Effects of Different Treatment Modalities for Obstructive Sleep Apnea on Temporomandibular Joint
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 5, 2022
CompletedFirst Submitted
Initial submission to the registry
August 8, 2022
CompletedFirst Posted
Study publicly available on registry
August 22, 2022
CompletedApril 11, 2023
August 1, 2022
1 month
August 8, 2022
April 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
three groups of different treatment modalities for OSA
OTHERGroup I: patients were treated with CPAP. Group II: patients were treated with digitally fabricated MAD. Group iII: patients were treated with oral myofunctional therapy.
Interventions
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.
Eligibility Criteria
You may qualify if:
- All adult patients, diagnosed as having OSA after full night polysomnography.
You may not qualify if:
- Pregnant patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University
Al Mansurah, Egypt
Related Publications (1)
Attia AAMM, Awad SS, Mansour M, Baz H, Zahran KM, Saleh AM. Effects of different treatments for obstructive sleep apnea on temporomandibular joint: a randomized clinical trial. BMC Oral Health. 2024 Aug 11;24(1):931. doi: 10.1186/s12903-024-04623-w.
PMID: 39129005DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2022
First Posted
August 22, 2022
Study Start
July 1, 2022
Primary Completion
August 1, 2022
Study Completion
August 5, 2022
Last Updated
April 11, 2023
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share
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.