Overview

This trial is active, not recruiting.

Condition jaw, edentulous, partially
Treatments osseospeed™, nobelspeedy™ replace®, nanotite™ certain® prevail®
Sponsor Dentsply Implants
Start date February 2009
End date June 2017
Trial size 144 participants
Trial identifier NCT00820235, YA-OSS-0003

Summary

The primary objective is to compare the gum response to three different dental implant designs when placed in the front region of the upper jaw. The changes from baseline to one year after will be compared. The null-hypothesis is that the buccal soft tissue (gum) changes from baseline to one year after are equal for all three implant-abutment interface settings.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
osseospeed™
OsseoSpeed™ implant
(Active Comparator)
nobelspeedy™ replace®
NobelSpeedy™ Replace® implant
(Active Comparator)
nanotite™ certain® prevail®
NanoTite™ Certain® PREVAIL® implant

Primary Outcomes

Measure
Buccal soft tissue (gum) changes
time frame: 3-4 weeks (baseline), 12 weeks and 6, 12, 24, 36, 48 and 60 months after implant placement

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Provision of informed consent - At least 18 years - In need of one or more single implants replacing missing or non-restorable teeth in the maxilla within region 14 to 24 The following should be considered at inclusion but can not be fulfilled until at Visit 2: - Edentulous for at least 5 months at study site - A buccal-lingual bone width at study site of at least 5.5 mm - A mesial-distal bone level distance between adjacent teeth at study site of at least 5.5 mm - A keratinized mid-buccal mucosal height of at least 2 mm at study site - Teeth adjacent (mesial and distal) to study site must consist of two stable teeth on natural roots without signs of periodontal bone loss (>1 mm) and/or significant soft tissue loss - Teeth adjacent (mesial and distal) to study site must demonstrate a stable occlusal guidance that will allow non-functional disclusion in all eccentric positions - An opposing dentition with teeth, implants or prosthesis Exclusion Criteria: - Insufficient interocclusal distance for implant placement and restoration at study site - Tooth adjacent (mesial and/or distal) to study site is ankylosed - More than 2 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth - Site development (bone tissue) performed at less than 5 months before Visit 2 at study site - Untreated rampant caries and/or uncontrolled periodontal disease - Class II division 2 malocclusion (Edward Hartley Angle) - Use of tobacco within last 6 months - Uncontrolled diabetes (subjects history does not reveal the absence of control of insulin-dependent/non-insulin dependent Diabetes Mellitus) - Current alcohol or drug abuse - Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration - Use of any substance that will influence bone metabolism - Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration - History of radiation in the head and neck region - Known pregnancy, pregnancy tests will be performed as per local requirements. - Unable or unwilling to return for follow-up visits for a period of 5 years - Unlikely to be able to comply with study procedures according to Investigators judgement - Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study center) - Previous enrollment or randomization of treatment in the present study.

Additional Information

Official title Prospective, Comparative Assessment of Single-tooth Replacement in Different Implant-abutment Settings
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Dentsply Implants.