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.: PACTR201505001080998 Date of Approval: 22/03/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Patient's Satisfaction And Muscles Activity After Management Of TMD Patients Using CAD/CAM Versus Conventional Occlusal Splints
Official scientific title Patient's Satisfaction And Muscles Activity After Management Of TMD Patients Using CAD/CAM Versus Conventional Occlusal Splints (Randomized Clinical Trial)
Brief summary describing the background and objectives of the trial Pain, discomfort and disability associated with myofacial pain dysfunction can greatly affect a person¿s quality of life, as well as perpetuate a headache, commonly described by the patients as tension headache, or even cause a migraine[2, 3]. Occlusal splints are removable interocclusal appliances that are usually fabricated out of hard acrylic. The objectives of splint use in the treatment of temporomandibular disorders (TMD) and myofascial pain dysfunction (MPD) include: eliminating occlusal interferences, stabilizing tooth and joint relationships, passive stretching of the musculature to reduce abnormal muscle activity, decreasing parafunctional habits, protecting against tooth abrasion and decreasing joint loading[4, 5].The aim of this study is to evaluate the effect of CAD/CAM versus conventional occlusal splints on patient's satisfaction and muscles activity after management of TMD patient.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Oral Health,Temporomandibular disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 03/03/2016
Actual trial start date 03/03/2016
Anticipated date of last follow up 03/08/2016
Actual Last follow-up date 03/09/2016
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (varying block size) Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CAD\CAM occlusal splint CAD\CAM occlusal splint 3 months CAD\CAM occlusal splint for the treatment of TMD patients 15
Control Group conventional occlusal splints conventional occlusal splints 3 months conventional occlusal splints for the treatment of temporomandibular disorders 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Age 18-45 years. 2-Temporomandibular disorders according to the research diagnostic criteria for TMD (RDC/TMD). 3-Absence of prior occlusal splint therapy. 4-No usage of any medicine that can interfere with sleep or motor function. 5-Absence of substantial dental or periodontal disease with good oral hygiene. 6-No neurological disorders. 7-Be physically and psychologically able to tolerate procedures. 8-Be cooperative to return for follow-up, examinations and evaluation. 1.Patients with poor oral hygiene and motivation. Because poor oral hygiene can cause inflammation which induce pain that effect VAS reading. 2.Psychiatric problems or unrealistic expectations. Because they cannot able to tolerate procedures. 3.Presence of prior occlusal splint therapy. Because presence of prior occlusal splints may cause permanent overlay effects. 4.Usage of any medicine : that can interfere with sleep or motor function. 5.Completely edentulous patients. Because the occlusal splint needs teeth to retain. 18 Year(s) 45 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 04/10/2015 Ethics Committee, Faculty of Oral and Dental Medicine -Cairo University
Ethics Committee Address
Street address City Postal code Country
11 saraya almanil Cairo 320 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome patient satisfaction before treatment one month after treatment three months after treatment
Secondary Outcome muscle activity before treatment one month after treatment three months after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Oral and Dental Medicine, Cairo University 11 saraya alminal Cairo 320 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Prosthodontics department- Faculty of Oral and Dental Medicine, Cairo University- Egypt 11 saraya alminal Cairo 320 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faculty of Oral and Dental Medicine, Cairo University- Egypt 11 saraya alminal Cairo 320 Egypt
Prosthodontics department- Faculty of Oral and Dental Medicine, Cairo University- Egypt 11 saraya alminal Cairo 320 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Radhwan Al-Gabri radalgabri@yahoo.com 00201157889674 24 almanil
City Postal code Country Position/Affiliation
Cairo 320 Egypt PHD
Role Name Email Phone Street address
Public Enquiries Elkhadem Amr amr@yahoo.com 01001162401 almanial street
City Postal code Country Position/Affiliation
Cairo 312 Egypt Lecturer of Prosthodontics Faculty of Oral and Dental Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries amal kaddah amalkaddah@yahoo.com 00201122181818 alagoza street
City Postal code Country Position/Affiliation
Cairo 453 Egypt profesor of Prosthodontics Faculty of Oral and Dental Medicine Cairo University
REPORTING
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Changes to trial information