NCT07096401

Brief Summary

This prospective clinical trial aims to evaluate the efficacy of clear aligner therapy compared to two different treatment modalities - anterior bite turbos and reverse curve of Spee (RCOS) archwires - for the correction of dental deep bite cases. Deep bite malocclusion is characterized by excessive vertical overlap of the anterior teeth and often requires intrusion of anterior teeth and leveling of the curve of Spee. In this study, 27 patients aged 16-30 years with an overbite ≥5 mm and no significant skeletal discrepancies will be randomly assigned into three equal groups: Group 1 (RCOS archwire), Group 2 (anterior bite turbos), and Group 3 (clear aligners). Cone-beam computed tomography (CBCT) will be used to assess changes in overbite and alveolar bone height and thickness before and after treatment. The primary outcome is the efficacy of overbite correction, and the secondary outcome is the assessment of alveolar bone remodeling. The study will be conducted at the Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University (Assiut Branch), and has been approved by the institutional ethical committee.

Trial Health

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Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
17mo left

Started Oct 2025

Typical duration for not_applicable

Status
not yet recruiting

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 Progress30%
Oct 2025Oct 2027

First Submitted

Initial submission to the registry

July 16, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

July 16, 2025

Last Update Submit

August 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in overbite

    Mean change in overbite (in mm) measured using CBCT imaging

    Baseline and 6 months after treatment start

Study Arms (3)

RCOS Archwire Group

EXPERIMENTAL

Patients treated with reverse curve of Spee archwire (0.016 × 0.022 NiTi) to correct deep bite via posterior extrusion and anterior intrusion.

Device: Reverse Curve of Spee Archwire

Anterior Bite Turbos Group

EXPERIMENTAL

Patients treated with anterior bite turbos bonded to the palatal surface of upper central incisors to correct deep bite.

Device: Anterior Bite Turbos

Clear Aligners Group

EXPERIMENTAL
Device: Clear Aligners

Interventions

Orthodontic treatment using a 0.016 × 0.022 NiTi reverse curve of Spee archwire to correct deep bite through posterior extrusion and anterior intrusion.

RCOS Archwire Group

Orthodontic treatment using anterior bite turbos bonded to the palatal surfaces of the upper central incisors to promote posterior extrusion and correct deep bite.

Anterior Bite Turbos Group

Orthodontic treatment using clear aligner therapy designed for anterior intrusion and leveling of the curve of Spee to correct deep bite.

Clear Aligners Group

Eligibility Criteria

Age16 Years - 30 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- Age between 16 and 30 years.
  • Overbite of 5 mm or more.
  • Full permanent dentition (excluding third molars).
  • Good oral hygiene.
  • No previous orthodontic or orthognathic treatment.

You may not qualify if:

  • Severe skeletal Class II or III requiring surgery.
  • Overjet greater than 6 mm.
  • Craniofacial anomalies.
  • Systemic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The efficacy of aligner therapy versus two different methods for correction of deep bite cases. cone-beam computed tomography study

Study Record Dates

First Submitted

July 16, 2025

First Posted

July 31, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

August 3, 2025

Record last verified: 2025-07