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

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

Official Title
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Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in the Anterior Part of the Mandible and Restored With Fixed Prostheses: a Randomized, Split-mouth, Masked, Prospective, Open, Comparison, Monocenter Trial

Conditions
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Edentulism

Intervention / Treatment
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* Device: Ankylos Implants
* Device: Biomet 3i Prevail Implants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ankylos dental implants.<br>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. | Device: Ankylos Implants<br>* ANKYLOS Implant System vs Certain PREVAIL Implant<br>|
| Active Comparator: 3i Prevail dental implants.<br>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. | Device: Biomet 3i Prevail Implants<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants. | 6 months after surgery | 
| Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants. | 12 months after surgery | 
| Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants. | 24 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subjects with edentulous mandible