Maxillary 3-implant Removable Prostheses Without Palatal Coverage on Locator Abutments
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|ClinicalTrials.gov Identifier: NCT02957487|
Recruitment Status : Completed
First Posted : November 6, 2016
Last Update Posted : May 16, 2019
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|
|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|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|
- 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
- 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.
- 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.
- 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
- Patient-reported satisfaction outcome [ Time Frame: 5 years ]A self-reported Denture Satisfaction Scale questionnaire (Allen et al. 2001).
- 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).
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): NCT02957487
|Tannlege Arild Mo|
|Drammen, Norway, 3044|
|Principal Investigator:||Asbjørn Jokstad, DDS, PhD||UiT The Arctic University of Norway|