Validation and Cross-Cultural Adaptation of the Romanian Version of Oral Health Impact Profile in Edentulous Adults
Validation and Cross-Cultural Adaptation of the Romanian Version of Oral Health Impact Profile in Edentulous Adults
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.
Inclusion Criteria:

 -  Fully mandibular edentulous patients

 -  Complains about the stability of the existing mandibular denture satisfactory from a
 technical point of view.

 -  Acceptance of a mandibular over-denture retained by two endosseous implants.

 -  Patients agree to a 5-year follow-up period.

 Exclusion Criteria:

 -  Insufficient bone volume (height and with) for inserting at least a 10 mm implant (Ø
 4,1).

 -  Angle class II relationship.

 -  Physical severe consideration that will affect the minimal invasive surgical procedure
 or constitute a hindrance for a 5-year follow-up.

 -  History of radiotherapy in the head and neck region.

 -  History of pre-prosthetic surgery (including bone graft procedures) or previous oral
 implants.