Prospective clinical study to evaluate the clinical performance of immediately loaded PURE ceramic implants.A monocentric study
- Conditions
- tooth loss because of trauma, extraction or parodontitis.K08.1Loss of teeth due to accident, extraction or local periodontal disease
- Registration Number
- DRKS00018852
- Lead Sponsor
- Poliklinik für Zahnärztliche Chirurgie und Implantologie, ZZMK, Carolinum Zahnärztliches Universitäts-Institut gGmbH, Johann Wolfgang Goethe Universität Frankfurt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Being in need of at least one implant for the replacement of missing or non retainable teeth in the upper or lower jaw (in regions 16 to 26 or in the lower jaw in regions 36 to 46, excluding regions 12 and 22 as well as 32,31,42 and 41 FDI (narrow gaps), due to diameter limitations of the implant investigated)
- Adjacent teeth and/or implants have to be free of acute or chronical infections (e.g. periodontal or endodontic problems,peri-implantitis)
- Single tooth gaps (i.e. natural tooth roots or implants present on the sides adjacent to the implant)
- Opposing dentition must be natural teeth or fixed restoration
- Subject shall have a stable occlusal relationship
- Patient has been informed of the follow-up visits and is willing to return to the clinical center for these follow-up visits
- Subjects must have voluntarily signed the informed consent form before any study related action
- Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled 1. diabetes)
- Any contraindications for oral surgical procedures (according to instruction for use of implant system)
- Patients who smoke >10 cigarettes per day or cigar equivalents, or who chew Tobacco
- Bone metabolism disorders
- Uncontrolled para-functional diseases (bruxism, clenching or grinding of teeth)
- Disorders that impede the ability of patients to maintain adequate oral hygiene
- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
- Any patient with placed implant that cannot be immediately provisionalized or receive an individual healing abutment and need to be submerged healed
- Need of extended bone augmentation before or during implant placement
- Pregnant or breastfeeding women
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Implant success at final restoration and at each follow-up for up to 3 years post-surgery as evidenced by a standardized composite outcome, including following clinical parameters:<br>- Bleeding on Probing (BOP)<br>- Mucosal Recession (MR), <br>- Probing Pocket Depths (PD)<br>- Clinical Attachment Level (CAL)<br>Measured at: final restoration, at 6-month, 1-, 2- and 3- years post implant placement
- Secondary Outcome Measures
Name Time Method