NCT07851948

Brief Summary

This study evaluated how anterior bite turbos used during orthodontic treatment of deep bite affect chewing muscle activity and dental and skeletal measurements. Participants were followed in two nonrandomized groups: one received anterior bite turbos as part of orthodontic treatment, and the other received orthodontic treatment without bite turbos. Surface electromyography (EMG) was used to measure muscle activity over time. Cephalometric measurements were also evaluated to assess treatment-related changes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

September 25, 2026

Last Update Submit

September 30, 2026

Conditions

Keywords

Anterior bite turboSurface electromyographyDeep overbiteMasticatory musclesOrthodontic treatment

Outcome Measures

Primary Outcomes (6)

  • Change in Mean Bilateral Masseter Muscle Activity at Rest

    Surface electromyographic activity of the right and left masseter muscles was recorded at rest. The mean of the two sides, measured in microvolts (µV), was evaluated at baseline, 1 month, and 6 months. Changes over time were compared between the anterior bite turbo and no bite turbo groups.

    Baseline (before bite turbo placement), 1 month, and 6 months

  • Change in Mean Bilateral Anterior Digastric Muscle Activity During Maximum Voluntary Clenching

    Surface EMG amplitude of the right and left anterior digastric muscles during maximum voluntary clenching was averaged for each participant and measured in microvolts (µV). Change over time was compared between groups.

    Baseline (T0), 1 month (T2), and 6 months (T3).

  • Change in Mean Bilateral Anterior Digastric Muscle Activity at Rest

    Surface EMG amplitude of the right and left anterior digastric muscles at rest was averaged for each participant and measured in microvolts (µV). Change over time was compared between groups.

    Baseline (T0), 1 month (T2), and 6 months (T3).

  • Change in Mean Bilateral Anterior Temporalis Muscle Activity During Maximum Voluntary Clenching

    Surface EMG amplitude of the right and left anterior temporalis muscles during maximum voluntary clenching was averaged for each participant and measured in microvolts (µV). Change over time was compared between groups.

    Baseline (T0), 1 month (T2), and 6 months (T3).

  • Change in Mean Bilateral Anterior Temporalis Muscle Activity at Rest

    Surface EMG amplitude of the right and left anterior temporalis muscles at rest was averaged for each participant and measured in microvolts (µV). Change over time was compared between groups.

    Baseline (T0), 1 month (T2), and 6 months (T3).

  • Change in Mean Bilateral Masseter Muscle Activity During Maximum Voluntary Clenching

    Surface EMG amplitude of the right and left masseter muscles during maximum voluntary clenching was averaged for each participant and measured in microvolts (µV). Change over time was compared between groups.

    Baseline (T0), 1 month (T2), and 6 months (T3).

Secondary Outcomes (11)

  • Change in Overbite

    Baseline and 6 months.

  • Change in Overjet

    Baseline and 6 months.

  • Change in SN-GoGn Angle

    Baseline and 6 months.

  • Change in Overbite

    Baseline and 6 months.

  • Change in ANB Angle

    Baseline and 6 months.

  • +6 more secondary outcomes

Study Arms (2)

Anterior Bite Turbo Group

EXPERIMENTAL

Participants received anterior bite turbos as part of fixed orthodontic treatment for deep bite. Surface EMG and orthodontic measurements were obtained during follow-up.

Device: Anterior Bite TurboProcedure: Fixed Orthodontic Treatment

No Bite Turbo Group

ACTIVE COMPARATOR

Participants received fixed orthodontic treatment without anterior bite turbos during the study period. Surface EMG and orthodontic measurements were obtained during follow-up.

Procedure: Fixed Orthodontic Treatment

Interventions

Composite resin bite turbos were bonded to the palatal surfaces of the maxillary central incisors during fixed orthodontic treatment. The bite turbos were used to disclude the posterior teeth during deep bite treatment.

Anterior Bite Turbo Group

Participants received fixed orthodontic treatment for deep bite.

Anterior Bite Turbo GroupNo Bite Turbo Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Permanent dentition.
  • Angle Class I or Class II malocclusion.
  • Mild to moderate dental crowding (≤6 mm).
  • Non-extraction fixed orthodontic treatment planned.
  • No missing teeth, excluding third molars.
  • For the anterior bite turbo group: increased overbite (\>4 mm).
  • For the control group: normal anterior overbite (2-3 mm).

You may not qualify if:

  • Bruxism or other oral parafunctional habits.
  • Temporomandibular joint disorder.
  • Craniofacial asymmetry, craniofacial syndrome, or cleft lip and/or palate.
  • Dental anomalies, including missing teeth other than third molars or abnormalities of tooth shape.
  • Previous orthodontic or myofunctional treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University, Faculty of Dentistry, Department of Orthodontics

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (2)

  • Al-Zoubi EM, Al-Nimri KS. A comparative study between the effect of reverse curve of Spee archwires and anterior bite turbos in the treatment of deep overbite cases. Angle Orthod. 2022 Jan 1;92(1):36-44. doi: 10.2319/020921-117.1.

    PMID: 34329389BACKGROUND
  • Wasinwasukul P, Nalamliang N, Pairatchawan N, Thongudomporn U. Effects of anterior bite planes fabricated from acrylic resin and thermoplastic material on masticatory muscle responses and maximum bite force in children with a deep bite: A 6-month randomised controlled trial. J Oral Rehabil. 2022 Oct;49(10):980-992. doi: 10.1111/joor.13351. Epub 2022 Jul 3.

    PMID: 35730261BACKGROUND

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class IIMalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Ayşe T Altuğ Demiralp, DDS, PhD, Professor

    Ankara University Faculty of Dentistry Department of Orthodontics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were followed in two parallel, nonrandomized groups. One group received anterior bite turbos during orthodontic treatment; the comparison group received orthodontic treatment without anterior bite turbos during the study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 1, 2026

Study Start

October 20, 2025

Primary Completion

August 28, 2026

Study Completion

August 28, 2026

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

There is currently no plan to share individual participant data with other researchers.

Locations