This trial is active, not recruiting.

Conditions partial edentulism, tooth disease
Treatments implant with new abutment connection, nanotite certain tapered implant
Phase phase 1
Sponsor Biomet, Inc.
Start date July 2011
End date December 2016
Trial size 49 participants
Trial identifier NCT01529814, 3012


Integration success rates measured by resistance to countertorque testing will be higher for the experimental implant design than for the control implants.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Implant with new abutment connection
implant with new abutment connection Osseotite Endosseous dental implant
New abutment connection implant system
(Active Comparator)
Nanotite Certain Tapered (standard abutment connection) implant
nanotite certain tapered implant Nanotite endosseous dental implant
Nanotite Certain Tapered (standard abutment connection) implant

Primary Outcomes

Primary stability countertorque measures
time frame: 2 months

Secondary Outcomes

Cumulative success rate
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - patients of either sex and older than 18 years of age - patients needing at least one dental implant to treat partial edentulism - patients physically able to tolerate surgical and restorative dental procedures - patients agreeing to all protocol visits Exclusion Criteria: - patients with infection or severe inflammation at the intended treatment sites - patients smoking greater than 10 cigarettes per day - patients with uncontrolled diabetes mellitus - patients with uncontrolled metabolic diseases - patients who received radiation treatment to the head in the past 12 months - patients needing bone grafting at the intended treatment sites - patients known to be pregnant at screening visit - patients with para-functional habits like bruxing and clenching

Additional Information

Official title A Prospective Randomized-controlled Study of the Integration Success Rate of an Implant System With a Novel Abutment Attachment in Cases Loaded Early
Principal investigator Carlos Montoya, DDS
Description In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by countertorque testing and cumulative success rate in cases that are loaded early
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..