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

NCT05620316 | Completed DMC

• 1 other identifier: UDDS-OMFS-02-2022
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Botulinum toxin (BOTOX®) injections into the masseter muscle are an effective treatment for nocturnal bruxism, with several trials using various dosages of botulinum toxin for this purpose. The aim was to evaluate the effectiveness of injecting 10MU of botulinum toxin A (BTXA) into the masseter muscle to reduce nocturnal bruxism, the sample will randomly divided into 2 groups. In the injection group, Patients will inject with 10 MU of botulinum toxin type A (BOTOX® - Allergan Inc. - Dublin - Ireland) per side at two sites into the masseter muscle bilaterally. In this Placebo group, patients will prick twice at the inferior prominent part of the masseter muscle observed using the stinger pen used in the blood glucose meter. The evaluation will make by Electromyography (EMG) analysis, Visual Analogue Scale (VAS) values.

Conditions

Nocturnal Bruxism

Keywords

Nocturnal bruxism; Botulinum toxin; Masseter muscle; Electromyography

Outcome Measures

Primary Outcomes (2)

• Change in the electromyographic recorded values

  EMG signals will record with Matrix EP Light EMG (Micromed, Via Giotto, Mogliano Veneto, Italy) with four channels. The recorded signals will amplify sampled at 1024 Hz, and the acquired data will analyze with System Plus Evaluation software (Micromed, Via Giotto, Mogliano Veneto, Italy). The acquisitions will perform twice with the rest position of the mandible (RPM) for 10 seconds, in maximal intercuspal position (MIP) for five seconds and maximal teeth clenching (MTC) with 10-mm thick cotton rolls between the posterior teeth for five seconds, bilaterally, and the values obtained will be averaged.

  Assessment will be done before the injection (T0) and then at 2 weeks (T1), 3 months (T2), and 6 months after the injection (T3)

• Change in the perception of pain

  A visual analog scale (VAS) will be used for this assessment. A line of 100 mm in length will be used, and the patient will ask to put a mark on the line that reflects her/his perceived pain; the scores of the scale will be determined by measuring the distance in mm from the beginning to the point indicated by the patient (point (0): no pain and point (100): the highest levels of pain).

  Assessment will be done before the injection (T0) and then at 2 weeks (T1), 3 months (T2), and 6 months after the injection (T3)

Secondary Outcomes (2)

• Time to first observation of positive effects

  2 week

• Loss of effectiveness and side effects

  4 month

Study Arms (2)

Injection group

EXPERIMENTAL

In this group, patients will be injected with 10 MU of botulinum toxin type A in the masseter muscle.

Drug: BOTOX® Injection

Placebo group

PLACEBO COMPARATOR

In this group, patients will prick twice in the masseter muscle.

Other: Prick skin

Interventions

BOTOX® Injection DRUG

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

Injection group

Prick skin OTHER

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Moderate to severe pain in the masseter muscles during clinical examination.
• Age range between 18 and 40 years.
• Tooth-grinding sounds corroborated by family members or caregivers.
• Attrition in occlusal surface of posterior teeth.

You may not qualify if:

• Loss two posterior teeth or more (except for third molars).
• Fixed or movable prosthodontics for more than four dental units.
• Advanced malocclusion (Class II occlusion Model II - deep bite - open bite).
• Temporomandibular disorders.
• Pain in the orofacial region.
• Insomnia.
• Known botulinum toxin allergy.
• Pregnancy.
• Neuromuscular disease.
• Bleeding disorders.
• Antibiotic therapy, pulmonary disease that produced coughing during sleep.
• Infectious skin lesion at the site of the injection.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

University of Damascus

Damascus, Syria

Location

Related Publications (6)

• Manfredini D, Ahlberg J, Winocur E, Lobbezoo F. Management of sleep bruxism in adults: a qualitative systematic literature review. J Oral Rehabil. 2015 Nov;42(11):862-74. doi: 10.1111/joor.12322. Epub 2015 Jun 11.

  PMID: 26095208 BACKGROUND

• Carra MC, Huynh N, Lavigne G. Sleep bruxism: a comprehensive overview for the dental clinician interested in sleep medicine. Dent Clin North Am. 2012 Apr;56(2):387-413. doi: 10.1016/j.cden.2012.01.003.

  PMID: 22480810 BACKGROUND

• Lavigne GJ, Khoury S, Abe S, Yamaguchi T, Raphael K. Bruxism physiology and pathology: an overview for clinicians. J Oral Rehabil. 2008 Jul;35(7):476-94. doi: 10.1111/j.1365-2842.2008.01881.x.

  PMID: 18557915 BACKGROUND

• Lobbezoo F, Ahlberg J, Glaros AG, Kato T, Koyano K, Lavigne GJ, de Leeuw R, Manfredini D, Svensson P, Winocur E. Bruxism defined and graded: an international consensus. J Oral Rehabil. 2013 Jan;40(1):2-4. doi: 10.1111/joor.12011. Epub 2012 Nov 4.

  PMID: 23121262 BACKGROUND

• Sellin LC, Thesleff S. Pre- and post-synaptic actions of botulinum toxin at the rat neuromuscular junction. J Physiol. 1981 Aug;317:487-95. doi: 10.1113/jphysiol.1981.sp013838.

  PMID: 6273549 BACKGROUND

• Tan EK, Jankovic J. Treating severe bruxism with botulinum toxin. J Am Dent Assoc. 2000 Feb;131(2):211-6. doi: 10.14219/jada.archive.2000.0149.

  PMID: 10680389 BACKGROUND

MeSH Terms

Conditions

Sleep Bruxism

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Zaed Ghassan Shehri, DDS

  Department of Maxillofacial and oral surgery, Damascus University, Syria.

  PRINCIPAL INVESTIGATOR

• Issam Alkhouri, DDS,MSc,PhD

  Department of Maxillofacial and oral surgery, Damascus University, Syria.

  STUDY DIRECTOR

• Ibrahim Haddad, MSc,PhD

  Department of Basic Sciences, Damascus University, Syria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: November 17, 2022
• Study Start: March 15, 2021
• Primary Completion: September 15, 2021
• Study Completion: February 10, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)