Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses

Phase 4

Completed

Brief Summary: Change in crestal bone level implants at 5% significance level.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ankylos dental implants.	Ankylos Implants	3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration. A total number of 19 subjects participated in this randomized, split mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who recieved 3 implants on each side which were splinted for the delivery of a fixed prosthesis.
3i Prevail dental implants.	Biomet 3i Prevail Implants	Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration. After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of the 2 parallel treatment groups: one side received ANKYLOS plus implants. The contralateral sde recieved Certain PREVAIL Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated.

Primary Outcome Measures

Name	Time	Method
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level	24 months after surgery	Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.

Secondary Outcome Measures