The Esthetic Outcome of Custom-Designed Profisionalisations of Immediate Implants in the Esthetic Zone: a Randomized, Controlled, Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- mid-facial recession (mm)
研究概览
简要总结
Fully digital immediate implant treatment by means of fully guided implant placement and custom designed provisionalisation with a individual designed abutment and temporary PMMA crown leads to better esthetic outcomes than free handed with regular provisionalisation on a temporary cylinder.
详细描述
Since many years dental implants serve as long-term predictable anchors for fixed and removable prostheses in fully and partially edentulous patients. A dental implant is a screw that is inserted into the jawbone to provide fixed support for a single crown, fixed partial/full denture or an overdenture. After local anaesthesia, the implant is inserted into a cavity that has been drilled into the jaw. New bone is allowed to grow around the implant for up to 3 till 6 months before a prosthetic device is attached.
Via a connecting element - 'abutment' - the crown, bridge or denture is attached to the dental implant. The abutment can be placed immediately after implant placement - 'one-stage surgery' - or during a second surgery - 'two-stage surgery'. In certain cases this abutment can already contain a provisional crown (a tooth).
Immediate implant placement and provisionalisation offers great benefits for the patient: one intervention, immediate tooth replacement, minimally invasiveness to name just a couple.
However, in recent years, there has been a debate in the scientific community on the long term esthetic outcome. This is important as this concept is predominantly used in high esthetic regions. Scientific evidence is frequently contradictory and confusing.
Digitalisation has found its way into implant dentistry. The combination of CBCT images and IO-scan images give the clinician and/or company the opportunity to plan the surgery in advance (even when the natural tooth is still in place). This might lead to 'guided' implant surgery (where the position of the implant is defined through a surgical guide) but also to custom-designed provisionalisation.
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
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •Males or females ASA I or II, between 25 to 80 years of age
- •One tooth in the high esthetic region planned for extraction.
- •Patient in good general health as documented by self-assessment.
- •Patients must be committed to the study and must be willing to sign the informed consent.
排除标准
- •Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- •Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- •Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- •Any systemic medical condition that could interfere with the surgical procedure or planned treatment.
- •Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.
- •Current pregnancy or breast feeding/ lactating at the time of recruitment.
- •Radiotherapy or Chemotherapy in head and neck area.
- •Intravenous and oral bisphosphonate therapy.
- •Unwillingness to return for the follow-up examination.
- •Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations.
- •Presence of osseous pathologies, that may interfere with normal wound healing.
- •Presence of oral lesions (such as ulceration, malignancy).
- •Local inflammation, including untreated periodontitis.
- •Patients with inadequate oral hygiene or unmotivated for adequate home care
结局指标
主要结局
mid-facial recession (mm)
时间窗: 6 months and 1 year after surgery
measurement CEJ to free gingival margin with periodontal probe
PES (pink esthetic score)
时间窗: 6 months and 1 year after surgery
assesses the soft tissue (gums); score 0-20
WES (white esthetic score
时间窗: 6 months and 1 year after surgery
Assesses the tooth itself in relation to the neigboring natural elements; score 0-20
次要结局
- buccal bone thickness(at implant surgery, 6 months and 1 year after surgery)
- Surgical time(during surgery)
- Implant success(6 months and 1 year after surgery)