Prospective clinical multicenter observation study on immediate implantation and immediate loading protocols in the digital workflow in single tooth implants in the anterior region of the jaw
- Conditions
- K08Other disorders of teeth and supporting structures
- Registration Number
- DRKS00022273
- Lead Sponsor
- Poliklinik für Zahnärztliche Prothetik, Propädeutik und Werkstoffwissenschaften der Universität Bonn; Universitätsklinikum Bonn ÄoR Zentrum für Zahn-, Mund- und Kieferheilkunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Written documented declaration of consent and consent to participate in the study; Patients who are able to follow the study instructions and who are likely to comply with all required study visits. (Compliance); There is sufficient bone available for implantation; At least one tooth with the indication for extraction and immediate implantation or a single tooth gap with the indication for implantation; Periodontal healthy dentition not in need of therapy; Good oral hygiene (plaque index <30%); Exclusion of parafunctions; Systemically healthy
Patients younger than 18 years or older than 90 years; Patient does not consent to study;
The patient is unable to understand the scope, meaning, and consequences of this clinical trial; Inability of the patient to follow the course of the study; Simultaneous participation in another clinical trial or participation in a clinical trial taking an investigational medicinal product up to 30 days before participating in this clinical trial; Known or ongoing abuse of medication, drugs or alcohol; Current or planned pregnancy or breastfeeding; Medications that affect bone metabolism (e.g. bisphosphonates, corticosteroids; untreated / poorly controlled diabetes mellitus (HbA1c> 7);
Radiation in the head and neck area; Crohn's disease; Immune deficiency, which massively restricts regular wound healing; Oral mucosal diseases in the operating area (e.g. thrush, leukoplakia, etc.);Insufficient amount of bone: horizontal width: at least 7 mm, vertical height: at least 10 mm
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of the target implant position with the actual position of the implant after navigated insertion (approximal fit of the provisional restoration made according to digital planning)
- Secondary Outcome Measures
Name Time Method Determination of torque during implant insertion, determination of the implant stability quotient (ISQ) value by means of resonance frequency measurement, implant healing (wound control, X-ray), soft tissue changes (periodontal status, photo documentation, measurement of the papilla height, digital impression using an intraoral scanner)