NCT02178891UnknownNot Applicable
A 5-year Clinical Evaluation on Brånemark System® RP Ø4.5x4.5 mm Implants
Nobel Biocare2 sites in 1 country144 target enrollmentStarted: January 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 144
- Locations
- 2
- Primary Endpoint
- marginal bone level changes
Study Overview
Brief Summary
An extra short, 2-piece implant with a Brånemark hexagon interface was developed with a bone anchoring length of only 4.5 mm, for subjects with severely resorbed jaws.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •The subject should be at least 18 years of age and have passed secession of growth
- •The subject should be in need of an implant-supported restoration in the posterior region of the mouth (maxilla: first premolar to third molar, mandible: first premolar to second molar, not third molar due to mobile gingiva), where at least 2 implants are needed of which at least one should be an Extra Short Implant
- •Obtained informed consent from the subject
- •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 should have a severely resorbed posterior mandible and/ or maxilla.
- •Implants are only to be placed in healed sites, defined as a site with minimum 6 months of healing following tooth extraction
- •At least 6 mm residual bone width, between 4-7 mm residual bone height in the maxilla and between 6-9 mm residual bone height in the mandible
- •At implant installation the implant should be stable; final tightening torque of the implant about 25 Ncm or higher, preferably not exceeding 45 Ncm
- •The subject should be healthy and compliant with good oral hygiene
- •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
- •Alcohol or drug abuse as noted in subject records or in subject history.
- •Heavy smoking (>10 cigarettes/day)
- •Intake of medication containing bisphosphonates
- •Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake
- •Severe bruxism or other destructive habits
- •Immediate insertion (i.e. placement of the implant immediately after extraction)
- •Bone augmentation procedures before or at implant installation is not allowed
- •Deviation from stated drilling protocol, utilizing osteotomes, is not allowed
- •Lack of opposing dentition
- •Single crown restorations are not to be performed in the study
Arms & Interventions
short implants
Other
Intervention: extra short implant (Device)
Outcomes
Primary Outcomes
marginal bone level changes
Time Frame: yearly, up to 5 years
Secondary Outcomes
- cumulative survival and success rates(yearly, up to 5 years)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Peri-Implant Healing Around Two Different Machined-Collar Designs After 25 Years of FunctionJaw, EdentulousNCT03862482Université de Montréal22
Completed
Not Applicable
An Implant With an Acid-etched Fixture Surface and Internal-hex Collar May Achieve Greater Osseointegration.Jaw, EdentulousDental ImplantNCT01641198Université de Montréal58
Completed
Not Applicable
Clinical Performance of a New Implant System for Bone Conduction HearingMixed Hearing LossSensoneural Single Sided DeafnessConductive Hearing LossNCT03086135Cochlear51
Completed
Not Applicable
Clinical performance of a new implant system for bone conduction hearing10019243Hearing lossdeafnessNL-OMON47361Cochlear Bone Anchored Solutions AB10
Recruiting
Not Applicable
Evaluation of 3D printed bone implant in skull and the face surgeryAbsorbable bone implants to correct craniofacial abnormalities.Presence of other bone and tendon implantsZ96.7IRCT20220807055633N1Esfahan University of Medical Sciences7