Evolving Treatment Modalities for Management of Patients Suffering From Disc Displacement With Reduction

NCT ID: NCT05194488

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2022-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Temporomandibular Joint Disc Displacement, With Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low level laser therapy

Group Type EXPERIMENTAL

Low level laser therapy

Intervention Type DEVICE

Patients will receive low-level laser therapy on the temporomandibular joint disc

Botulinum toxin type A

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type DRUG

Patients will receive Botulinum toxin type A injection into the lateral pterygoid muscle under Electromyography (EMG) guidance.

Anterior repositioning appliance

Group Type ACTIVE_COMPARATOR

Anterior repositioning appliance

Intervention Type DEVICE

Patients will receive hard maxillary anterior repositioning appliance.

Interventions

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Low level laser therapy

Patients will receive low-level laser therapy on the temporomandibular joint disc

Intervention Type DEVICE

Botulinum toxin type A

Patients will receive Botulinum toxin type A injection into the lateral pterygoid muscle under Electromyography (EMG) guidance.

Intervention Type DRUG

Anterior repositioning appliance

Patients will receive hard maxillary anterior repositioning appliance.

Intervention Type DEVICE

Other Intervention Names

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LLLT Botox

Eligibility Criteria

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Inclusion Criteria

* TMJ with audible and palpable click.
* Patients with anterior disc displacement as detected by MRI.
* Presence of full or nearly full complement of natural teeth.

Exclusion Criteria

* Patients who have radiographic evidence of degenerative conditions of TMJ.
* Patients who have anterior disc dislocation without reduction.
* Previous history of TMD treatment.
* History of recent trauma.
* The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
* Inability or unwillingness to undergo magnetic resonance imaging (MRI) such as implanted electronic devices.
* Pregnant and lactating females.
* Patients with known allergy to botulinum toxin type A.
* Patients suffering from neurological disorders.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nourhan M.Aly

OTHER

Sponsor Role lead

Responsible Party

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Nourhan M.Aly

Assistant Lecturer of Dental Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mariam M Bahgat, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Alexandria University, Egypt

Nermeen A Rady, PhD

Role: STUDY_DIRECTOR

Faculty of Dentistry, Alexandria University, Egypt

Ahmed M Abdelhamid, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Alexandria University, Egypt

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 36456937 (View on PubMed)

Other Identifiers

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IRB 00010556

Identifier Type: -

Identifier Source: org_study_id