Management of Bruxism in Patients With Implant Overdenture

NCT07361900 | Completed Phase 1

• 1 other identifier: FODMRC-2024-00100
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

implant overdenture; Botox; Bruxism; Splint

Outcome Measures

Primary Outcomes (1)

• Retention

  For all groups, retention of the implant-supported overdenture was measured using a digital force gauge device

  1month, 3 months, 6 months, 12 months

Secondary Outcomes (1)

• II. Electromyography

  1 months, 3 months, 6 months, 12 months

Study Arms (3)

Botox injection

ACTIVE COMPARATOR

Botox Administration 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

Drug: Botulinium toxin type A injection

Maxillary Occlusal Stabilization Splint

ACTIVE COMPARATOR

A maxillary full-arch hard clear acrylic muscle stabilization splint was fabricated for each participant. Each splint underwent intraoral evaluation to ensure optimal fit, retention, and stability on the maxillary dentition.

Device: Maxillary Occlusal Stabilization Splint

Removal of overdenture

NO INTERVENTION

Overdentures were removed at night

Interventions

Botulinium toxin type A injection DRUG

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).

Also known as: Botox

Botox injection

Maxillary Occlusal Stabilization Splint DEVICE

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

Maxillary Occlusal Stabilization Splint

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a confirmed diagnosis of definite sleep bruxism (SB)
• retention of natural dentition in the maxillary dental arch, without missing a single tooth of 6 anterior teeth, with no more than one or two missing premolar or molar teeth per quadrant
• existing implant-retained single overdentures (OD) that had been functionally loaded for at least one year prior to study initiation

You may not qualify if:

• had undergone any previous therapeutic interventions for bruxism
• exhibited medical conditions with known impacts on temporomandibular joint (TMJ) function, including (but not restricted to) post-radiation effects, osteoarthritis, or trauma-related pathologies.
• Any contraindication for BTX-A injection such as, allergy, pregnancy, and lactation.

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

Delta University for Science and Technology

Gamasa, Egypt

Location

MeSH Terms

Conditions

Bruxism

Interventions

Botulinum Toxins, Type A

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

Study Officials

• Wafaa I Ibrahim, Assoc. Prof.

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 23, 2026
• Study Start: March 24, 2024
• Primary Completion: July 30, 2025
• Study Completion: August 20, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)