12 months)
- Vertical changes of the vestibular and lingual/palatine cortex (CBCT)(12 months)
- Bleeding/Suppuration on probing(12 months)
- Marginal bone level (periapical x-ray)(12 months)
- Probing pocket depth(12 months)
- Implant survival(12 months)
- Patient-reported variables (satisfaction, pain)(12 months)