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Implant Overdenture Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03272828
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Mats Kronstrom, University of Washington

Brief Summary:
The purpose of the study is to compare two different types of dental implants which will be used to support/retain a removable denture in the edentulous mandible. Subjects will have one implant placed in the midline of the mandible after which the patient's existing denture will be modified to fit the implant. The population of this study consists of healthy edentulous individuals 20-75 years of age who have complete dentures in the upper and lower arch.

Condition or disease Intervention/treatment Phase
Dental Implants Device: Nobel Biocare titanium dental implants Not Applicable

Detailed Description:
Titanium dental implants have been frequently used in the rehabilitation of edentulous patients. Implants may provide adequate denture stability, improve oral function and oral health related quality of life. There is evidence that implants supporting fixed and removable prostheses have excellent long term success rates. Factors such as implant surface characteristics, length, diameter and shape (parallel sided or tapered) may play and important role for the outcome of the treatment especially when the immediate loading protocol (loading of the implant the same day it is surgically placed) is utilized. There are reports indicating that dental implants placed according to the immediate loading protocol can be used to support removable prostheses in the mandible. Such protocol would minimize the number of surgical procedures and significantly shorten the overall treatment time. Further, increased oral health related quality of life has been reported from studies on mandibular implant overdentures. Traditionally two implants have been suggested for the support of a mandibular overdenture. However, high patient satisfaction rates and appropriate denture retention have been reported among patients with a single implant placed in the mid-line. It is also important to further evaluate and compare various implant designs to determine clinical outcomes. The two dominating types of implant body design on the market are the parallel-sided (straight) and the tapered (conical) shaped. Both implants have similar threads, and the surgical procedure for placing the implants in the bone tissue is similar, but the drills used have a slightly different design and shape. There are today no randomized controlled studies evaluating differences in outcomes with respect to the external implant design i.e. parallel sided or tapered.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study on the Immediate Loading of Mandibular Overdentures Supported by Parallel Sided or Tapered Dental Titanium Implants
Actual Study Start Date : June 15, 2012
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Active Comparator: Parallel sided implant Group
A Parallel sided titanium dental implant will be placed in the edentulous mandible. Outcomes between the groups will be compared
Device: Nobel Biocare titanium dental implants
See above

Active Comparator: Tapered shaped implant Group
A tapered shaped titanium dental implant will be placed in the edentulous mandible. Outcomes between the groups will be compared.
Device: Nobel Biocare titanium dental implants
See above




Primary Outcome Measures :
  1. Differences in success rate between the two types of dental implants studied [ Time Frame: 1-5 years ]
    Evaluating successful healing and long term outcomes



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be between 20 and 75 years of age
  • Be edentulous and have both upper and lower complete dentures
  • Present with ASA I or ASA II and no medical contraindications to implant treatment
  • Have adequate bone volume for placement of one (1) 4.0 mm diameter titanium dental implant with a minimum length of 10 mm in the symphyseal area (=midline) of the anterior mandible
  • Show absence of pathology such as cysts, infections in the gum tissue or bone and remaining roots.
  • Be able to understand the procedures and have a jaw opening range of 30 mm or more

Exclusion Criteria:

  • Ongoing chemotherapy
  • Previous radiation to head/neck
  • Ongoing corticosteroid medication
  • Ongoing blood thinner medication
  • Ongoing medication with psychopharmacological drugs
  • History of alcohol/drug abuse
  • Remaining teeth/root tips
  • Poor quality /fractured/severely worn dentures that cannot be modified to fit the implant
  • Jaw opening range less than 30 mm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272828


Contacts
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Contact: Mats Kronstrom, DDS, Ph.D 4258777345 mk33@uw.edu
Contact: Mary Kathlees Hagstrom, RDA 206-685-8132 mkh8@uw.edu

Locations
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United States, Washington
the Regional Research Clinic, School of Dentistry at the University of Washington Recruiting
Seattle, Washington, United States, 98025
Contact: Mats Kronstrom, DDS, Ph.D    425-877-7345    mk33@uw.edu   
Contact: Mary Kathleen Hagstrom, RDA    206-685-8132    mkh8@uw.edu   
Sponsors and Collaborators
University of Washington
Publications:
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Responsible Party: Mats Kronstrom, Professor, Department of Restorative Dentistry, University of Washington
ClinicalTrials.gov Identifier: NCT03272828    
Other Study ID Numbers: STUDY00003063
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No