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

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

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

Study Overview

• Status: Completed
• Conditions: Edentulism
• Intervention / Treatment: Device: Ankylos Implants; Device: Biomet 3i Prevail Implants

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • University of Rochester, Eastman Dept of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ankylos dental 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.	Device: Ankylos Implants; ANKYLOS Implant System vs Certain PREVAIL Implant
Active Comparator: 3i Prevail dental 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.	Device: Biomet 3i Prevail Implants

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dentsply International
• Investigators: Principal Investigator: George Romanos, DDS, University of Rochester

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: October 24, 2008
• First Submitted That Met QC Criteria: October 24, 2008
• First Posted (Estimate): October 27, 2008

Study Record Updates

• Last Update Posted (Estimate): August 19, 2014
• Last Update Submitted That Met QC Criteria: August 18, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: subjects with edentulous mandible
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Cytochrome P-450 Enzyme Inhibitors; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Cytochrome P-450 CYP1A2 Inhibitors; Histamine H2 Antagonists; Cimetidine
• Other Study ID Numbers: DF 245