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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05510882
Other study ID # not sponsered
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date August 5, 2022

Study information

Verified date August 2022
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date August 5, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - • All adult patients, diagnosed as having OSA after full night polysomnography. Exclusion Criteria: - • Pregnant patients

Study Design


Intervention

Other:
different treatment modalities for OSA
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.

Locations

Country Name City State
Egypt Mansoura University Mansoura

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 up to four months
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