The primary objective of this study is to investigate the improvement of masticatory function of implant-supported RPD treatment in free-ending, bilateral mandibular partial edentulism. The secondary objectives include patient satisfaction (OHIP14…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
kauwstelsel, orale functie en comfort
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome variable is the masticatory function as reflected by the
so-called *mixing index* (MI). This parameter gives information about the
mastication ability of the patient by analyzing the degree of mixing of a
two-layered wax tablet after chewing (20 strokes).
Secondary outcome
Secondary outcome variables include patient satisfaction, clinical and
radiographical parameters.
Patient satisfaction is determined by means of validated questionnaires that
measures people*s perceptions of the social impact of oral disorders on their
well-being (OHIP-NL49) the health related quality of life (SF36), and a Visual
Analogue Scale (VAS) on general satisfaction with the function of their
prosthetic appliance (range 0-100).
Clinical and radiographical parameters include:
1.probing pocket depth (PPD)
2.recession (REC)
3.bleeding on probing (BOP) is assessed at 2 sites per implant (mid-buccal and
mesial). A plastic periodontal probe with 0.25 N of calibrated probing force is
used (Click-probe®, KerrHawe, Bioggio, Switzerland).
PPD is measured in millimetres from the mucosal margin to the clinical pocket.
REC is measured in millimetres from the edge of the Locator abutment to the
mucosal margin. BOP is noted as absent (score=0) or present (score=1). Mean
values per implant are calculated for all variables (meanPPD, meanREC and
meanBOP).
4.Detailed post-insertion maintenance and restorative complications and
revisions are reported by means of chart review. Mechanical complications are
analyzed (MAI).
5.Marginal bone levels (MBL) are determined from standardized, long cone
intraoral radiographs by measuring from the edge of the abutment to the
bone-to-implant contact, both mesially and distally. Implant Survival (IS),
defined as the presence of the implant at any moment of observation is also
noted.
Background summary
Free-ending mandibular removable partial dentures yield poor patient acceptance
and are generally considered uncomfortable by the patient. Problems caused by
the rotational movement of the denture become more frequent. Implants placed in
the posterior parts of the mandible can help overcome these problems. Fixed,
implant-supported non-removable restorations are not always feasible, both from
a surgical and from a financial point of view. As an alternative, implants can
also provide retention and support for a Removable Partial Denture (RPD).
There is a lack of evidence in the literature to demonstrate the effectiveness
of implant-supported RPD. Well-controlled clinical trials, to the best our
knowledge, have not been performed. For a selective population of patients,
implant-supported RPD*s may well be a viable treatment option that thus far has
not yet been fully explored.
Study objective
The primary objective of this study is to investigate the improvement of
masticatory function of implant-supported RPD treatment in free-ending,
bilateral mandibular partial edentulism. The secondary objectives include
patient satisfaction (OHIP14 and a Visual Analogue Scale), clinical and
radiographical parameters (peri-implant health, marginal bone loss) and the
required amount of maintenance.
Study design
a randomized cross-over trial
Intervention
Each subject will be treated with 2 implants in each posterior part of the
mandible. For each subject a new RPD in the mandible and a new full dental arch
prosthesis are made following a standard design. The RPD will subsequently be
supported by the two most anterior implants or the two most distal implants
using Locator abutments. After three months the loading conditons are changed.
Data (clinical tests, questionnaires) will be gathered during the study at four
time points:
1. Old RPD in situ/without RPD
2. New RPD
3. Fixated RPD on two implants
4. Fixated RPD on two other implants
Study burden and risks
Patients will benefit from this research because it is reasonable that their
complaints regarding their RPD will diminish after it is retained to the
locator abutments on the implants. Subsequently the costs for this treatment
will only partially be charged. The risks consist of some adverse events
related to the surgical procedure: pain and swelling. Patients are allowed to
use analgetics after surgery if needed (Ibuprofen 600mg or paracetamol/codein
500/10mg.
Implant loss is a complication which might occur, although the prognosis is
very good with nowadays techniques and materials. If so, a new implant can be
placed after 3 months.
The previously described adverse events and are inherent to implant placement.
There are no extra risks because of participating in this study. At the end of
this study de patient is about to decide which implants he or she wants to be
used to fixate the RPD.
Antonius Deusinglaan 1
9713 AV Groningen
NL
Antonius Deusinglaan 1
9713 AV Groningen
NL
Listed location countries
Age
Inclusion criteria
4.2 Inclusion criteria
Inclusion criteria in this study are as follows:
- The patient is >= 18 years of age;
-The bone volume distal from the most posterior abutment teeth should allow the
placement of implants with a minimum length of 8 mm and minimum diameter of 3.3 mm;
-The patient has complaints regarding his bilateral, free-ending RPD in the mandible and has a full denture in the maxilla
-The patient is capable of understanding and giving informed consent.
Exclusion criteria
-Medical and general contraindications for the surgical procedures;
-A history of local radiotherapy to the head and neck region;
-Previous implant loss
-Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;
-Decreased masticatory function due to physical disorders
-Active, uncontrolled periodontal pathology of the remaining dentition;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL36209.042.11 |
| OMON | NL-OMON25611 |