Single or multiple teeth missing in both jaws Oral Health
Conditions
Interventions
Replacement of missing teeth with tissue level implants (TLX) and recording of clinical data at every follow-up visit. There will be no randomization.
Sponsors
Straumann (Switzerland)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years old and over 2. Requiring a single or partial fixed implant prosthesis (FDP) of maxillary and mandibular arch 3. Otherwise healthy patients 4. Full mouth bleeding and full mouth plaque index lower than or equal to 25% 5. Bone height for at least 4 mm-long implants 6. Bone width of at least 3 mm and 4 mm 7. Fresh extraction sockets with an intact buccal wall
Exclusion criteria
Exclusion criteria: 1. Psychiatric contraindications 2. Pregnancy or nursing 3. Any interfering medication such as: 3.1. Steroid therapy 3.2. Bisphosphonate therapy 4. Alcohol or drug abuse 5. Heavy smoking (>10 cigarettes/day) 6. Radiation therapy to head or neck region within 5 years 7. Untreated periodontitis 8. Acute and chronic infections of the adjacent tissues or natural dentition 9. Severe maxillomandibular skeletal discrepancy 10. High and moderate parafunctional activity 11. Absence of opposite teeth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Implantation survival rate (ISR) measured during a control visit every 4 months. A surviving implant is an implant that maintains its function in the mouth. 2. Marginal bone loss (MBL) measured using annual periapical X-rays | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Initial implant stability quotient values (ISQ-0) and insertion torque at implant placement recorded at each scheduled visit every 4 months from implant placement 2. Peri-implant soft tissue parameters recorded at each scheduled visit every 4 months from implant placement: 2.1. Bleeding on probing (BoP) measured using a periodontal probe 2.2. Probing depth (PD) measured using a periodontal probe 2.3. Implant stability measured using ISQ values from a resonance frequencies analysis using the Osstel device | — |
Countries
Italy
Outcome results
None listed