The Use of Low-Dose Botulinum Toxin Injection Into the Masseter Muscle to Treat Sleep Bruxism

NACompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

March 15, 2021

Primary Completion Date

September 15, 2021

Study Completion Date

February 10, 2022

Conditions
Nocturnal Bruxism
Interventions
DRUG

BOTOX® Injection

100 MU of botulinum toxin type A (BOTOX® - Allergan Inc. - Dublin - Ireland) were diluted in 2ml of saline. Patients were injected with 10 MU of BTXA per side at two sites into the masseter muscle bilaterally. The first site was the inferior prominent part of the masseter muscle observed when the subject was asked to clench, and the other site was 5 mm below the first point

OTHER

Prick skin

patients were pricked twice at the inferior prominent part of the masseter muscle observed using the stinger pen used in the blood glucose meter; it is less painful and provides psychological benefits, instead of injecting the physiological saline into the muscle to avoid the severe pain without a benefit to the patient which would not conform to the ethical standards.

Trial Locations (1)

Unknown

University of Damascus, Damascus

All Listed Sponsors
lead

Damascus University

OTHER

NCT05620316 - The Use of Low-Dose Botulinum Toxin Injection Into the Masseter Muscle to Treat Sleep Bruxism | Biotech Hunter | Biotech Hunter