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Management of Bruxism in Patients With Implant Overdenture

NCT07361900 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-01-23

No results posted yet for this study

Summary

Objective To compare the effects of botulinum toxin type A (BTX-A) injections, occlusal stabilization splint therapy, and nocturnal overdenture removal on masticatory muscle activity and overdenture retention in patients with sleep bruxism wearing implant-retained mandibular overdentures.

Methods This randomized, single-blind, parallel-group clinical trial allocated patients with definite sleep bruxism to one of three groups (1:1:1): BTX-A injections with nocturnal overdenture wear, occlusal stabilization splint therapy with nocturnal overdenture wear, or nocturnal overdenture removal (control). Electromyographic (EMG) activity of the masseter and temporalis muscles was assessed at baseline and at 3, 6, 9, and 12 months. Overdenture retention was measured at 1, 3, 6, and 12 months using a digital force gauge. Intergroup comparisons were performed using one-way ANOVA with Tukey's post hoc test, and intragroup comparisons using repeated-measures ANOVA (α = 0.05).

Conditions

  • Bruxism

Interventions

DRUG

Botulinium toxin type A injection

Botulinum toxin type A (BTX-A; Botox, Allergan, Inc., Irvine, CA, USA) was administered through intramuscular injection into the masseter and temporalis muscles during a single treatment session. The masseter muscle received 30 units of BTX-A, while the temporalis muscle received 25 units. All injections were guided by electromyography (EMG).

DEVICE

Maxillary Occlusal Stabilization Splint

A maxillary full-arch hard clear acrylic muscle stabilization splint was fabricated for each participant

Sponsors & Collaborators

  • Delta University for Science and Technology

    lead OTHER

Principal Investigators

  • Wafaa I Ibrahim, Assoc. Prof. · Associate Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-24
Primary Completion
2025-07-30
Completion
2025-08-20

Countries

  • Egypt

Study Locations

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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 NCT07361900 on ClinicalTrials.gov