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

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.

Study Overview

• Status: Completed
• Conditions: Partial Edentulism; Complete Edentulism
• Intervention / Treatment: Device: Shorty implants

Detailed Description

The primary endpoint was the change in marginal bone levels (in mm) from the time of implant insertion to follow-up visits (3, 6, 12, 36 and 60 months).

Further endpoints were:

• cumulative survival rates of the implants
• soft tissue parameters (papilla index, bleeding on probing)
• plaque formation

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.
• Immediate insertion (e.g. placement of the implant immediately after extraction) will not constitute an exclusion criterion.
• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Shorty implants; Brånemark System Mk III Shorty and/or NobelSpeedy Shorty	Device: Shorty implants; Dental implant insertion to maxilla or mandible; Other Names: Brånemark System Mk III Shorty and/or NobelSpeedy Shorty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Survival Rates of the Implants	An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument).	implant insertion to follow-up visits (6, 12, 36 and 60 months)

Collaborators and Investigators

• Sponsor: Nobel Biocare

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 26, 2014
• First Submitted That Met QC Criteria: June 30, 2014
• First Posted (Estimate): July 2, 2014

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: March 22, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Short implants; prospective multicenter study; maxilla & mandible
• Other Study ID Numbers: T-127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO