No registrations found.
ID
Source
Brief title
Health condition
One missing or failing tooth being a molar in the maxilla or mandible;
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peri-implant bone level change
Secondary outcome
Clinical items and patient satisfaction
Background summary
Rationale: Nowadays, the use of dental implants for oral rehabilitation is a generally accepted treatment modality. During the first years of implant dentistry, dental implants were used mainly for the restoration of edentulous mandibles with implant-supported prostheses. Yet, there is a shift towards the application of dental implants for single-tooth replacements, supported by long-term studies reporting excellent survival rates (Den Hartog et al. 2008). Not only in the aesthetic region, but also in the posterior maxilla and mandible there is a growing interest in restoring function. Dental implants show a good performance in the posterior region (Telleman et al. 2011); in recent years attention has been shifted towards a better initial stability to reduce treatment time. Next to this, implants must be restored with crowns which are subject to minimal complications. Specially for the posterior region, companies have introduced the option of screw-retaining and zirconia as crown material, of which less technical complications are mentioned. The combination of posterior implants and screw-retained zirconia crowns are widely used, but prospective research on clinical performance and patient centered outcomes are lacking.
Objective: To evaluate the clinical performance of Astra Tech Implants EV and Atlantis CustomBase Abutments with full-contour zirconia Atlantis Crowns in the posterior maxilla and mandible.
Study design: A prospective case series.
Study population: a total of 50 participants.
Intervention: All patients will be treated with a Astra Tech Implant EV and an Atlantis CustomBase Abutments with full-contour zirconia Atlantis Crowns.
Main study parameters/endpoints: The main study parameters are: changes in marginal peri-implant bone loss and clinical performance. Additional parameters are: mucosal changes and patient satisfaction.
Study objective
Good clinical performance compared to literature
Study design
Tpre = before treatment: patient satisfaction
T1 = 1 month after restoration placement: radiographic bone level and clinical items
T12 = 12 months after restoration placement: radiographic bone level, clinical items and patient satisfaction
Intervention
All patients are treated with an Astra Tech Implant EV. After a period of 3 months a screw-retained zirconia restoration is placed.
Inclusion criteria
All patients referred to our department for single-tooth implant therapy in the maxillary and mandibular posterior region are considered for inclusion.
The following inclusion criteria are applied:
- one missing or failing tooth being a molar in the maxilla or mandible;
- enough bone to reach initial stability of the dental implant;
- at least 18 year of age;
- ASA score ≤ 2 (Smeets et al. 1998);
- adequate oral hygiene, i.e. Plaque Index Score (Silness and Loё, 1964) and Gingival Index
Score (Silness and Loё, 1964) ≤ 1;
- mesial-distal width of diastema at least 8 mm;
- patient is capable of understanding and giving informed consent.
Exclusion criteria
Exclusion criteria are:
- presence of active clinical periodontal disease as expressed by probing pockets depths ≥ 4 mm and bleeding on probing;
- presence of peri-apical lesions or any other abnormalities in the posterior region as determined on a radiograph;
- smoking;
- a history of radiotherapy to the head and neck region;
- use of intravenous bisphosphonates shorter than 10 years ago.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9059 |
| Other | METC UMCG : METc 2017-295 Non-WMO study |