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The upperdenture on a bar or pushbuttons?


- candidate number14253
- NTR NumberNTR3813
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jan-2013
- Secondary IDsNL43293.042.13 ABR
- Public TitleThe upperdenture on a bar or pushbuttons?
- Scientific TitleA comparison between bar versus ball mesostructures in the maxilla to support an overdenture; 1-year results from a randomized controlled trial.
- ACRONYM
- hypothesisA ball mesostrucure is easier to clean and will give better results then a bar mesostructure. Also, the technical procedure is easier and will satisfy the clinician and patient more.
- Healt Condition(s) or Problem(s) studiedOverdenture, Maxilla, Locator, bar
- Inclusion criteriaAt least two years edentulous in the upper jaw problems with retention and stability of the conventional complete denture and/or unpleasant feeling due to extended palatal plate of the denture Patient is endentulous in the lower jaw.
- Exclusion criteria1. No history of preprosthetic surgery in the upper jaw;
2. No medical contraindications for surgery;
3. Patient does not smoke (or is willing to give up smoking six weeks before surgery);
4. No history of radiotherapy in the head and neck region.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2013
- planned closingdate1-sep-2015
- Target number of participants100
- InterventionsThe testgroup will get 4 implants with a ballmesostructure in combination with an overdenture in the maxilla.

The controlgroup will get 4 implants with a barmesostructure in combination with an overdenture in the maxilla.
- Primary outcomePeri-implant bone height changes.
- Secondary outcome1. Implant survival;
2. Overdenture survival;
3. The clinical condition of the peri-implant mucosa;
4. Masticatory efficiency and patient satisfaction.
- TimepointsProspective randomised controlled trial.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES G.C. Boven
- CONTACT for SCIENTIFIC QUERIES G.C. Boven
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryBackground of the study:
A number of edentulous patients experiences problems with a conventional complete upper denture. Lack of retention and stability and an increased gagging reflex is the main complaint of these patients. An overdenture on endosseous implants gives the opportunity to improve retention and stability of the prosthesis and reduce the coverage of the palate.

Objective of the study:
The aim of the study is comparison of two attachment systems with four dental implants and overdentures in the upper jaw for patients who experience problems with retention and stability of the upper denture.

Study design:
A prospective randomized controlled trial.

Study population:
Healthy persons aged 18 years or older.

Intervention:
The testgroup will get 4 implants with a ballmesostructure in combination with an overdenture in the maxilla. The controlgroup will get 4 implants with a barmesostructure in combination with an overdenture in the maxilla.

Primary study parameters/outcome of the study: Peri-implant bone height changes.

Secundary study parameters/outcome of the study: Implant survival, overdenture survival, the clinical condition of the peri-implant mucosa, masticatory efficiency and patient satisfaction.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
According to the literature, both treatmenst are common treatments for patients with complaints of retention and stability of the upper denture. So there is no additional risk for the patients participating in the study. The patients will get to additional appointments for check-up. The first 1 month after placement of the overdenture and the second 1 year after placement of the overdenture. During these visits, the clinical and radiological measurements, the chewing test and questionnaires regarding patient satisfaction can be completed.
- Main changes (audit trail)
- RECORD23-jan-2013 - 27-mrt-2014


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