Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201804003264155 Date of Approval: 29/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Physiotherapy for Temporomandibular joint dysfunction (TMD)
Official scientific title The Effect of a short term Conservative Physiotherapy Treatment versus Occlusive Splint on Pain and ROM in Cases of Myogenic TMJ Dysfunction. A randomized controlled trial
Brief summary describing the background and objectives of the trial The number of patients suffering from temporomandibular joint dysfunction (TMD) has been increased dramatically. It has been reported that 8 out of 10 patients seek a health care practitioner-mainly a dentist- complaining of symptoms that are diagnosed as bruxism or TMD. Physical Therapy treatments are non-invasive interventions including (Therapeutic exercises, manual therapy, electro-physical modalities, and electro-analgesic modalities) and manual therapy (MT) including (TMJ mobilization, manipulation, or treating the surrounding soft tissues. The objective Physiotherapy approaches is to reduce pain, improve strength, mobility, coordination and proprioception, ROM, breakdown adhesion, and to stimulate the production of synovial fluid. On the other hand, therapy with an occlusal splint is commonly used as a basic dental treatment. Occlusal splints have been reported to alter afferent activity from intra-oral tissues by providing pressure on intra-oral tissues and covering teeth. As splint therapy is not specific, still the mechanisms underlying its effectiveness are not well understood. Meanwhile, the quality of the underlying evidence for physiotherapy studies is not certain and low. Therefore, the purpose of this study was to deliver a new randomized control trial to compare the effects of a short term conservative physiotherapy treatment program versus occlusive splints on pain and range of motion (ROM) in cases of TMJ Dysfunction
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TMD
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Oral Health,TMD
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 29/03/2018
Actual trial start date 15/04/2018
Anticipated date of last follow up 10/05/2018
Actual Last follow-up date 10/05/2018
Anticipated target sample size (number of participants) 112
Actual target sample size (number of participants) 112
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 randomization with variable block size Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization with variable block size Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization with variable block size Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization with variable block size Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Physiotherapy twice weekly 6 weeks Physiotherapy treatment will be delivered for 15 min per session, two times per week for 6 weeks . The treatment plan included: a. Relaxed Jaw position: Place the tongue lightly on the top of the mouth behind the upper front teeth, allowing the teeth to come apart and relaxing the jaw muscles. b. Stretching: ¿ Masseter Stretch Starts with a closed mouth and relaxing the jaw as much as possible 56
Control Group Occlusive spint daily 6 weeks Regular occlusive splint 56 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
TMJ myogenic dysfunctions, bruxism, Masticatory muscles shortening. TMJ arthritis, TMJ surgery 18 Year(s) 40 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 14/01/2018 REC - Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
7- Ahmed alzayat st. Ben al sarayat, Dokki Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain VAS 2 intervals. Pretreatment and post after 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy, Cairo University 7 Ahmed elziat st. Ben elsarayat, Dokki Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of physical Therapy ,Cairo University Ahmed alzayat, Dokki Giza 12612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tamer Shousha 40 Mohamed farid st, 6 of October city Egypt University
COLLABORATORS
Name Street address City Postal code Country
Al-Sadat Saad 7 Ahmed alzayat st Giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tamer Shousha shoushadoc@yahoo.com 01227900667 7 ahmed alzayat st
City Postal code Country Position/Affiliation
Giza 12612 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Tamer Shousha shoushadoc@yahoo.com 01227900667 7 ahmed alzayat st.
City Postal code Country Position/Affiliation
Giza 12612 Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Elsadat Sadaat sadatsaad@yahoo.com 01129893636 7 ahmed alzayat st
City Postal code Country Position/Affiliation
Giza 12612 Egypt Lecturer
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information