Severe Atrophy of the Edentulous Mandible Clinical Trial
Official title:
Patient Satisfaction With the Use of Three Different Systems as Retention for Implant Supported Mandibular Overdentures.
The aim of the study is:
1. To validate the Romanian translation of OHIP-EDENT (Oral Health Impact Profile in
Edentulous Adults), the short form of OHIP (Oral Health Impact Profile) developed by
Allen and Locker for edentulous adults. The OHIP questionnaire is an efficient
instrument for assessment of OHRQoL - Oral Health-Related Quality of Life.
2. To compare satisfaction of 69 fully mandibular edentulous patients rehabilitated with
implant-supported overdentures with three different types of retention: Retentive
Anchors, Magnets, Locator.
Fully edentulism can substantially affect oral and general health as well overall quality of
life and inappropriate treatment using classical prosthesis may impaired buccal function,
increase alveolar bone loss and also is often unsatisfactory for most patients.
Implant-retained dentures provide successful long-term outcomes, particularly when used to
rehabilitate the edentulous mandible (Assad et al. 2004; Chan et al. 1995; Davis et al.
1999). Results achievable with such prostheses are well known: the degree of stability,
chewing efficiency, and ultimately patient satisfaction exceeds the benefits obtained with
conventional denture treatment.
However few studies have addressed the perception of treatments outcomes by patients and is
critically important to determine whether there are meaningful differences based on the type
of retention used (Retentive Anchors, Magnets, Locator).
OHIP-EDENT (Oral Health Impact Profile in Edentulous Adults), the short form (19 items) of
OHIP (Oral Health Impact Profile) detects the impact of oral health in the quality of life
of patients who wear total prosthesis and include questions addressing masticatory capacity,
pleasure of eating, level of comfort and relationship problems.
This questionnaire is validated in several languages but still not available in Romanian.
Material and methods
1. Linguistic and cultural adaptation:
Because the OHIP EDENT had not previously been used in Romania, it was piloted to
assess the face and content validity within the target population. The OHIP EDENT was
linguistically and culturally adapted to our setting by using the back translation
technique (according to guidelines provided by Beaton et al. 2000) in order to maintain
cross-cultural equivalence. In this procedure, translations were independently made by
two bilingual persons, who then discussed and produced a consensus Romanian version (T1
and T2 produced T12), which was translated back into English by two professional
English translator (one native English) who had never seen the original version (BT1
and BT2 versions).
The conceptual equivalence between the original instruments and the back-translated
versions was supported by an expert committee (formed by 3 researchers: methodologist,
two experts on quality of life studies, and the four translators). The definitive
Romanian version was produced after the face and content validity results in the pilot
study had been approved by this committee.
2. Pilot study:
Ethical approval and specific written consent were obtained from the relevant
authorities before the pilot study were started.
The pilot study was conducted in a convenience sample (n=35) obtained from mandibular
edentulous patients who came to the Dental School, University of Medicine and Pharmacy
Bucharest, Romania and Concordia Dent Clinic, Bucharest. Participants were clinically
examined according to the WHO (World Health Organization) methodology and completed the
pilot OHIP EDENT.
The comprehensiveness of the instrument was tested by asking about difficulties in
understanding items or frequencies, in order to optimize the face and content validity
before the main study.
Reproducibility was evaluated by measuring test - retest reliability. Test-retest
reliability was calculated using intraclass correlation coefficient (ICC). The sample
of 35 respondents fully edentulous was interviewed two weeks after the first interview.
3. Main Study:
Patient satisfaction was assessed with the aid of OHIP-EDENT questionnaire validated initial
(with the original denture), after 6 months and at 1, 3, 5 years post overdenture insertion.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment