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

• ClinicalTrials.gov Identifier: NCT00780273
• Recruitment Status: Completed
• First Posted: October 27, 2008
• Results First Posted: August 19, 2014
• Last Update Posted: August 19, 2014
• Sponsor: Dentsply International
• Information provided by (Responsible Party): Dentsply International

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Edentulism	Device: Ankylos Implants; Device: Biomet 3i Prevail Implants	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: September 2008
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: April 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Dentsply International
• ClinicalTrials.gov Identifier: NCT00780273
• Other Study ID Numbers: DF 245
• First Posted: October 27, 2008
• Results First Posted: August 19, 2014
• Last Update Posted: August 19, 2014
• Last Verified: August 2014

Keywords provided by Dentsply International:

subjects with edentulous mandible

Additional relevant MeSH terms:

Cimetidine; Anti-Ulcer Agents; Gastrointestinal Agents; Histamine H2 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors