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

A 3 Arm Controlled Randomised Study: Comparison of Early and Late Loading Protocols in Full Arch Reconstructions in the Edentulous Maxilla, Using The Cresco Prosthetic System on Straumann Implants

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.

Study Overview

• Status: Completed
• Conditions: Jaw, Edentulous
• Intervention / Treatment: Device: Cresco; Device: Cresco; Device: Straumann components

Detailed Description

The study is a controlled randomised study whereby each patient will receive 5-6 implants placed in the edentulous upper jaw supporting a 10-12 unit screw-retained fixed partial denture (FPD). The main objective of the study is to evaluate the performance of Straumann implants supporting a FPD using Straumann Implants and Cresco restorative components in early and delayed loading protocols at one year post-loading. The treatment groups consist of an early loading and delayed loading arm using Cresco restorative components loading time 10 days post surgery and at 6-8 weeks respectively. The control group comprise the standard delayed loading protocol (healing period 6-8 weeks) and Straumann restorative components. The primary objective is to compare changes in crestal bone levels on radiographs between implants in the control group and test groups at 1 year.The patients will be followed for 3 years.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Kalmar, Sweden, 39185
    • STP Oral protetik
  • Linköping, Sweden, 58185
    • Oral rehabilitering

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Mucosal diseases such as erosive lichen planus
• History of local irradiation therapy
• Presence of osseous lesions
• Unhealed extraction sites (less than 3 months post extraction of teeth in intended sites)
• Bone surgery (bone grafts, guided tissue regeneration technique for bone enhancement) at implant placement.
• Severe bruxing or clenching habits
• Persistent intraoral infection
• Patients with inadequate oral hygiene or unmotivated for adequate home care
• Lack of primary stability of 1 or more implant(s) at surgery. In this instance the patient must be withdrawn and treated accordingly.
• Insufficient bone
• Other: Inability to place implants according to protocol requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cresco early loading; The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery	Device: Cresco; Cresco components loading 10 days post surgery; Device: Cresco; Cresco loading at 6-8 weeks post surgery
Experimental: Cresco late loading; 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; Cresco components loading 10 days post surgery; Device: Cresco; Cresco loading at 6-8 weeks post surgery
Active Comparator: Straumann system late loading; Straumann components loading at 6-8 weeks post surgery	Device: Straumann components; Straumann components loading 6-8 weeks post surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institut Straumann AG
• Investigators: Principal Investigator: Stefan Ellner, DDS, PhD, STP Oral protetik, Kalmar, Sweden; Principal Investigator: Asbjorn Jokstad, Professor, University of Toronto, Faculty of Denistry, 124 Edward Street, Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: June 16, 2009
• First Submitted That Met QC Criteria: June 16, 2009
• First Posted (Estimate): June 17, 2009

Study Record Updates

• Last Update Posted (Estimate): March 31, 2016
• Last Update Submitted That Met QC Criteria: March 3, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous
• Other Study ID Numbers: CR 02/04

Plan for Individual participant data (IPD)

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