Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading

• Sponsor: Dentsply Sirona Implants (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00748241
• Collaborator: (none)
• Enrollment: 19
• Locations: 2
• Arm: 1
• Patients Per Site: 9.5

Study Details

Study Description

Brief Summary

The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and the implants will be loaded four weeks after implant installation (early loading). Marginal bone levels, plaque and status of the periimplant mucosa will also be evaluated. The subjects will be followed for three years.

Condition or Disease	Intervention/Treatment	Phase
Jaw, Edentulous, Partially	Device: Astra Tech Fixture ST	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Prospective Study to Evaluate the Survival Rate and Marginal Bone Response of Astra Tech Dental Implants, Fixture ST, in Patients With Tooth Loss in the Posterior Maxilla.
• Study Start Date: Sep 1, 2000
• Actual Primary Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Astra Tech Fixture ST	Device: Astra Tech Fixture ST; Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.

Outcome Measures

Primary Outcome Measures

1. Implant Survival Rate [At follow-up visit: 6 months after implants have been loaded]

   An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.

2. Implant Survival Rate [At follow-up visit: 1 year after implants have been loaded]

   An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.

3. Implant Survival Rate [At follow-up visit: 2 years after implants have been loaded]

   An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.

4. Implant Survival Rate [At follow-up visit: 3 years after implants have been loaded]

   An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.

Secondary Outcome Measures

1. Implant Failure [3 years after implant placement]

   Total number of implants reported as failure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 - 75

• Unilateral or bilateral edentulism in the posterior maxilla, last tooth should be the canine or the first bicuspid

• Willing to give informed consent

Exclusion Criteria:

• Bone height < 5 mm, in the planned implant area

• Bone width < 5 mm, in the planned implant area

• Previous bone augmentation procedure in the planned implant area

• Previous failures of endosseous implants

• Untreated caries and/or periodontal disease of residual dentition

• History or presence of any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration

• Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration

• Current alcohol or drug abuse

• Unable or unwilling to return for follow-up visits for 3 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Periodontology, New York Dept of Veterans Affairs Medical Center	New York	New York	United States	10010
2	Dept. of Prosthodontics, New York Dept of Veterans Affairs Medical Center	New York	New York	United States	10010

Sponsors and Collaborators

• Dentsply Sirona Implants

Investigators

• Principal Investigator: Bruce G Valauri, D.D.S., New York Dept of Veterans Affairs Medical Center
• Principal Investigator: Michael Toffler, D.D.S., New York Dept of Veterans Affairs Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dentsply Sirona Implants
• ClinicalTrials.gov Identifier: NCT00748241
• Other Study ID Numbers: YA-MIC-0002
• First Posted: Sep 8, 2008
• Last Update Posted: Feb 15, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Jaw, Edentulous; Jaw, Edentulous, Partially

Study Results

Participant Flow

Arm/Group Title	Astra Tech Fixture ST
Arm/Group Description	Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Period Title: Overall Study
STARTED	19
COMPLETED	11
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Astra Tech Fixture ST
Arm/Group Description	Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Overall Participants	19
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.0 (11.3)
Sex: Female, Male (Count of Participants)
Female	2 10.5%
Male	17 89.5%
Region of Enrollment (participants) [Number]
United States	19 100%

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. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Time Frame	At follow-up visit: 6 months after implants have been loaded

Outcome Measure Data

Analysis Population Description

Population includes subjects who completed the 6 month visit (2 subjects missed the 6 month visit but completed the 1 year visit).

Arm/Group Title	Astra Tech Fixture ST
Arm/Group Description	Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Measure Participants	14
Measure Implants	53
Number [Percentage of implants]	89.9

2. 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. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Time Frame	At follow-up visit: 1 year after implants have been loaded

Outcome Measure Data

Analysis Population Description

Population includes subjects who completed 12 month visit.

Arm/Group Title	Astra Tech Fixture ST
Arm/Group Description	Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Measure Participants	15
Measure Implants	52
Number [Percentage of implants]	89.9

3. 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. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Time Frame	At follow-up visit: 2 years after implants have been loaded

Outcome Measure Data

Analysis Population Description

Population includes subjects who completed 24 month visit.

Arm/Group Title	Astra Tech Fixture ST
Arm/Group Description	Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Measure Participants	13
Measure Implants	43
Number [Percentage of implants]	89.9

4. 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. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Time Frame	At follow-up visit: 3 years after implants have been loaded

Outcome Measure Data

Analysis Population Description

Population includes subjects who completed 36 month visit.

Arm/Group Title	Astra Tech Fixture ST
Arm/Group Description	Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Measure Participants	11
Measure Implants	39
Number [Percentage of implants]	89.9

5. Secondary Outcome

Title	Implant Failure
Description	Total number of implants reported as failure.
Time Frame	3 years after implant placement

Outcome Measure Data

Analysis Population Description

Number of failed implants based on total number of patients enrolled and total number of placed implants

Arm/Group Title	Astra Tech Fixture ST
Arm/Group Description	Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Measure Participants	19
Measure Implants	70
Number [Number of implants]	7

Adverse Events

Arm/Group Title	Astra Tech Fixture ST
Arm/Group Description	Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
All Cause Mortality
	Astra Tech Fixture ST
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Astra Tech Fixture ST
	Affected / at Risk (%)	# Events
Total	2/19 (10.5%)
Injury, poisoning and procedural complications
Drug overdose	1/19 (5.3%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory arrest	1/19 (5.3%)	1
Other (Not Including Serious) Adverse Events
	Astra Tech Fixture ST
	Affected / at Risk (%)	# Events
Total	0/19 (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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.