Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional Teeth Attached 6-7 Weeks Later

NCT00711113 | Completed Results

• 1 other identifier: YA-OSS-0001
• Study Type: interventional
• Target: 47
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior maxilla in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.

Conditions

Jaw, Edentulous, Partially

Keywords

Jaw, Edentulous, Partially (posterior maxilla)

Outcome Measures

Primary Outcomes (3)

• Implant Survival Rate

  An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.

  At 5 year follow-up

• Implant Stability

  Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (\<60) indicate low stability, medium values (60-70) indicate medium stability and high values (\>70) indicate high stability.

  At 1 year follow-up

• Marginal Bone Adaptation

  Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.

  At baseline (loading) and at 5 year follow-up

Study Arms (1)

A

EXPERIMENTAL

Device: OsseoSpeed™

Interventions

OsseoSpeed™ DEVICE

OsseoSpeed™, all dimensions

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• years of age and over
• Edentulous in the posterior maxilla, Kennedy classes I or II. Last natural tooth, or previously restored implant in function is canine or first bicuspid.
• Deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading

You may not qualify if:

• Untreated caries and/or periodontal disease of residual dentition
• History of edentulism in the area of implant placement of less than two months
• Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
• History of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area.
• Sinus floor thickness of less than 5 mm, verified by periapical radiographs.
• Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
• Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
• Present alcohol or drug abuse
• Unable or unwilling to return for follow-up visits for a period of 5 years
• Current use of smoking tobacco
• Pregnancy or lactation at the time of enrollment

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (3)

University of Iowa, College of Dentistry, Dow's Institute for Dental Research

Iowa City, Iowa, 52242-1010, United States

Location

UTHSCSA

San Antonio, Texas, 78229, United States

Location

Universitetsklinik Mainz, Klinik fur ZMK

Mainz, D-551 31, Germany

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially; Mouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases

Results Point of Contact

• Title: Manager Global Clinical Operations
• Organization: DENTSPLY Implants

+46313763500

Study Officials

• James T Mellonig, D.D.S., M.S

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 8, 2008
• Study Start: December 1, 2003
• Primary Completion: September 1, 2011
• Last Updated: February 7, 2014
• Results First Posted: February 7, 2014

Record last verified: 2014-01

Locations

US (2); DE (1)