Phase 4
N=19
Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses
Edentulism
Bottom Line
View on ClinicalTrials.gov: NCT00780273 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level — 13; 55 Percentage of implants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ankylos Implants (Device); Biomet 3i Prevail Implants (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dentsply International
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level |
11; 70 | — |
| PRIMARY Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level |
11; 70 | — |
| PRIMARY Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level |
11; 70 | — |
Summary
Change in crestal bone level implants at 5% significance level.
Eligibility Criteria
Inclusion Criteria
- age 18 to 80
- male or female (female non-pregnant)
- sufficient oral hygiene
- no inflammation/disorder in the area of implant site
- edentulous mandible and sufficient prosthetic and conservative
- sufficient width and height of bone to place implants with diameters of 4.8mm and length of 11 mm
- provide written informed consent
Exclusion Criteria
- demonstrate a need for pre-surgical bone or soft tissue augmentation in planned implant areas
- exhibit angulation requirements of restoration exceeding 15 degrees
- systemic metabolic disorder that would compromise post-operative tissue regeneration or osseointegration
- taking medication that would compromise post-operative healing and/or osseointegration
- bone disorders such as osteoporosis, hyperparathyroidism, Paget's disease, diabetes mellitus
- oncology treatment
- oral infection
- acute gingivitis and/or periodontitis
- local bone defects in the area of planned implantation
- disorders of oral mucosa (e.g., leukoplakia, oral lichen, pemphigoid lesions)
- received investigational drug within 30 days
- history of illicit drugs or alcohol abuse
- history of addiction to medication
- allergic to dental materials
- nicotine abuse (> 20 cigarettes/day)
- pregnant or nursing
- clinical significant or unstable medical or physiological conditions that would compromise participation in study
- unable or unwilling to return for follow-up visits for a period of 24 months
Data sourced from ClinicalTrials.gov (NCT00780273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.