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.: PACTR201806003371275 Date of Approval: 04/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title CAD CAM Oral Appliances for Treatment of Obstructive Sleep apnea Hypopnea Syndrome
Official scientific title Efficacy of Two CAD CAM Oral Appliances for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome (Randomized Controlled Clinical Trial)
Brief summary describing the background and objectives of the trial Background: Obstructive sleep apnea (OSA) is a condition in which there is repetitive and intermittent occlusion of the upper airway during sleep. If repetitive apnea occurs in a patient, many times a night, for years together, there will be considerable changes in the nervous system, myocardial and cerebral circulation, pulmonary and systemic circulation. Treatment for OSA can be; continuous positive airway pressure (CPAP), surgery, or oral appliances. Mandibular Advancement Appliance (MAA) is considered a valid alternative, which can be the first choice in simple snorers, mild OSA patients, mild-moderate OSA. MAA can be either customed or non-customed, one-piece or two-pieces, titratable or non-titratable. While Monoblock designs permit no mouth opening, Two-piece appliances vary in permissible lateral jaw movement and in the coupling mechanisms which attach the two plates together. The use of rigid mandibular advancement appliance restricts mandibular movement and this immobility sometimes produces discomfort, including temporomandibular disorders. The aim of the study is to assess the influence of a new design of two pieces (Biblock) mandibular advancement appliance (MAA) fabricated by CAD/CAM additive manufacturing for treatment of obstructive sleep apnea hypopnea syndrome and to compare the influence of Biblock with Monoblock MAA design to improve the patient's sleep quality by reducing or eliminating snoring and respiratory pauses during sleep.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstructive Sleep Apnea Hypopnea Syndrome,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/05/2018
Actual trial start date 15/05/2018
Anticipated date of last follow up 15/05/2019
Actual Last follow-up date 15/05/2019
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Not yet 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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomi sation (variable block size) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Biblock 6 months Biblock Mandibular Advancement Appliances 10
Experimental Group Monoblock 6 months Monoblock Mandibular Advancement Appliances 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients had successfully completed all night polysomnography that demonstrate an OSA disorder. Each patient had an apneic hypopneic index (AHI) score greater than or equal to 15 events per hour of sleep. All patients had adequate nasal airflow capacity as determined by a qualified otolarygologist. All patients had at least 7 mm of protrusive jaw movement from the position of maximum intercuspation. (measured by flexible ruler) Central sleep apnea events more than two or three per hour. Retro-palatal obstructions as confirmed by nasoendoscopy. More than one missing tooth per quadrant, excluding third molars (fixed bridges were not considered missing). History of alcohol or narcotic or psychoactive medications. Serious nasal passage obstructions or allergies. 18 Year(s) 50 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 30/11/2017 IRB: Faculty of Dentistry, Alexandria University
Ethics Committee Address
Street address City Postal code Country
Champollion Street, Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Overnight polysomnography three months, Six months after intervention
Primary Outcome change in the airway space using cone-beam computed tomography (CBCT) three months, Six months intervention
Secondary Outcome Results of STOP-Bang Questionnaire and USE-OA Questionnaire three months, Six months after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Prosthodontics Faculty of Dentistry Alexandria University Champollion St., Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Dentistry, Alexandria University. Champollion St., Azarita Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Dentistry, Alexandria University. Champollion St., Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mervat Elsayed Abdallah Champollion St., Azarita Alexandria 21521 Egypt
Faten Salah Eldin Champollion St., Azarita Alexandria 21521 Egypt
Mohamed Moataz Khamis Abdel Razek Champollion St., Azarita Alexandria 21521 Egypt
Nashwa Hassan Abdel Wahab Champollion St., Azarita Alexandria 21521 Egypt
Amr Mohamed Ekram Champollion St., Azarita Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faten Salah Eldin faten_salah@hotmail.com 01155252515 Champollion St., Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Prosthodontics, Faculty of Dentistry, Alexandria University  
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Mohamed Moataz Khamis moataz_khamis@yahoo.com 01001634254 Champollion St., Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Prosthodontics, Faculty of Dentistry, Alexandria University
REPORTING
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