Comparison of Early and Late Loading in the Edentulous Upper Jaw Using Cresco Prosthetic System on Straumann Implants

NCT00922935 | Completed Phase 4 Results

• 1 other identifier: CR 02/04
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

Comparison of early and late loading of implants supporting full each prosthesis in upper jaw, using the Cresco prosthetic system on Straumann implants. The study hypothesis is that there is no difference between the bone loss (or gain) between the groups.

Conditions

Jaw, Edentulous

Outcome Measures

Primary Outcomes (1)

• Bone Level Change on Radiographs

  Crestal bone level change at implant margin.The difference between baseline and 3 years after loading.

  3 years after loading

Study Arms (3)

Cresco early loading

EXPERIMENTAL

The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery

Device: Cresco

Cresco late loading

EXPERIMENTAL

Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before "try ins" to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.

Device: Cresco

Straumann system late loading

ACTIVE COMPARATOR

Straumann components loading at 6-8 weeks post surgery

Device: Straumann components

Interventions

Cresco DEVICE

Cresco components loading 10 days post surgery

Cresco early loading

Straumann components DEVICE

Straumann components loading 6-8 weeks post surgery

Straumann system late loading

Eligibility Criteria

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

You may qualify if:

• Males and females must be at least 18 years of age.
• Be edentulous in the maxilla and subjectively desire an implant supported screw retained FPD
• The teeth at the implant site must have been extracted or lost at least 3 months before the date of implantation.
• In the case of Guided Bone Regeneration(GBR) or Guided Tissue Regeneration (GTR) treatments, these procedures must have been completed at least 6 months prior to intended surgery date (to fulfil point 5).
• Adequate bone quality and quantity at the six, minimum five, implant sites to permit the insertion of Straumann 4.1 and 3.3 mm diameter implants without the use of concurrent bone augmentation techniques. I.e. implant insertion sites must have sufficient bone height such that the implant will not encroach on vital structures and sufficient width that a minimum of 1 mm of palatal and buccal bone will remain.
• Patients must be committed to participate in the study for three years follow-up examinations

You may not qualify if:

• Presence of conditions requiring chronic routine prophylactic use of antibiotics (e. g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements)
• Medical conditions requiring prolonged use of steroids
• History of leukocyte dysfunction and deficiencies
• History of bleeding disorders
• History of neoplastic disease requiring the use of radiation or chemotherapy
• Patients with history of renal failure
• Patients with metabolic bone disorders
• History of uncontrolled endocrine disorders
• Physical handicaps that would interfere with the ability to perform adequate oral hygiene
• Use of any investigational drug or device within the 30-day period immediately prior to implant surgery on study day 0.
• Alcoholism or drug abuse
• Patients infected with HIV
• Patients who smoke more than 10 cigarettes per day or cigar equivalents, or who chew tobacco (not greater than 10 cigarette equivalents)
• Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability.
• Local inflammation, including untreated periodontitis

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (2)

STP Oral protetik

Kalmar, 39185, Sweden

Location

Oral rehabilitering

Linköping, 58185, Sweden

Location

Related Publications (1)

• Jokstad A, Ellner S, Gussgard A. Comparison of two early loading protocols in full arch reconstructions in the edentulous maxilla using the Cresco prosthetic system: a three-arm parallel group randomized-controlled trial. Clin Oral Implants Res. 2011 May;22(5):455-63. doi: 10.1111/j.1600-0501.2010.02156.x. Epub 2011 Mar 24.

  PMID: 21435016 RESULT

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Kristina Espemar Holst, Senior Clinical Trial Manager
• Organization: Straumann

info@straumann.com

+41 61 965 11 11

Study Officials

• Stefan Ellner, DDS, PhD

  STP Oral protetik, Kalmar, Sweden

  PRINCIPAL INVESTIGATOR

• Asbjorn Jokstad, Professor

  University of Toronto, Faculty of Denistry, 124 Edward Street, Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: October 1, 2004
• Primary Completion: February 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 31, 2016
• Results First Posted: July 12, 2011

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)