Sponsor study identifier
interventional
27
1 country
1
Study Start
January 10, 2022
Actual (reported)Primary Completion
May 20, 2022
Actual (reported)Study Completion
June 1, 2022
Actual (reported)Aim of the current study is to compare the efficacy of Low Level Laser, Botulinum toxin type A, and repositioning appliance in management of reduced temporomandibular joint disc.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2022
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2021
Actual (reported)January 10, 2022
Actual (reported)January 18, 2022
Actual (reported)May 20, 2022
Actual (reported)June 1, 2022
Actual (reported)Temporomandibular joint dysfunction
Using Helkimo Anamnestic Index that includes 5 items, each having 3 possible answers scored 0, 1 or 5. The 1st item assesses limitations in range of jaw movement \& is divided to 4 sections: maximum mouth opening, protrusion \& lateral shift. For mouth opening , value of \>40mm scores 0, 30-39mm scores 1 \& \<30mm scores 5. Protrusion \& lateral shifts score 0 if the measurement is ≥7mm, 1 if ranging between 4-6mm and 5 if it is \<4mm. These sections are added together to get a total that scores 0 if the sum of the 4 sections is 0, 1 if the subtotal is between 1-4 \& 5 if the subtotal is \>4. The 2nd item evaluates joint alterations that produce deviations, sounds and joint locks. The 3rd item evaluates pain when performing movements. The 4th item evaluates masticatory muscles pain. The 5th item evaluates pain on palpation in the prearticular area of TMJ. The 5 items are added and scored; 0: no TMJ involvement, 1-9: mild involvement, 10-19: moderate involvement \& 20-25: severe involvement
3 months
Pain level
This will be assessed using the visual analogue scale (VAS) with score ranges from 0 (lowest) to 10 (highest). Higher scores indicate greater pain levels.
3 months
Temporomandibular joint clinical evaluation
Magnetic Resonance Imaging (MRI) will be performed for all patients using a 3 Tesla MRI scanner with a head coil. Gradient T2 (T2\*) and proton-density (PD) weighted spin echo (SE) sequences will be carried out in closed and open mouth positions in the oblique sagittal plane. MRI is considered the gold standard (objective) in imaging the soft tissue components of the TMJ.
3 months
Patients will receive low-level laser therapy on the temporomandibular joint disc
Patients will receive Botulinum toxin type A injection into the lateral pterygoid muscle under Electromyography (EMG) guidance.
Faculty of Dentistry, Alexandria University
Alexandria, 21512, Egypt
Rady NA, Bahgat MM, Abdel-Hamid AM. Promising minimally invasive treatment modalities for symptomatic temporomandibular joint disc displacement with reduction: a randomized controlled clinical trial. BMC Oral Health. 2022 Dec 1;22(1):547. doi: 10.1186/s12903-022-02579-3.
Mariam M Bahgat, M.Sc
Faculty of Dentistry, Alexandria University, Egypt
Nermeen A Rady, PhD
Faculty of Dentistry, Alexandria University, Egypt
Ahmed M Abdelhamid, PhD
Faculty of Dentistry, Alexandria University, Egypt
27 participants (actual enrollment reported by the registry).
First Submitted
December 20, 2021
First Posted
January 18, 2022
Study Start
January 10, 2022
Actual (reported)Patients will receive hard maxillary anterior repositioning appliance.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 20, 2022
Actual (reported)Study Completion
June 1, 2022
Actual (reported)Last Updated
December 4, 2023
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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