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

Phase 4

Completed

Conditions: Jaw, Edentulous

Interventions: Device: Straumann components
Device: Cresco

Registration Number: NCT00922935

Lead Sponsor: Institut Straumann AG

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Straumann system late loading	Straumann components	Straumann components loading at 6-8 weeks post surgery
Cresco early loading	Cresco	The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
Cresco late loading	Cresco	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.

Primary Outcome Measures

Name	Time	Method
Bone Level Change on Radiographs	3 years after loading	Crestal bone level change at implant margin.The difference between baseline and 3 years after loading.

Secondary Outcome Measures