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A Randomized Prospective Clinical Trial Comparing Single Tooth Implant 3 Loading Protocols

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ClinicalTrials.gov Identifier: NCT00607022
Recruitment Status : Completed
First Posted : February 5, 2008
Results First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Collaborator:
Dentsply Sirona Implants
Information provided by (Responsible Party):
Clark Stanford, University of Iowa

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Health Services Research
Condition: Dental Implant
Intervention: Device: dental implant

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Immediate Load

immediate load of dental implant based on the bone quality determined by the insertion torque value

dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.

6 Week Load

delayed load (6 weeks post surgery) of dental implants based on bone quality determined by the insertion torque value

dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.

12 Week Load

traditional loading of dental implants (12 weeks post surgery) based on bone quality determined by the insertin torque value.

dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.


Participant Flow:   Overall Study
    Immediate Load   6 Week Load   12 Week Load
STARTED   7   15   19 
COMPLETED   6   15   19 
NOT COMPLETED   1   0   0 
Withdrawal by Subject                1                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Immediate Load

immediate load of dental implant based on the bone quality determined by the insertion torque value

dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.

6 Week Load

delayed load (6 weeks post surgery) of dental implants based on bone quality determined by the insertion torque value

dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.

12 Week Load

traditional loading of dental implants (12 weeks post surgery) based on bone quality determined by the insertin torque value.

dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.

Total Total of all reporting groups

Baseline Measures
   Immediate Load   6 Week Load   12 Week Load   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   15   19   41 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      7 100.0%      15 100.0%      19 100.0%      41 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 34  (7)   35  (8)   34  (5)   34  (7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      5  71.4%      10  66.7%      10  52.6%      25  61.0% 
Male      2  28.6%      5  33.3%      9  47.4%      16  39.0% 
Region of Enrollment 
[Units: Participants]
       
United States   7   15   19   41 


  Outcome Measures

1.  Primary:   Implant Stability Scale (ISQ) Score Change After 16 Weeks   [ Time Frame: 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  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.


Results Point of Contact:  
Name/Title: Clark Stanford
Organization: University of Iowa
phone: 319-335-7381
e-mail: CStanford@uiowa.edu



Responsible Party: Clark Stanford, University of Iowa
ClinicalTrials.gov Identifier: NCT00607022     History of Changes
Other Study ID Numbers: 200710722
First Submitted: January 22, 2008
First Posted: February 5, 2008
Results First Submitted: July 6, 2017
Results First Posted: July 27, 2018
Last Update Posted: July 27, 2018