Study on OsseoSpeed™ Implants in Patients Missing 2-5 Teeth in the Posterior Lower Jaw, Restored With Permanent Teeth Attached 6-7 Weeks Later

• Sponsor: Dentsply Sirona Implants (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00711425
• Collaborator: (none)
• Enrollment: 45
• Locations: 3
• Arm: 1
• Patients Per Site: 15

Study Details

Study Description

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 mandible in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.

Condition or Disease	Intervention/Treatment	Phase
Jaw, Edentulous, Partially	Device: OsseoSpeed™	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open, Prospective Study to Evaluate Implant Stability, Marginal Bone Adaptation and the Survival Rate of Astra Tech Dental Implant System, Fixture Osseospeed™, in Patients With Tooth Loss in the Posterior Mandible in an Early Loading Protocol.
• Study Start Date: Feb 1, 2004
• Actual Primary Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Device: OsseoSpeed™; OsseoSpeed™, all dimensions

Outcome Measures

Primary Outcome Measures

1. Implant Survival Rate [At 5 year follow-up]

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

2. Implant Stability [At 1 year follow-up]

   Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100.

3. Marginal Bone Adaptation [At 5 year follow-up]

   Marginal bone adaptation will be 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 will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Provision of written informed consent

• 18 years of age and over

• Edentulous in the posterior mandible, Kennedy class I or class 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

Exclusion Criteria:

• 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.

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University, College of Dentistry	Columbus	Ohio	United States	43210-1241
2	University of Washington, Dept. of Restorative Dentistry	Seattle	Washington	United States	98195
3	Georg-August-Universität, Göttingen, Abt. Mund-, Keifer-, und Gesicthschirurgie	Göttingen		Germany	37075

Sponsors and Collaborators

• Dentsply Sirona Implants

Investigators

• Principal Investigator: Edwin A McGlumphy, D.D.S., The Ohio State University, College of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dentsply Sirona Implants
• ClinicalTrials.gov Identifier: NCT00711425
• Other Study ID Numbers: YA-OSS-0002
• First Posted: Jul 8, 2008
• Last Update Posted: Sep 9, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by Dentsply Sirona Implants: Jaw, Edentulous, Partially (posterior mandible)
• Additional relevant MeSH terms: Jaw, Edentulous; Jaw, Edentulous, Partially; Mouth, Edentulous

Study Results

Participant Flow

Arm/Group Title	OsseoSpeed
Arm/Group Description	Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Period Title: Overall Study
STARTED	45
COMPLETED	41
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	OsseoSpeed
Arm/Group Description	Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Overall Participants	44
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57 (10)
Sex: Female, Male (Count of Participants)
Female	22 50%
Male	22 50%
Region of Enrollment (participants) [Number]
United States	29 65.9%
Germany	15 34.1%

Outcome Measures

1. Primary Outcome

Title	Implant Survival Rate
Description	An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. The survival rate for individual implants will be analyzed at each visit. Cumulative implant survival rate will be calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
Time Frame	At 5 year follow-up

Outcome Measure Data

Analysis Population Description

Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients).

Arm/Group Title	OsseoSpeed
Arm/Group Description	Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Measure Participants	44
Measure Implants	134
Number [Percentage of implants]	100

2. Primary Outcome

Title	Implant Stability
Description	Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100.
Time Frame	At 1 year follow-up

Outcome Measure Data

Analysis Population Description

Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients).At 1-year follow-up, 43 patients were still in the study and thus evaluable for the analysis.

Arm/Group Title	OsseoSpeed
Arm/Group Description	Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Measure Participants	43
Measure Implants	130
Mean (Standard Deviation) [ISQ]	77.4 (7.1)

3. Primary Outcome

Title	Marginal Bone Adaptation
Description	Marginal bone adaptation will be 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 will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.
Time Frame	At 5 year follow-up

Outcome Measure Data

Analysis Population Description

Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients). At 5-year follow-up, 41 patients were still in the study and thus evaluable for the analysis.

Arm/Group Title	OsseoSpeed
Arm/Group Description	Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Measure Participants	41
Measure Implants	123
Mean (Standard Deviation) [Millimeter]	-0.05 (1.96)

Adverse Events

Arm/Group Title	OsseoSpeed
Arm/Group Description	Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
All Cause Mortality
	OsseoSpeed
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	OsseoSpeed
	Affected / at Risk (%)	# Events
Total	17/45 (37.8%)
Cardiac disorders
HEART ATTACK	2/45 (4.4%)	2
Gastrointestinal disorders
INTESTINAL PAIN	1/45 (2.2%)	1
Infections and infestations
TOXAEMIA AT RIGHT FOOT	1/45 (2.2%)	1
Investigations
PT HAD MRI, CT SCAN + COLON OSCOPY DUE TO PAIN ON R ABDOMEN	1/45 (2.2%)	1
Musculoskeletal and connective tissue disorders
LOWER LUMBAR PAIN	1/45 (2.2%)	1
SHOULDER PAIN	1/45 (2.2%)	1
Renal and urinary disorders
KIDNEY ABCESS	1/45 (2.2%)	1
Respiratory, thoracic and mediastinal disorders
BACTERIAL LUNG INFECTION LED TO COLLAPSED LUNG	1/45 (2.2%)	1
Surgical and medical procedures
FLUID MASS REMOVED FROM LUNG AFTER INFECTION CLEARED	1/45 (2.2%)	1
HYSTERECTOMY	1/45 (2.2%)	1
HEART SURGERY (4 BYPASSES)	1/45 (2.2%)	1
INJECTIONS BECAUSE OF PAIN IN THE LUMBAR SPINE	1/45 (2.2%)	1
OPERATION, SECOND STENT	1/45 (2.2%)	1
CLEANSING OF FRONTAL SINUS	1/45 (2.2%)	1
CYSTECTOMIA, ABLATION OF WISDOM TEETH	1/45 (2.2%)	1
Vascular disorders
AORTIC ANEURYSM	1/45 (2.2%)	1
Other (Not Including Serious) Adverse Events
	OsseoSpeed
	Affected / at Risk (%)	# Events
Total	0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.