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.: PACTR201707002363250 Date of Registration: 19/06/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Patient Satisfaction of Metallic versus Injectable Thermoplastic Resin Obturator Frameworks in Maxillectomy Patients (A Cross over Randomized Clinical
Official scientific title Patient Satisfaction of Metallic versus Injectable Thermoplastic Resin Obturator Frameworks in Maxillectomy Patients (A Cross over Randomized Clinical Trial)
Brief summary describing the background and objectives of the trial To compare between the maxillary definitive obturator frameworks made from injectable thermoplastic resin versus the conventional metal maxillary obturator framework from the points of patients satisfaction and comfort and also bone loss around the abutment teeth in the intact side.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Patient satisfaction for maxillary obturator
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 03/01/2015
Actual trial start date 06/06/2015
Anticipated date of last follow up 30/06/2016
Actual Last follow-up date 28/12/2017
Anticipated target sample size (number of participants) 16
Actual target sample size (number of participants) 12
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
28810310100355 Ahmad Abdel Salam Hussein
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
Crossover: all participants receive all interventions in different sequence during study Randomised computer-generated two column tables of random numbers using www.random.org Central randomisation by phone/fax Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Maxillary obturator with thermoplastic acetal framework 6 months Maxillary obturator with thermoplastic acetal framework 8
Control Group Maxillary obturator with conventiona metallic frameworks 6 months Maxillary obturator with conventiona metallic frameworks 8
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Dentulous hemimaxillectomy patients with most of the natural teeth are remaining in the intact side of maxilla - The Remaining maxillary teeth should be sound or restored if carious and with good periodontal conditions - The Patients should be systemically free - Patients with good oral hygiene - The patients should have accepted mouth opening - The patients should be co-operative - Edentulous hemimaxillectomy patients - Patients with recent surgical intervention in the maxilla (within at least one year) - Patients subjected to radiotherapy - Patients with few and/or badly decayed remaining maxillary teeth in the intact side - Patients having mobile remaining maxillary teeth and/or with bad periodontal conditions - Patients with xerostomia - Patients with serious systemic problem or condition 20 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
Yes 27/01/2015 Research Ethics Committee Cairo University Faculty of Oral and Dental Medicine
Ethics Committee Address
Street address City Postal code Country
11 Al Saraya, Al Manial Cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Patient satisfaction 1- Zero point 2- 3 months 3- 6 months
Secondary Outcome Bone height 1- zero time 2- 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Clinic of Removable Prosthodontics Department-Faculty of Oral and Dental Medicine-Cairo University 11 Al Saraya, Al Manial Cairo Egypt
The Outpatient Clinic of the ENT Department, Faculty of Medicine, Cairo University ¿Al manial Cairo Egypt
The Oral and Maxillofacila Surgerys Department, National Cancer Institute, Cairo University Al Kasr Al Aini, Fom Al Khalig WA Deir an Nahas, Misr Al Qadimah Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmad Abdel Salam Hussein (self funded) 3 sayed metwaly street, Al Basatein Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmad Abdel Salam Hussein 3 sayed metwaly street, Al Basatein Cairo Egypt University
Secondary Sponsor Cecile George Nasr city Cairo Egypt University
Secondary Sponsor Iman Abdel-Wahab Radi Garden city Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Ahmed Abdel Hameed Sheikh zayed City Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdel Salam Hussein a.abdessalam_10@yahoo.com 01158977888 3 sayed metwally street, El Basateen
City Postal code Country Position/Affiliation
Cairo Egypt Dentist at Cairo university students hospital
Role Name Email Phone Street address
Public Enquiries Ahmed Abdel Salam Hussein a.abdessalam_10@yahoo.com 01158977888 3 sayed metwally street, El Basateen
City Postal code Country Position/Affiliation
Cairo Egypt Dentist at Cairo university students hospital
Role Name Email Phone Street address
Scientific Enquiries Iman Abdel Wahab Radi iman.abdelwahab@dentistry.cu.edu.eg 01001539613 Kasr el einy street, Garden city
City Postal code Country Position/Affiliation
Cairo Egypt Professor of removable prosthodontics, faculty of dentistry, Cairo university
REPORTING
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