Partial Edentulism, Tooth Disease
Conditions
Keywords
edentulism, dental implants, clinical study, Nanotite Certain Tapered implant, randomized, crestal bone level
Brief summary
Integration success rates and the preservation of crestal bone will be higher for the experimental device than for the control implants.
Detailed description
In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by lack of implant mobility and lack of bone loss obtained at various study time points
Interventions
New abutment connection implant
Nanotite Certain Tapered (standard abutment connection) implant
Sponsors
ZimVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients of either sex and older than 18 years of age * patients needing at least one dental implant to treat partial edentulism * patients physically able to tolerate surgical and restorative dental procedures * patients agreeing to all protocol visits
Exclusion criteria
* patients with infection or severe inflammation at the intended treatment sites * patients smoking greater than 10 cigarettes per day * patients with uncontrolled diabetes mellitus * patients with uncontrolled metabolic diseases * patients who received radiation treatment to the head in the past 12 months * patients needing bone grafting at the intended treatment sites * patients known to be pregnant at screening visit * patients with para-functional habits like bruxing and clenching
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative success rate | 2 years | Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility) |
Countries
Colombia
Outcome results
None listed