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

NCT02957487 | Completed

• 1 other identifier: REK 2013/1446
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous Maxilla

Outcome Measures

Primary Outcomes (2)

• Intra-oral status

  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.

  3 years

• Condition of prosthesis and implants

  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.

  3 years

Secondary Outcomes (3)

• Implant bone level changes

  3 years

• Patient-reported satisfaction outcome

  5 years

• Patient-reported quality of life outcome

  5 years

Interventions

Denture supported by 3 dental implants DEVICE

Metal-reinforced denture without palatal coverage incorporating nylon rings retained by friction to Locator abutments fitted on top of dental implants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated in a private dental clinic in Drammen, Norway

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Tromso: lead

Study Sites (1)

Tannlege Arild Mo

Drammen, 3044, Norway

Location

Related Publications (1)

• Mo A, Hjortsjo C, Olsen-Bergem H, Jokstad A. Maxillary 3-implant removable prostheses without palatal coverage on Locator abutments - a case series. Clin Oral Implants Res. 2016 Oct;27(10):1193-1199. doi: 10.1111/clr.12724. Epub 2015 Nov 14.

  PMID: 26566604 BACKGROUND

Study Officials

• Asbjørn Jokstad, DDS, PhD

  UiT The Arctic University of Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: November 7, 2016
• Study Start: September 1, 2013
• Primary Completion: September 28, 2018
• Study Completion: September 28, 2018
• Last Updated: May 16, 2019

Record last verified: 2019-04

Locations

NO (1)