Back to resultsEffects of Different Treatment Modalities for Obstructive Sleep Apnea on Temporomandibular Joint
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
different treatment modalities for OSA
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, tempromandibular joint
Eligibility Criteria
Inclusion Criteria:
- • All adult patients, diagnosed as having OSA after full night polysomnography.
Exclusion Criteria:
- • Pregnant patients
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
three groups of different treatment modalities for OSA
Arm Description
Group I: patients were treated with CPAP. Group II: patients were treated with digitally fabricated MAD. Group iII: patients were treated with oral myofunctional therapy.
Outcomes
Primary Outcome Measures
This study aims to assess signs of temporomandibular disorders related to the use of CPAP, MAD and physical therapy in the treatment of patients with OSA.
Pain scoring will be measured through a visual analogue scale (VAS) with 0 scores for no pain and 10 scores for worst pain experien Clicking was assessed as to its presence=1 or absence=0 The maximal unassisted, pain-free mouth opening will be measured in millimeters using a Vernier caliper Lateral movements: will be measured as the horizontal distance extending from maxillary midline to mandibular midline in millimeters using Vernier caliper All measurements record will be considered as a baseline to be used in comparison with 3 months post-treatment records
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05510882
Brief Title
Effects of Different Treatment Modalities for Obstructive Sleep Apnea on Temporomandibular Joint
Official Title
Effects of Different Treatment Modalities for Obstructive Sleep Apnea on Temporomandibular Joint
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
this study aims to evaluate the subjective symptoms, clinical and radiographic signs of temporomandibular disorders related to the use of CPAP, MAD and physical therapy in the treatment of patients with obstructive sleep apnea.
Detailed Description
The study will be conducted on thirty-nine patients with OSA attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography in the period between July and September 2022. The patients will be divided equally into three therapy groups each compromise 13 patients:
Group I: patients will be treated with CPAP. Group II: patients will be treated with digitally fabricated MAD. Group II: patients will be treated with physical therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, tempromandibular joint
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
three groups of different treatment modalities for OSA
Arm Type
Other
Arm Description
Group I: patients were treated with CPAP. Group II: patients were treated with digitally fabricated MAD. Group iII: patients were treated with oral myofunctional therapy.
Intervention Type
Other
Intervention Name(s)
different treatment modalities for OSA
Other Intervention Name(s)
treatment
Intervention Description
Group I: patients will be treated with CPAP. Group II: patients will be treated with digitally fabricated MAD. Group II: patients will be treated with physical therapy.
Primary Outcome Measure Information:
Title
This study aims to assess signs of temporomandibular disorders related to the use of CPAP, MAD and physical therapy in the treatment of patients with OSA.
Description
Pain scoring will be measured through a visual analogue scale (VAS) with 0 scores for no pain and 10 scores for worst pain experien Clicking was assessed as to its presence=1 or absence=0 The maximal unassisted, pain-free mouth opening will be measured in millimeters using a Vernier caliper Lateral movements: will be measured as the horizontal distance extending from maxillary midline to mandibular midline in millimeters using Vernier caliper All measurements record will be considered as a baseline to be used in comparison with 3 months post-treatment records
Time Frame
up to four months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• All adult patients, diagnosed as having OSA after full night polysomnography.
Exclusion Criteria:
• Pregnant patients
Facility Information:
Facility Name
Mansoura University
City
Mansoura
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The study will be conducted on thirty-nine patients with OSA attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography in the period between July and September 2022.
Learn more about this trial
Effects of Different Treatment Modalities for Obstructive Sleep Apnea on Temporomandibular Joint
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