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BruxismPhase 1NCT07361900

Management of Bruxism in Patients With Implant Overdenture

A Phase 1 study testing Botulinium toxin type A injection and Maxillary Occlusal Stabilization Splint in people with Bruxism, run by Delta University for Science and Technology at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Bruxism
What is being tested?
Botulinium toxin type A injection and Maxillary Occlusal Stabilization Splint
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteEgypt
Study dates
24 Mar 2024to 20 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Delta University for Science and Technology

    Gamasa

Other trials in Egypt

About this study

Official title: Comparative Analysis of Botox, Occlusal Splints and Traditional Management of Bruxism in Patients With Implant Overdenture: A Randomized Controlled Trial.

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).

Read the detailed description

Diagnosis of sleep bruxism Electromyography (EMG) is a valuable tool for diagnosing sleep bruxism (SB), as it records electrical activity in the masticatory muscles (e.g., masseter and temporalis) during sleep, providing objective data on the frequency, duration, and intensity of muscle contractions. Unlike subjective patient reports or clinical examinations, EMG can detect SB episodes even when patients are unaware of their bruxism, which occurs in up to 80% of cases. While polysomnography (PSG) remains the gold standard for SB diagnosis due to its comprehensive monitoring of brain activity, muscle movements, and other physiological parameters, ambulatory EMG offers a more practical and accessible alternative for clinical settings. Despite this, EMG is widely used in research and clinical practice, particularly when combined with patient history and clinical examination, to achieve a reliable SB diagnosis conducted the assessments to minimize measurement bias.

Prosthetic Protocol

All participants received newly fabricated ODs to replace existing prostheses with compromised artificial dentition. The prosthetic rehabilitation included:

  1. Installation of medium-retention nylon caps within metal housings to ensure consistent retention parameters
  2. Restoration of opposing partially edentulous arches with fixed partial dentures
  3. A one-month adaptation period incorporating necessary occlusal adjustments and prosthetic modifications Intervention Protocols Throughout the study duration, distinct wearing protocols were implemented for each experimental group: Groups I and II maintained continuous OD wear during sleep. Group I received BTX-A injection; Group II received additional intervention through conventional maxillary occlusal stabilization splints and Group III (Control Group) participants were instructed to remove their overdentures (ODs) during nocturnal sleep periods.

Group I protocol:

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 (EMG).

Reconstitution of BTX-A BTX-A reconstitution and syringe preparation were performed on a plastic-lined paper towel. The lyophilized BTX-A was reconstituted with 0.9% sodium chloride (normal saline) to achieve a final concentration of 10 units/0.1 mL. The precise volume of diluent, as outlined in the product insert, was drawn into a reconstitution syringe. The needle was then carefully inserted into the vial, which was positioned at a 45° angle. Saline was gently injected towards the vial walls to prevent BTX-A denaturation from bubbling or vigorous agitation. The presence of a vacuum within the vial confirmed its sterility. The vacuum was released by detaching the syringe from the needle, allowing atmospheric air to enter the vial. The reconstituted solution was visually inspected for clarity and the absence of particulate matter, appearing as a clear, colorless to slightly yellow solution. The solution was then drawn into the injection syringe by positioning the needle at the vial's bottom corner for complete extraction, after which the syringe was disconnected from the vial.

BTX-A Injection Protocol The reconstituted BTX-A solution was utilized immediately after preparation. Patients were seated in a comfortable upright position without head support, ensuring the Frankfort horizontal plane was parallel to the floor. No topical, local, or general anesthesia was administered prior to or during the injection procedure. The injection site on the patient's skin was disinfected using povidone-iodine U.S.P. 10% W/V.

A hollow, Teflon-coated, monopolar, disposable 27-gauge, 37-mm hypodermic needle electrode was employed for both muscle localization and drug delivery. This electrode was connected via a specialized cable to an audio-amplified electromyographic apparatus. A reference electrode was positioned centrally on the patient's forehead, with conductivity enhanced by applying conductive paste after thorough skin cleaning with alcohol. A ground electrode was placed on the forearm.

For the masseter muscle, anatomical landmarks were identified by palpation during clenching. Accurate needle tip placement was confirmed by a discernible "pop" upon fascial plane penetration, followed by positive EMG activity during clenching and the absence of EMG activity at rest. The EMG apparatus provided both auditory and visual feedback of muscle activity. For the temporalis muscle, the hypodermic needle electrode was inserted into the muscle fibers posterior to the frontal process of the zygomatic bone, approximately 1.5 to 2 cm superior to the zygomatic arch.

Upon proper needle positioning, aspiration was performed to confirm that the needle tip was not within a blood vessel. The reconstituted BTX-A was then injected slowly and gently after instructing the patient to relax the muscle. Post-injection, patients were advised to avoid strenuous physical activity for 24 hours, refrain from lying down for four to five hours following treatment, and to avoid massaging the treated area. Patients were also instructed to report BTX-A injections as part of their medical history. The procedure was repeated every 6 months for one year. All procedures were carried out by a certified practitioner (SM) throughout the study.

Group II Specific Protocol:

Maxillary Occlusal Stabilization Splint A maxillary full-arch hard clear acrylic muscle stabilization splint was fabricated for each participant in Group II. Each splint underwent intraoral evaluation to ensure optimal fit, retention, and stability on the maxillary dentition. Occlusal adjustments and refinements were meticulously performed directly in the patient's mouth. Following occlusal refinement, the splint was meticulously smoothed and polished to prevent irritation to adjacent soft tissues. Comprehensive instructions regarding splint usage and maintenance were provided to each patient. Compliance with nightly wear was required for the entire 12-month study period.

Electromyographic Analysis Protocol Patients' muscle activity was evaluated at baseline (one month from new overdenture insertion), and at 3, 6,9, and 12 months using electromyographic quantitative interference pattern analysis (QIPA) QIPA was conducted through surface EMG recordings of masseter and temporalis muscle activity during maximal voluntary clenching. The acquisition parameters were standardized as follows: Sweep speed: 100 ms/division, Sensitivity: 1 mV/division, and Bandpass filter: 20 Hz to 10 kHz.

The interference pattern analysis evaluated three key parameters:

  1. Mean amplitude (mV): Calculated as the average potential difference between successive turns
  2. Turn count: Quantified as the number of potential reversals exceeding 100 μV/ms, irrespective of baseline
  3. Activity percentage: Representing the density of electromyographic activity within the interference pattern For each muscle group (masseter and temporalis), twenty consecutive recordings were obtained and analyzed to ensure data reliability.

The surface electrodes were positioned on the superficial masseter and anterior temporalis muscle and these positions were transferred to the clear template which was pierced at these points. Alcohol swabs (70% isopropyl alcohol) were used to clean their skin at the marked positions. The ground electrode was positioned on the forehead. Conductive EEG paste was filled on the inner sides of the electrodes. Adhesive tape was used to fix the reference electrodes on the corresponding positions. During silent reading by the patients, the right and left temporalis and masseter muscle's surface EMG activity was recorded.

All EMG'S tests were performed for all patients by the same assessor and under the same environmental conditions. The technique used and the guidelines were previously explained to the patient.

Conditions
Bruxism
Being tested
Botulinium toxin type A injection, Maxillary Occlusal Stabilization Splint
Keywords
implant overdenture, Botox, Bruxism, Splint
Medical subject headings
Bruxism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinium toxin type A injectionDrug

    Also called Botox

    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).

  • Maxillary Occlusal Stabilization SplintDevice

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

Study groups in NCT07361900
Study groupRoleWhat they receive
Botox injectionActive comparatorBotox 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
Receives: Drug: Botulinium toxin type A injection
Maxillary Occlusal Stabilization SplintActive comparatorA 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.
Receives: Device: Maxillary Occlusal Stabilization Splint
Removal of overdentureNo interventionOverdentures were removed at night

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention

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

    Measured: 1month, 3 months, 6 months, 12 months

Secondary outcomes (1)
  1. II. Electromyography

    Patients' muscle activity was evaluated at baseline using electromyographic quantitative interference pattern analysis (QIPA). QIPA was conducted through surface EMG recordings of masseter and temporalis muscle activity during maximal voluntary clenching.

    Measured: 1 months, 3 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start24 Mar 2024
  3. Primary completion30 Jul 2025
  4. Study completion20 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07361900
Sponsor's protocol ID
FODMRC-2024-00100
Status last verified
Jan 2026
First submitted
7 Jan 2026
Last updated
23 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Botulinium toxin type A injection and Maxillary Occlusal Stabilization Splint in people with Bruxism, run by Delta University for Science and Technology at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention (time frame: 1month, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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