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

Dentsply

Status and phase: Completed; Phase 4

Conditions: Edentulism

Treatments: Device: Ankylos Implants; Device: Biomet 3i Prevail Implants

Study type: Interventional

Funder types: Industry

Identifiers

NCT00780273

DF 245

Details and patient eligibility

About

Change in crestal bone level implants at 5% significance level.

Enrollment: 19 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

19 participants in 2 patient groups

Ankylos dental implants.

Experimental group

Description:

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.

Treatment:

Device: Ankylos Implants

3i Prevail dental implants.

Active Comparator group

Description:

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.

Treatment:

Device: Biomet 3i Prevail Implants