Dental Implant Failure Nos
Conditions
Brief summary
To assess implant outcomes, both clinical and radiological, in a randomized study on guided implant placement after 3-year follow-up, compared to non-guided treatment.
Interventions
PROCEDUREGuided placement
implant placement with use of guide
PROCEDURENon-guided placement
conventional implant placement
DEVICEAstra Tech TX implant
Sponsors
Dentsply Sirona Implants and Consumables
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Provision of informed consent 2. An age of at least 18 year 3. Extraction socket healing for at least 6 months
Exclusion criteria
1. Unlikely to be able to comply with study procedures 2. History of intravenous bisphosphonate treatment 3. Medical history that makes implant insertion unfavorable 4. Current pregnancy 5. Present alcohol and/or drug abuse 6. Major systemic diseases 7. Untreated, uncontrolled caries and/or periodontal disease 8. History of local irradiation 9. Need for bone grafting and/or sinus lift in the planned implant area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic outcome | Change between baseline and 3 Year | Bone loss in mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| probing pocket depth | Change between baseline and 3 Year | measurement in mm of pocket around implant, 4 per implant |
| bleeding on probing | Change between baseline and 3 Year | measurement of presence of bleeding on probing, Yes =1, No=0. 4 per implant |
| plaque | Change between baseline and 3 Year | measurement of presence of plaque, Yes =1, No=0. 4 per implant |
Outcome results
None listed