Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-25 @ 11:48 PM
Study NCT ID:
NCT01392456
Status:
COMPLETED
Last Update Posted:
2015-02-04
First Post:
2011-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation and Cross-Cultural Adaptation of the Romanian Version of Oral Health Impact Profile in Edentulous Adults
Sponsor:
Concordia Dent Srl
Organization:
Study Overview
Official Title:
Patient Satisfaction With the Use of Three Different Systems as Retention for Implant Supported Mandibular Overdentures.
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROM-OHIP-ED
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 316/03 & 507-207 | OTHER_GRANT | ITI (INTERNATIONAL TEAM FOR IMPLANTOLOGY) 316/03&507-207 | View |