Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201510001278802 Date of Approval: 26/09/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Validation and Cross-Cultural Adaptation of the Egyptian Version of Oral Health Impact Profile in Edentulous Adults (OHIP-EDENT EGYPT)
Official scientific title Validation and Cross-Cultural Adaptation of the Egyptian Version of Oral Health Impact Profile in Edentulous Adults (OHIP-EDENT EGYPT)
Brief summary describing the background and objectives of the trial The Oral Health Impact Profile (OHIP-EDENT) is a 19-items questionnaire designed to measure self-reported functional limitation, discomfort and disability attributed to oral conditions[1]. The OHIP-EDENT is a self-filled questionnaire that focuses on seven dimensions of impact (functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability and handicap) with participants being asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score2), fairly often (score 3) and very often (score 4) using a twelve-months recall period[2]. The aim of the study is: To validate the Egyptian 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.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied completely edentuolus patients,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 30/09/2015
Actual trial start date 30/09/2015
Anticipated date of last follow up 01/02/2016
Actual Last follow-up date 01/02/2016
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group patients with conventional complete dentures conventional complete dentures 3 months conventional complete dentures 50 Active-Treatment of Control Group
Experimental Group patients with implant supported overdenture implant supported overdenture 3 months implant supported overdenture 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age: 21 Years and older both genders Fully mandibular edentulous patients or patients with implants overdenture cooperative patients good oral health high mental attitude uncooperative patients mentally retarded patients 21 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 30/09/2015 ethics committee of faculty of dentistry Cairo university
Ethics Committee Address
Street address City Postal code Country
11 sarayia almanil Cairo 311 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To validate the Egyptian translation of OHIP-EDENT (Oral Health Impact Profile in Edentulous Adults) at baseline after 1 month and at the end of 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
prosthodontic department Cairo university 11 saraya almanil Cairo 311 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding ali shraef Cairo 370 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Cairo university 11 saraya almanil Cairo 311 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ibb university almaleka arwa street IBB 124 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ahmed alqutaibi am01012002@gmail.com 00201144772955 ali sharef
City Postal code Country Position/Affiliation
Cairo 370 Egypt resistant lecturer prosthodontic department Ibb unversity
Role Name Email Phone Street address
Public Enquiries Radhwan Algabri radalgabri@yahoo.com 00201157889674 radwan street almanil
City Postal code Country Position/Affiliation
Cairo 385 Egypt lecturer prosthodontic department Ibb unversity
Role Name Email Phone Street address
Scientific Enquiries Amal Kaddah amalkaddah@yahoo.com 0020111181818 alagosa
City Postal code Country Position/Affiliation
Cairo 612 Egypt professor of prosthodontic Cairo university
REPORTING
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Changes to trial information