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Botulinum Toxin Type A Versus Oral Ibuprofen for Bruxism

NCT07732751 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-29

No results posted yet for this study

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

Interventions

DRUG

Botulinum Toxin Type A 100U

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.

DRUG

Ibuprofen

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.

Sponsors & Collaborators

  • NEW Cyprus Health and Social Sciences University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-06
Primary Completion
2026-06-26
Completion
2026-06-26

Countries

  • Cyprus

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07732751 on ClinicalTrials.gov