Prospective clinical study to evaluate the success and survival of two-piece zirconia Hexalobe implants: A single center study
- Conditions
- K08.1Loss of teeth due to accident, extraction or local periodontal disease
- Registration Number
- DRKS00012469
- Lead Sponsor
- Charité Centrum Zahn-, Mund- und Kieferheilkunde, Zahnärztliche Prothetik, Alterszahnmedizin und Funktionslehre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Males and females with at least 18 years of age.
- Single tooth gaps at least 7.5 mm wide in maxilla or mandible (#1-#7 FDI) allowing the placement of a single implant. Adjacent mesial and distal tooth must be natural tooth.
- Adequate bone quality and quantity at the implant site to permit the insertion of a zirconia implant.
- Opposing dentition must be natural teeth or fixed restoration.
- If patient undergo a large bone augmentation (with autogenous bone block) a delay of 3.5 months must elapse before implantation.
- Patient has been informed of the follow-up visits and is willing to return to the clinical center for these follow-up visits.
- Free-end situations
- Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
- Patients who smoke >10 cigarettes per day or cigar equivalents, or who chew tobacco
- Cardiovascular disease
- Coagulation disorders (including taking anticoagulants)
- Metabolic bone disease
- Chemotherapy or radiation treatment
- Chronic inflammation
- Metabolic or systemic disorders associated with lesions and/or bone healing
- The use of pharmaceutical products that block or modify bone healing
- Uncontrolled para-functional diseases (bruxism, clenching or grinding of teeth)
- Insufficient inter-arc gap
- Intraoral infection
- Insufficient coverage of the soft tissue
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Implant survival and success at 12 months post-loading.<br>Success criteria according to Buser and the use or radiographs. Evaluation of any complications and adverse events.
- Secondary Outcome Measures
Name Time Method Change in bone level, changes in soft tissue, aesthetical outcome, patient satisfaction - all at 6, 12, 18, 24, 36, 48, 60 months post-loading and all by evaluating the following parameters:<br>-mesial/distal bone contact at implant (radiograph)<br>-Papilla score (Jemt)<br>- Soft tissue recession (Grunder)<br>- Pink and White esthetic score (Belser)<br>- Volume of soft tissue (intra-oral scan)<br>- Plaque assessment (PPI)<br>- Bleeding on probing (BOP)<br>- Modified gingival index (MGI)<br>- Porbing pocket depths (PPD)<br>- Width of the keratinized mucosa (KM)<br>- Matrix-metalloproteinase 8 (immunology)<br>- Patient satisfaction (PROMs)