Immediate implant placement in molar extraction sockets using fully tapered tissue level implants: a randomized controlled post-market multinational clinical study
- Conditions
- Molar extraction site, immediate placement, delayed loading (loading protocol to be verified with principle investigators)
- Registration Number
- DRKS00027236
- Lead Sponsor
- Institut Straumann AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 144
Patients must have voluntarily signed the informed consent form before any study related procedures
- Patients must be a minimum of 18 years of age
- Periodontally healthy patients (no PPD greater than 4 mm except failing molar or PPD at implants higher than 6 mm)
- Patients who are in need of a molar extraction (failing tooth) of the maxilla or mandible and replacement with a dental implant
- Planned site for implant must have a natural tooth or implant mesially or distally in the adjacent tooth positions
- Patients must have an opposing tooth (natural teeth or implant, fixed or removable restorations) to the planned site
- Patients must be committed to the study and the required follow-up visits
- Patients with a systemic disease that would preclude dental implant surgery
- Patients with any contraindications for oral surgical procedures
- Patients with mucosal diseases (e.g., erosive lichen planus) in the localized area around the study implant site
- Patients with a history of local irradiation therapy in the head/neck area
- Patients with any untreated endodontic lesions or untreated periodontal disease adjacent to the implant site
- Patients receiving, or having a history of receiving, intravenous or subcutaneous antiresorptive agents, such as bisphosphonates
- Patients with inadequate oral hygiene (PI higher than 30%) or who are unmotivated for adequate oral hygiene
- Patients who have physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
- Patients who are pregnant or intending to become pregnant during the duration of the study
- Patients who are heavy smokers (defined as >10 cigarettes per day or >1 cigar per day) or chew/dip tobacco
- Patients with confirmed alcoholism or known drug abuse (as per medical records)
- Patients who have undergone administration of any investigational device within 30 days of enrolment in the study
- Patients with 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 Marginal bone level changes 12 months after implant loading.
- Secondary Outcome Measures
Name Time Method Change in marginal bone level 36 months after loading. <br>Implant survival rates 12 and 36 months after loading.<br>Three dimensional Soft tissue volume/level change 12 and 36 months after loading.<br>Bleeding on probing 12 and 36 months after implant loading.<br>Keratinized tissue 12 and 36 months after implant loading.<br>Probing depth 12 and 36 months after implant loading.<br>PI (plaque index) 12 and 36 months after implant loading.<br>Prosthetic survival and success 12 and 36 months after implant loading (mUSPHS criteria).<br>Assessment of patient satisfaction (Patient Reported Outcome Measures (PROMs); test at visits 1-5, control/comparator at visits 1-7) and operator experience (Operation Reported Outcome Measures (OROMs), test at visits 2, 4, 5, control/comparator at visits 2, 4, 6, 7) during treatment.<br>