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

• Sponsor: Institut Straumann AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00922935
• Collaborator: (none)
• Enrollment: 36
• Locations: 2
• Arms: 3
• Duration (Months): 59
• Patients Per Site: 18
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Jaw, Edentulous	Device: Cresco; Device: Cresco; Device: Straumann components	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Oct 1, 2004
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

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
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 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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	STP Oral protetik	Kalmar		Sweden	39185
2	Oral rehabilitering	Linköping		Sweden	58185

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Straumann AG
• ClinicalTrials.gov Identifier: NCT00922935
• Other Study ID Numbers: CR 02/04
• First Posted: Jun 17, 2009
• Last Update Posted: Mar 31, 2016
• Last Verified: Mar 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Jaw, Edentulous; Mouth, Edentulous

Study Results

Participant Flow

Arm/Group Title	Cresco Early Loading	Cresco Late Loading	Straumann System Late Loading
Arm/Group Description	The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery	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.	Straumann components loading at 6-8 weeks post surgery
Period Title: Overall Study
STARTED	10	16	10
COMPLETED	9	11	10
NOT COMPLETED	1	5	0

Baseline Characteristics

Arm/Group Title	Cresco Early Loading	Cresco Late Loading	Straumann System Late Loading	Total
Arm/Group Description	The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery	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.	Straumann components loading at 6-8 weeks post surgery	Total of all reporting groups
Overall Participants	10	16	10	36
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	3 30%	9 56.3%	6 60%	18 50%
>=65 years	7 70%	7 43.8%	4 40%	18 50%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.1 (12.2)	64.2 (10.7)	67.1 (7)	65.1 (9.9)
Sex: Female, Male (Count of Participants)
Female	3 30%	8 50%	9 90%	20 55.6%
Male	7 70%	8 50%	1 10%	16 44.4%
Region of Enrollment (participants) [Number]
Sweden	10 100%	16 100%	10 100%	36 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cresco Early Loading	Cresco Late Loading	Straumann System Late Loading
Arm/Group Description	The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery	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.	Straumann components loading at 6-8 weeks post surgery
Measure Participants	10	16	10
Mean (Standard Deviation) [mm]	2.91 (0.7)	2.11 (0.64)	1.70 (0.94)

Adverse Events

Arm/Group Title	Cresco Early Loading		Cresco Late Loading		Straumann System Late Loading
Arm/Group Description	The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery		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.		Straumann components loading at 6-8 weeks post surgery
All Cause Mortality
	Cresco Early Loading		Cresco Late Loading		Straumann System Late Loading
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Cresco Early Loading		Cresco Late Loading		Straumann System Late Loading
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		1/16 (6.3%)		0/10 (0%)
Blood and lymphatic system disorders
Trombosis left leg	1/10 (10%)	1	0/0 (NaN)	0	0/10 (0%)	0
General disorders
Death	0/10 (0%)	0	1/16 (6.3%)	1	0/10 (0%)	0
Psychiatric disorders
Disoriented, depressed	0/10 (0%)	0	1/16 (6.3%)	1	0/10 (0%)	0
Other (Not Including Serious) Adverse Events
	Cresco Early Loading		Cresco Late Loading		Straumann System Late Loading
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/16 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.