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Maxillary 3-implant Removable Prostheses Without Palatal Coverage on Locator Abutments

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. Read our disclaimer for details. Identifier: NCT02957487
Recruitment Status : Completed
First Posted : November 6, 2016
Last Update Posted : May 16, 2019
Information provided by (Responsible Party):
University of Tromso

Brief Summary:

The aims of this clinical study conducted at a dental specialty clinic in Drammen, Norway are to assess the clinical outcomes of patients with an edentate upper jaw having been treated with a removable full prosthesis supported by 3 implants to restore function and aesthetics. Clinical variables beyond implant dimensions and intraoral location, such as recall routines, maintenance needs, patient satisfaction and quality of life, will also be appraised and contrasted with an aim to elucidate their association with clinical outcomes. Specific evaluation will be done with regard to the following outcome criteria:

  • crestal bone levels and periodontal conditions around implants
  • incidence rates of biological, technical, traumatic failures / complications related to implants
  • incidence rates of biological, technical, mechanical, esthetic failures/complications with prosthesis and prosthetic components A secondary objective is to identify the different risk factors for biological failures / complications, including the influence of medical conditions and tobacco use.

Condition or disease Intervention/treatment
Edentulous Maxilla Device: Denture supported by 3 dental implants

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maxillary 3-implant Removable Prostheses Without Palatal Coverage on Locator Abutments - a Prospective Cohort Study
Actual Study Start Date : September 2013
Actual Primary Completion Date : September 28, 2018
Actual Study Completion Date : September 28, 2018

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Denture supported by 3 dental implants
    Metal-reinforced denture without palatal coverage incorporating nylon rings retained by friction to Locator abutments fitted on top of dental implants

Primary Outcome Measures :
  1. Intra-oral status [ Time Frame: 3 years ]
    The radiographic examination will comprise periapical radiographs or an orthopantomogram. The clinical examination include a basic periodontal examination with the use of an UNC-15 (University of North Carolina) manual periodontal probe. Outcomes measured will be presence or absence of peri-implant suppuration or fistula, the modified plaque and sulcus bleeding indices) and the probing depths.

  2. Condition of prosthesis and implants [ Time Frame: 3 years ]
    The removable prosthesis will be examined for any technical flaws. Adverse technical events include loss of retention, or fracture and/or chipping of the removable prosthesis. Adverse mechanical events include loosening of the male attachment or fracture of an implant. The stability of all implants will be assessed, and any sign of mobility along with pain and discomfort will be interpreted as a definitive sign of implant failure.

Secondary Outcome Measures :
  1. Implant bone level changes [ Time Frame: 3 years ]
    Reference bone levels on the mesial and distal sides will be measured relative to baseline measurements made at the time of delivery of denture

  2. Patient-reported satisfaction outcome [ Time Frame: 5 years ]
    A self-reported Denture Satisfaction Scale questionnaire (Allen et al. 2001).

  3. Patient-reported quality of life outcome [ Time Frame: 5 years ]
    The short form version of the Oral Health Impact Profile questionnaire (OHIP-20) (Allen & Locker 2002).

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated in a private dental clinic in Drammen, Norway

Inclusion Criteria:

Edentulous maxilla Competence to sign the informed consent form describing the study

Exclusion Criteria:

Lack of jaw bone for the placement of dental implants without the need for bone regeneration.

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 identifier (NCT number): NCT02957487

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Tannlege Arild Mo
Drammen, Norway, 3044
Sponsors and Collaborators
University of Tromso
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Principal Investigator: Asbjørn Jokstad, DDS, PhD UiT The Arctic University of Norway
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Responsible Party: University of Tromso Identifier: NCT02957487    
Other Study ID Numbers: REK 2013/1446
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases