Evaluation of a one-piece ceramic implant used for single tooth replacement and three-unit bridge restoration. A cohort clinical trial

Not Applicable

• Conditions: K08.1; Loss of teeth due to accident, extraction or local periodontal disease

• Registration Number: DRKS00000226
• Lead Sponsor: Zentrum für ZahnmedizinKlinik für Kronen- und Brückenprothetik, Teilprothetik und zahnärztliche Materialkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-01
• Study Completion: 2017-04-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Ability to understand the nature of the study and the study related procedures.
2. Written informed consent obtained according to international guidelines and local law.
3. The subjects must be in the age of 18 to 70 years old.
4. The subject must be systemically healthy and have good compliance.
5. The subject must be in need of an implant supported partial denture or implant supported single tooth restorations.
6. The subjects must have sufficient bone volume and density i.e. an osseous architecture in the implant placement region enough to receive implants of 4.0 mm in diameter and a sufficient amount of bone for placing implants with a length of at least 8 mm.
7. The osseous architecture must be such that it is possible to obtain primary implant stability, i.e. final tightening torque of 35-45 Ncm.
8. The subject must have a stable occlusal relationship with no pronounced bruxism.
9. The implant sites must be free from infection and/or extraction remnants

Exclusion Criteria

1. Alcohol or drug abuse as noted in patient records or in patient history.
2. Smoking
3. Health conditions, which do not permit the surgical procedure (see section D5).
4. Reason to believe that the treatment might have a negative effect on the subject?s total situation (psychiatric problems), as noted in patient records or in patient history.
5. The patient has infectious disease, heart disease or disease of the circulatory system, metabolic disease, bone metabolism disorders, disturbance of the hematopoetic system, hematological disorders, wound healing disturbances, disorders of the endocrine system (i.e., uncontrolled diabetes), local (i.e., tumors, ulcers etc) or other contraindications for dental surgery as noted in patient records or in patient history. A female participant is pregnant.
6. The subject is not able to give her/his informed consent to participate.
7. The need of bone augmentation (e.g. sinus augmentation procedure) before implant installation to obtain a prosthetically correct implantation transversally. However, a minor augmentation procedure to cover exposed threads or interproximal/buccal grafting due to deficient sites is not an exclusion criteria.
8. Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation.
9. Severe bruxism or other destructive habits.
10. Immediate insertion (e.g. placement of the implant immediately after extraction)
11. Intake of medication that is known to interfere with the objectives of the study and/or are contraindications of the surgical procedure within 2 weeks prior to entry into the study.
12. Intake of investigational drugs less than 30 days prior to entry into the study
13. Female patients who are pregnant or breast feeding, or female adults of reproductive potential not employing an effective method of birth control (postmenopausal state at least since 2 years, surgically sterile, hysterectomy, or effective contraceptive method until placement of the final prosthetic restoration [condoms for women, diaphragm or contraceptive sponges, intrauterine device, hormonal contraception]).
In female adults of reproductive potential, implantation will only be performed if a negative urine pregnancy test result dated 3 to 14 days prior to implantation is documented. Women have to be advised that they must not become pregnant until placement of the final prosthetic restoration.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to evaluate the mean marginal bone resorption after 1, 3, and 5 years. The mean marginal bone resorption will be evaluated by central blind review of standardized digital/analogue periapical radiographs. The distance from the implant shoulder to the first radiographic observable bone-to-implant<br>contact at implant insertion (mean of mesial and distal measurements) will be subtracted from the distance from the implant shoulder to the first radiographic observable bone-to-implant contact after 1, 3, and 5 years, respectively.

Secondary Outcome Measures

Name	Time	Method
The secondary objectives are<br>1. the evaluation of the safety, success, and failure of the implantation and implant<br>over 10 years;<br>2. safety of the implantation and implant by means of the assessment of adverse<br>events and serious adverse events within 10 years after implantation.