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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply International
ClinicalTrials.gov Identifier:
NCT00780273
First received: October 24, 2008
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Edentulism
Device: Ankylos Implants
Device: Biomet 3i Prevail Implants
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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

Further study details as provided by Dentsply International:

Primary Outcome Measures:
  • Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.

  • Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.

  • Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level [ Time Frame: 24 months after surgery ] [ Designated as safety issue: No ]
    Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.


Enrollment: 19
Study Start Date: September 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780273

Locations
United States, New York
University of Rochester, Eastman Dept of Dentistry
Rochester, New York, United States, 14620
Sponsors and Collaborators
Dentsply International
Investigators
Principal Investigator: George Romanos, DDS University of Rochester
  More Information

No publications provided

Responsible Party: Dentsply International
ClinicalTrials.gov Identifier: NCT00780273     History of Changes
Other Study ID Numbers: DF 245
Study First Received: October 24, 2008
Results First Received: March 17, 2014
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dentsply International:
subjects with edentulous mandible

ClinicalTrials.gov processed this record on September 30, 2014