Deep Bite MalocclusionDB-CBCTNCT07096401
Efficacy of Aligners vs ABT and RCOS for Deep Bite Correction: CBCT Study
A study testing Reverse Curve of Spee Archwire, Anterior Bite Turbos and Clear Aligners in people with Deep Bite Malocclusion, run by Al-Azhar University.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Bite Malocclusion
- What is being tested?
- Reverse Curve of Spee Archwire, Anterior Bite Turbos and Clear Aligners
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Severe skeletal Class II or III requiring surgery.
- Overjet greater than 6 mm.
- Craniofacial anomalies.
- Systemic diseases.
About this study
Official title: The Efficacy of Aligner Therapy Versus Anterior Bite Turbos and Reverse Curve of Spee Archwires for Correction of Deep Bite Cases: A Cone-beam Computed Tomography Study
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).
Read more
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.
- Conditions
- Deep Bite Malocclusion
- Being tested
- Reverse Curve of Spee Archwire, Anterior Bite Turbos, Clear Aligners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse Curve of Spee ArchwireDevice
Orthodontic treatment using a 0.016 × 0.022 NiTi reverse curve of Spee archwire to correct deep bite through posterior extrusion and anterior intrusion.
Anterior Bite TurbosDevice
Orthodontic treatment using anterior bite turbos bonded to the palatal surfaces of the upper central incisors to promote posterior extrusion and correct deep bite.
Clear AlignersDevice
Orthodontic treatment using clear aligner therapy designed for anterior intrusion and leveling of the curve of Spee to correct deep bite.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Anterior Bite Turbos |
| Clear Aligners Group | Experimental | Not described Receives: Device: Clear Aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overbite
Mean change in overbite (in mm) measured using CBCT imaging
Measured: Baseline and 6 months after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Bite MalocclusionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Alaa Eldien Elsayed Ahmed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096401
- Sponsor's protocol ID
- AU-Ortho-DB-2025
- Acronym
- DB-CBCT
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Aligner Therapy Versus Anterior Bite Turbos and Reverse Curve of Spee Archwires for Correction of Deep Bite Cases: A Cone-beam Computed Tomography Study
- ClinicalTrials.gov ID
- NCT07096401
- Acronym / sponsor ID
- DB-CBCT / AU-Ortho-DB-2025
- Conditions
- Deep Bite Malocclusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RCOS Archwire Group | Experimental | Device: Reverse Curve of Spee ArchwirePatients treated with reverse curve of Spee archwire (0.016 × 0.022 NiTi) to correct deep bite via posterior extrusion and anterior intrusion. |
| Anterior Bite Turbos Group | Experimental | Device: Anterior Bite TurbosPatients treated with anterior bite turbos bonded to the palatal surface of upper central incisors to correct deep bite. |
| Clear Aligners Group | Experimental | Device: Clear Aligners |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Severe skeletal Class II or III requiring surgery.
- Overjet greater than 6 mm.
- Craniofacial anomalies.
- Systemic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reverse Curve of Spee ArchwireOrthodontic treatment using a 0.016 × 0.022 NiTi reverse curve of Spee archwire to correct deep bite through posterior extrusion and anterior intrusion. | Device | RCOS Archwire Group |
| Anterior Bite TurbosOrthodontic treatment using anterior bite turbos bonded to the palatal surfaces of the upper central incisors to promote posterior extrusion and correct deep bite. | Device | Anterior Bite Turbos Group |
| Clear AlignersOrthodontic treatment using clear aligner therapy designed for anterior intrusion and leveling of the curve of Spee to correct deep bite. | Device | Clear Aligners Group |
Primary outcome
Change in overbite
Time frame: Baseline and 6 months after treatment start
Mean change in overbite (in mm) measured using CBCT imaging
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Reverse Curve of Spee Archwire, Anterior Bite Turbos and Clear Aligners in people with Deep Bite Malocclusion, run by Al-Azhar University.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in overbite (time frame: Baseline and 6 months after treatment start). 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 3 Aug 2025.