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Two or four implants as a support for an overdenture in the upper jaw.


- candidate number27953
- NTR NumberNTR6742
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-sep-2017
- Secondary IDsvolgt volgt
- Public TitleTwo or four implants as a support for an overdenture in the upper jaw.
- Scientific TitleA comparison between two and four implants in the edentulous maxilla to support an overdenture; 1-year results from a randomized controlled trial.
- ACRONYM
- hypothesisAn overdenture supported by two implants doesn't show more peri-implant bone loss after one year than an overdenture supported by four implants.
- Healt Condition(s) or Problem(s) studiedOverdenture, Maxilla, Implant
- Inclusion criteria1. At least one year edentulous in the upper jaw
2. problems with retention and stability of the conventional complete denture and/or unpleasant feeling due to extended palatal plate of the denture
3. Patient is endentulous in the lower jaw.
- Exclusion criteria1. history of preprosthetic surgery in the upper jaw;
2. medical contraindications for surgery;
3. smoking (or isn't willing to give up smoking six weeks before surgery);
4. history of radiotherapy in the head and neck region.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2017
- planned closingdate1-dec-2021
- Target number of participants50
- InterventionsThe testgroup will get 2 implants with a barmesostructure 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.
5. Overall health
- TimepointsProspective randomised controlled trial.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES P. Onclin
- CONTACT for SCIENTIFIC QUERIES P. Onclin
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryBackground
A numer of edentulous pat´ents experience problems with a conventional complete upper denture. Lack of retention and stability and an increased gagging reflex are the main complaints 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
The aim of the present study is to compare overdentures that are supported by two and four implants, 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 2 implants with a barmesostructure 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, patient satisfaction and overall health impact

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
According to the literature, treating patients with an overdenture in the maxilla on four implants is the standard treatment. Treating patients with two implants gives similar or less risk, because less implants are placed compared to standard treatment.

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)
- RECORD26-sep-2017 - 21-okt-2017


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