Molar extraction site, immediate placement, delayed loading (loading protocol to be verified with principle investigators)
Conditions
Interventions
Group 1: Immediately after the tooth is extracted, the study dentist will continue to place the study implant (new Straumann TLX implant) in your jawbone. For this, the cavity created by the extractio
Sponsors
Institut Straumann AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Marginal bone level changes 12 months after implant loading. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in marginal bone level 36 months after loading. Implant survival rates 12 and 36 months after loading. Three dimensional Soft tissue volume/level change 12 and 36 months after loading. Bleeding on probing 12 and 36 months after implant loading. Keratinized tissue 12 and 36 months after implant loading. Probing depth 12 and 36 months after implant loading. PI (plaque index) 12 and 36 months after implant loading. Prosthetic survival and success 12 and 36 months after implant loading (mUSPHS criteria). 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. | — |
Countries
Germany, Hong Kong SAR China, Lithuania, Switzerland
Outcome results
None listed