NCT06894472

Brief Summary

This study examines the effect of electromyography biofeedback on masticatory muscles hyperactivity on patients with bruxism.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

March 19, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 26, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

March 19, 2025

Last Update Submit

March 19, 2025

Conditions

Bruxism

Outcome Measures

Primary Outcomes (1)

  • Assessment of Masseter Hyperactivity

    The assessment of Masseter muscle hyperactivity will be carried out by the digital palpating scale according to the following criteria: Grade Zero (0): when the muscle palpated and there is no pain or tenderness reported by the patient. Grade (1): Recorded if the patient response the palpation is uncomfortable (tenderness or soreness). Grade (2): is recorded if the patient experiences definite discomfort or pain. Grade (3): is recorded if the patient shows evasive action or eye tearing or verbalizes a desire not to have the area palpated again.

    4 weeks

Study Arms (2)

Electromyography biofeedback + Pharmacotherapy

EXPERIMENTAL

This group will be treated with electromyography biofeedback for one month with a frequency of 3 sessions/week in addition to the pharmacotherapy which prescribed by the dentist.

Other: Electromyography biofeedbackDrug: Pharmacotherapy

Pharmacotherapy

OTHER

This group will be treated only with the pharmacotherapy which prescribed by the dentist.

Drug: Pharmacotherapy

Interventions

Electromyography biofeedbackOTHER

Participants in the experimental group will receive surface electromyography (SEMG) feedback training, targeting the Masseter muscle, for 40 minutes per session according to the Evidence-Based practice since longer practice may become counterproductive due to fatigue and loss of focus. The frequency of the sessions will be 3 sessions/week for 4 weeks.

Electromyography biofeedback + Pharmacotherapy
PharmacotherapyDRUG

Pharmacotherapy will be received by all participants in the two groups in the form of multi relaxant (cyclobenzaprine) 10 MG twice daily for 4 weeks \& anti inflammatory (non steroidal anti-inflammatory drugs).

Electromyography biofeedback + PharmacotherapyPharmacotherapy

Eligibility Criteria

Age20 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Twenty adult subjects with definite mild to moderate bruxism examined by a dentist prior to the study.
  • Tenderness of masticatory muscles on palpation grade one and two according to the digital palpating scale
  • Mild to moderate myofascial pain around the temporomandibular joint causing discomfort in the morning.

You may not qualify if:

  • Took any Botox or PRP injection treatment for this condition for the last six months
  • Had any advanced periodontal disease.
  • Any intraoral fixed splints.
  • Pregnancy.
  • Under psychiatric care.
  • Parkinson
  • Have any visual or auditory impairment.
  • Any cervical posture abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr University for Science and Technology

Giza, Egypt

Location

MeSH Terms

Conditions

Bruxism

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Sara Abdullah mohamed elsamahy, PhD

    Lecturer

    PRINCIPAL INVESTIGATOR

  • Mohamed Farouk Abdel-Latif, PhD

    Lecturer

    PRINCIPAL INVESTIGATOR

  • Amal Ahmed Mohamed Morsi, PhD

    Lecturer

    PRINCIPAL INVESTIGATOR

  • Wafaa Atef Abd Allah, PhD

    Lecturer

    PRINCIPAL INVESTIGATOR

  • Myassar Ayman Amine, M.Sc

    Ass. Lecturer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Abdullah mohamed elsamahy, PhD

CONTACT

+20 11 51401438Saraaelsamahy@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2025

First Posted

March 25, 2025

Study Start

March 26, 2025

Primary Completion

April 26, 2025

Study Completion

May 1, 2025

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations

EG(1)