Immediate Function of NobelSpeedy Shorty and Brånemark System® Mk III Shorty Implants in Daily Use

NCT02180230 | Completed Results

• 1 other identifier: T-127
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to evaluate the 7 mm long implants NobelSpeedy Shorty and Brånemark System Mk III Shorty: by determining the marginal bone remodeling, implant survival rate, soft tissue health and maintenance.

Conditions

Partial Edentulism; Complete Edentulism

Keywords

Short implants; prospective multicenter study; maxilla & mandible

Outcome Measures

Primary Outcomes (1)

• Marginal Bone Remodeling

  Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline. Missing data was not imputed and not included in evaluation.

  from implant insertion to 6, 12, 36 and 60 months

Secondary Outcomes (1)

• Cumulative Survival Rates of the Implants

  implant insertion to follow-up visits (6, 12, 36 and 60 months)

Study Arms (1)

Shorty implants

OTHER

Brånemark System Mk III Shorty and/or NobelSpeedy Shorty

Device: Shorty implants

Interventions

Shorty implants DEVICE

Dental implant insertion to maxilla or mandible

Also known as: Brånemark System Mk III Shorty and/or NobelSpeedy Shorty

Shorty implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects should have an osseous architecture enough to receive an implant with a diameter of at least 3.75 mm for Brånemark System Mk III Shorty or 4 mm for NobelSpeedy Shorty and a sufficient amount of bone for placing implants with a length of 7 mm.
• The final tightening torque at installation should be 35-45 Ncm without further rotation and should not exceed 45 Ncm.
• The subject as well as the implant site(s) should fulfill criteria for immediate provizionalization.
• The implants site(s) should be free from extraction remnants.
• The subject should be healthy and compliant with good oral hygiene.
• The subject should be available for the 5-year term of the investigation.
• Favorable and stable occlusal relationship

You may not qualify if:

• Alcohol or drug abuse as noted in patient records or in patient history.
• Health conditions, which do not permit the surgical procedure.
• Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in patient records or in patient history.
• The subject is not able to give her/his informed consent to participate.
• Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation.
• Severe bruxism or other destructive habits.

Sponsors & Collaborators

• Nobel Biocare: lead

Results Point of Contact

• Title: Head of Clinical Trial Management
• Organization: Nobel Biocare

isabelle.arrighi@nobelbiocare.com

+41 43 211 42 00

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: July 2, 2014
• Study Start: October 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 22, 2016
• Results First Posted: April 22, 2016

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share