Botulinum Toxin Type A Versus Oral Ibuprofen for Bruxism

NCT07732751 | Completed Phase 4

• 1 other identifier: KSTU-2026-014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluated the effectiveness of Botulinum Toxin Type A compared with oral ibuprofen in reducing pain and improving oral health-related quality of life in patients with sleep bruxism and jaw muscle pain. Forty participants diagnosed with sleep bruxism were randomly assigned to receive either Botulinum Toxin Type A injections into the masseter and temporalis muscles or oral ibuprofen therapy. Participants were followed for 20 weeks. The primary outcome was pain intensity measured using the Visual Analogue Scale (VAS). Secondary outcomes included oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14), muscle tenderness, and mandibular function.

Conditions

Bruxism; Myofascial Pain

Keywords

Botulinum Toxin Type A; Botulinum Neurotoxin Type A; Bruxism; Jaw Muscle Pain; Myofascial Pain; Oral Ibuprofen; Nonsteroidal Anti-inflammatory Drugs; Visual Analogue Scale; OHIP-14; Oral Health-Related Quality of Life; Randomized Controlled Trial; Masseter Muscle; Temporalis Muscle

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity Measured by the Visual Analogue Scale (VAS)

  Pain intensity will be assessed using the 10-point Visual Analogue Scale (VAS). Participants will mark their pain level on a horizontal line ranging from 0 (no pain) to 10 (worst pain imaginable). Pain severity may be interpreted as mild (1-3), moderate (4-6), or severe (7-9). The outcome measure will be the mean change in VAS score from baseline to each follow-up assessment. Lower scores indicate reduced pain intensity and improved treatment outcome.

  Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).

Secondary Outcomes (3)

• Change in Oral Health-Related Quality of Life (OHIP-14)

  Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).

• Change in Jaw Muscle Tenderness Assessed by Standardized Clinical Palpation

  Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).

• Change in Mandibular Functional Performance Assessed by Clinical Examination

  Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).

Study Arms (2)

Botulinum Toxin Type A

EXPERIMENTAL

Participants in this arm received Botulinum Toxin Type A (Otesaly® Botulinum Toxin Type A) was administered under aseptic conditions. A total dose of 100 units was used for each patient. Thirty units were injected into each masseter muscle and distributed across three standardized injection points (10 units per point) located within the prominent belly of the muscle. Twenty units were injected into each temporalis muscle and distributed across two injection points (10 units per point) within the anterior portion of the muscle. The injection sites were identified through clinical palpation while the patient performed maximal clenching to ensure accurate localization of muscle activity. All injections were performed using a standardized technique to ensure consistency among participants and minimize treatment variability.

Drug: Botulinum Toxin Type A 100U

Oral Ibuprofen

ACTIVE COMPARATOR

Participants in this arm received oral ibuprofen with 600 mg administered three times daily for one week.

Drug: Ibuprofen

Interventions

Botulinum Toxin Type A 100U DRUG

Botulinum Toxin Type A was administered by intramuscular injection into the bilateral masseter and temporalis muscles according to the study protocol. The intervention was performed once at baseline, and participants were followed for 20 weeks to evaluate pain intensity, oral health-related quality of life, muscle tenderness, and mandibular function.

Also known as: Otesaly

Botulinum Toxin Type A

Ibuprofen DRUG

Ibuprofen was administered orally at a dose of 600 mg three times daily for one week according to the study protocol. Participants were followed for 20 weeks to evaluate pain intensity, oral health-related quality of life, muscle tenderness, and mandibular function.

Also known as: Ibuprofen (600mg)

Oral Ibuprofen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Clinical diagnosis of sleep bruxism.
• Presence of jaw muscle pain.
• Ability to provide written informed consent.

You may not qualify if:

• Pregnancy or breastfeeding.
• Previous botulinum toxin treatment within 6 months.
• Neuromuscular disorders.
• Allergy to botulinum toxin or ibuprofen.
• Use of medications affecting neuromuscular function.

Sponsors & Collaborators

• NEW Cyprus Health and Social Sciences University: lead

Study Sites (1)

New Cyprus Health and Social Sciences University

Güzelyurt (Morphou), Northern Cyprus, 99750, Cyprus

Location

MeSH Terms

Conditions

Bruxism

Interventions

Botulinum Toxins, Type A; Ibuprofen

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

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; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the interventions (Botulinum Toxin Type A injections versus oral ibuprofen therapy), blinding of participants and the treating investigator was not feasible. Outcome assessment was based on standardized patient-reported outcome measures (VAS and OHIP-14), and statistical analyses were performed using coded data to minimize analytical bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomly assigned in a 1:1 ratio to one of two parallel treatment groups. The intervention group received Botulinum Toxin Type A injections into the bilateral masseter and temporalis muscles, while the control group received oral ibuprofen. Participants remained in their assigned treatment group throughout the 20-week follow-up period, and no crossover between treatment groups occurred.

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 29, 2026
• Study Start: February 6, 2026
• Primary Completion: June 26, 2026
• Study Completion: June 26, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)