Ignite Creation Date:
2024-05-05 @ 11:43 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01392456
Status:
COMPLETED
Last Update Posted:
2015-02-04
First Post:
2011-07-11
Brief Title:
Validation and Cross-Cultural Adaptation of the Romanian Version of Oral Health Impact Profile in Edentulous Adults
Sponsor:
Concordia Dent Srl
Organization:
Concordia Dent Srl
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 n35 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 n35 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 31603 507-207 | OTHER_GRANT | ITI INTERNATIONAL TEAM FOR IMPLANTOLOGY 31603507-207 | None |