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OpenTrials
Completed

NCT Number: NCT00780273

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

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

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Rochester, Eastman Dept of Dentistry

Rochester, New York, 14620, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ankylos Implants

Device

ANKYLOS Implant System vs Certain PREVAIL Implant

Biomet 3i Prevail Implants

Device

Primary outcomes

  1. Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level

    Time frame: 6 months after surgery

    Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.

  2. Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level

    Time frame: 12 months after surgery

    Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.

  3. Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level

    Time frame: 24 months after surgery

    Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.

Sponsors and collaborators

Lead sponsor

Dentsply International

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Oct 27, 2008
Registry last updated
Aug 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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