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

NCT00780273 | Completed Phase 4 Results

• 1 other identifier: DF 245
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Edentulism

Keywords

subjects with edentulous mandible

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Ankylos dental implants.

EXPERIMENTAL

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

3i Prevail dental implants.

ACTIVE COMPARATOR

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

Interventions

Ankylos Implants DEVICE

ANKYLOS Implant System vs Certain PREVAIL Implant

Ankylos dental implants.

Biomet 3i Prevail Implants DEVICE

3i Prevail dental implants.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dentsply International: lead

Study Sites (1)

University of Rochester, Eastman Dept of Dentistry

Rochester, New York, 14620, United States

Location

Results Point of Contact

• Title: Dr. George Romanos
• Organization: University if Rochester Medical Center

GeorgiosRomanos@urmc.rochester.edu

585-276-4149

Study Officials

• George Romanos, DDS

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2008
• First Posted: October 27, 2008
• Study Start: September 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 19, 2014
• Results First Posted: August 19, 2014

Record last verified: 2014-08

Locations

US (1)