A 5 Year Clinical Study on NobelActive 3 mm Implants (NA 3 MM)

Open, Prospective, Single Cohort, Multi-centre Study Evaluating the NobelActive 3 mm Implant Immediately Restored With Single Crowns in the Maxillary Lateral Incisor Area or Mandibular Central or Lateral Incisor Area

Multi-centre study evaluating the NobelActive 3.0 mm implant immediately restored with single crowns in the maxillary lateral incisor area or mandibular central or lateral incisor area.

Study Overview

• Status: Completed
• Conditions: Single Tooth Implant
• Intervention / Treatment: Device: Implant NobelActive 3.0

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Obtained informed consent from the subject.
• The subject shall be at least 18 years of age and have passed secession of growth.
• The subject shall be in need of one or more single tooth implant supported restoration(s) in the maxillary lateral incisor or mandibular central or lateral incisor areas of the mouth.
• The subject shall have natural tooth roots present on both sides adjacent to the implant position.
• The subject must be in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems.
• The subject shall have sufficient bone volume at the implant site for placing a NobelActive 3.0 mm implant with a length of at least 10 mm.
• The subject as well as the implant site shall fulfill criteria for immediate provisionalization within 24 hours. A minimum insertion torque of 35 Ncm without further rotation is required.
• The implant site shall be free from tooth remnants.
• If the implant is placed in an extraction site, the extraction socket should have at least 3 intact walls. A dehiscence defect of up to 3 mm is permitted on the fourth wall.
• If the implant is placed in an extraction site, proper and thorough debridement of the extraction socket should be performed.
• The subject shall be healthy and compliant with good oral hygiene.
• The subject shall have a favorable and stable occlusal relationship.

Exclusion Criteria:

• The subject is not able to give her/his informed consent of participating
• Health conditions, which do not permit the surgical treatment.
• Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in subject records or in subject history.
• Any disorders in the planned implant area such as previous tumours, chronic bone disease or previous irradiation.
• Teeth in positions adjacent to the implant site with ongoing infections, endodontic or peri-odontal problems.
• Alcohol or drug abuse as noted in subject records or in subject history.
• Heavy smoking (>10 cigarettes/day).
• Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake.
• Any other disease or medication that might have an influence on the involved tissues, such as intake of bisphosphonates, treatment with heparine, osteogenesis imperfecta, osteoporosis etc.
• Severe bruxism or other destructive habits.
• If the implant is not able to withstand a final torque of 35 Ncm without further rotation, or if the implant for any other reason cannot be immediately provisionalized, as judged by the clinician, the implant will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NobelActive 3.0	Device: Implant NobelActive 3.0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal bone level changes	Marginal bone level changes over time around the NobelActive 3.0 mm implant	5 years

Collaborators and Investigators

• Sponsor: Nobel Biocare

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 5, 2020
• Study Completion (Actual): March 5, 2020

Study Registration Dates

• First Submitted: July 3, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: single tooth implant; supported restoration(s); maxillary lateral incisor; mandibular central incisor; lateral incisor; areas of the mouth
• Other Study ID Numbers: T 176

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No