Deep BiteNCT07907263

Effects of Anterior Bite Raisers Combined With Fixed Orthodontic Appliances in Deep Bite Treatment

A study testing Fixed Orthodontic Appliance With Composite Anterior Bite Raiser in people with Deep Bite and Skeletal Class I Malocclusion, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.

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

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Deep Bite, Skeletal Class I Malocclusion, Anterior Bite
What is being tested?: Fixed Orthodontic Appliance With Composite Anterior Bite Raiser
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteVietnam
Study dates: 3 May 2025to 15 Sep 2026
Phase: Interventional
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Permanent dentition.
Skeletal Class I relationship with ANB angle >0° and <4°.
Angle Class I or Class II malocclusion.
Deep bite with overbite ≥3 mm or greater than 40% coverage of the mandibular incisor crown.
Voluntary participation in the study.

Who cannot join

Maxillary central incisors with prosthetic restorations.
Indication for combined orthodontic and orthognathic surgical treatment.
Congenital craniofacial anomalies.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

Ho Chi Minh City Hospital of Odonto-Stomatology
Ho Chi Minh City

Other trials in Vietnam

About this study

This clinical study evaluated the treatment outcomes of fixed orthodontic appliances combined with anterior bite raisers in patients with skeletal Class I malocclusion and deep bite. Participants received fixed orthodontic treatment with composite anterior bite raisers bonded to the palatal surfaces of the maxillary central incisors. Clinical and cephalometric measurements were obtained before treatment and after achievement of the predefined treatment endpoints. Changes in overbite, overjet, curve of Spee, dental relationships, skeletal measurements, dental measurements, and soft-tissue measurements were evaluated.

Read the detailed description

Patients with skeletal Class I malocclusion and deep bite who met the eligibility criteria were recruited at the Ho Chi Minh City Odonto-Stomatology Hospital.

All participants received self-ligating fixed orthodontic appliances with a 0.022-inch MBT prescription. Composite anterior bite raisers measuring approximately 1.5 × 3 × 5 mm were bonded to the palatal surfaces of the two maxillary central incisors at the time of bracket bonding.

Participants were reviewed every four weeks. The archwire sequence was 0.014-inch NiTi, 0.018-inch NiTi, 0.018-inch stainless steel, 0.017 × 0.025-inch NiTi, and 0.017 × 0.025-inch stainless steel. Vertical elastics were used when indicated.

Treatment outcomes were evaluated when overbite was less than 3 mm or no more than one-third of the lower incisor crown height and the first permanent molars achieved a Class I relationship. Post-treatment records included digital dental scans, photographs, panoramic radiographs, and lateral cephalometric radiographs.

Conditions: Deep Bite, Skeletal Class I Malocclusion, Anterior Bite
Being tested: Fixed Orthodontic Appliance With Composite Anterior Bite Raiser
Keywords: anterior bite, Deep bite, Fixed Orthodontic Appliance
Medical subject headings: Overbite

What participants receive

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

Fixed Orthodontic Appliance With Composite Anterior Bite RaiserProcedure or surgery
Participants were treated with self-ligating fixed orthodontic appliances with a 0.022-inch MBT prescription. Composite anterior bite raisers measuring approximately 1.5 × 3 × 5 mm were bonded to the palatal surfaces of the two maxillary central incisors at the time of bracket bonding. Participants were reviewed every 4 weeks, and the archwire sequence was 0.014-inch NiTi, 0.018-inch NiTi, 0.018-inch stainless steel, 0.017 × 0.025-inch NiTi, and 0.017 × 0.025-inch stainless steel. Vertical elastics were used when indicated.

Study groups in NCT07907263
Study group	Role	What they receive
Fixed Orthodontic Appliance Combined With Anterior Bite Raiser	Experimental	Participants received fixed orthodontic treatment using self-ligating 0.022-inch MBT brackets combined with composite anterior bite raisers bonded to the palatal surfaces of the maxillary central incisors. Participants were followed every 4 weeks until the predefined deep-bite correction criteria were achieved. Receives: Procedure: Fixed Orthodontic Appliance With Composite Anterior Bite Raiser

What is being measured

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

Changes in Linear Occlusal Measurements
Changes in linear occlusal measurements used to assess overbite, overjet, and the Curve of Spee. All linear measurements are reported in millimeters.
Measured: Baseline and through study completion, an average of 12months

Secondary outcomes (20)

Change From Baseline in SNA Angle (Degrees)
The SNA angle will be measured using standardized lateral cephalometric radiographs analyzed with WebCeph software. Changes will be calculated as post-treatment minus baseline values and reported in degrees.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in SNB Angle (Degrees)
The SNB angle will be measured using standardized lateral cephalometric radiographs analyzed with WebCeph software. Changes will be calculated as post-treatment minus baseline values and reported in degrees.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in ANB Angle (Degrees)
The ANB angle will be measured using standardized lateral cephalometric radiographs analyzed with WebCeph software. Changes will be calculated as post-treatment minus baseline values and reported in degrees.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in SN-GoGn Angle (Degrees)
The SN-GoGn angle will be measured using lateral cephalometric radiographs analyzed with WebCeph software. The change will be calculated as the post-treatment value minus the baseline value and reported in degrees.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in SN-PP Angle (Degrees)
The angle between the Sella-Nasion plane and palatal plane (SN-PP) will be measured using lateral cephalometric radiographs analyzed with WebCeph software. The change will be reported in degrees.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in PP-MP Angle (Degrees)
The angle between the palatal plane and mandibular plane (PP-MP) will be measured using lateral cephalometric radiographs analyzed with WebCeph software. The change will be reported in degrees.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in SN-OcP Angle (Degrees)
The angle between the Sella-Nasion plane and occlusal plane (SN-OcP) will be measured using lateral cephalometric radiographs analyzed with WebCeph software. The change will be reported in degrees.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Gonial Angle (Degrees)
The gonial angle will be measured using lateral cephalometric radiographs analyzed with WebCeph software. The change will be reported in degrees.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Frankfort-Mandibular Plane Angle (Degrees)
The angle between the Frankfort horizontal plane and mandibular plane (FMA) will be measured using lateral cephalometric radiographs analyzed with WebCeph software. The change will be reported in degrees.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in U1-SN Angle (Degrees)
The U1-SN angle will be measured using standardized lateral cephalometric radiographs analyzed with WebCeph software. The change will be calculated as the post-treatment value minus the baseline value and reported in degrees.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in U1-NA Angle (Degrees)
The U1-NA angle will be measured using standardized lateral cephalometric radiographs analyzed with WebCeph software. The change will be calculated as the post-treatment value minus the baseline value and reported in degrees.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in L1-NB Angle (Degrees)
The L1-NB angle will be measured using standardized lateral cephalometric radiographs analyzed with WebCeph software. The change will be calculated as the post-treatment value minus the baseline value and reported in degrees.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Interincisal Angle (U1-L1, Degrees)
The interincisal angle (U1-L1) will be measured using standardized lateral cephalometric radiographs analyzed with WebCeph software. The change will be calculated as the post-treatment value minus the baseline value and reported in degrees.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Upper Incisor Vertical Position (U1-PP, Millimeters)
The perpendicular distance from the upper central incisor tip to the palatal plane (U1-PP) will be measured using WebCeph software. The change will be calculated as the post-treatment value minus the baseline value and reported in millimeters.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Upper Incisor Vertical Position (U1-FH, Millimeters)
The perpendicular distance from the upper central incisor tip to the Frankfort horizontal plane (U1-FH) will be measured using WebCeph software. The change will be calculated as the post-treatment value minus the baseline value and reported in millimeters.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Lower Incisor Vertical Position (L1-MP, Millimeters)
The perpendicular distance from the lower central incisor tip to the mandibular plane (L1-MP) will be measured using WebCeph software. The change will be calculated as the post-treatment value minus the baseline value and reported in millimeters.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Upper First Molar Vertical Position (U6-PP, Millimeters)
The perpendicular distance from the upper first molar reference cusp to the palatal plane (U6-PP) will be measured using WebCeph software. The change will be calculated as the post-treatment value minus the baseline value and reported in millimeters.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Upper Lip Position Relative to E-Line (Millimeters)
The distance from the upper lip (Ls) to the esthetic E-line will be measured using standardized lateral cephalometric radiographs analyzed with WebCeph software. Changes will be calculated as post-treatment minus baseline values and reported in millimeters.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Lower Lip Position Relative to E-Line (Millimeters)
The distance from the lower lip (Li) to the esthetic E-line will be measured using standardized lateral cephalometric radiographs analyzed with WebCeph software. Changes will be calculated as post-treatment minus baseline values and reported in millimeters.
Measured: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Nasolabial Angle (Degrees)
The nasolabial angle will be measured using standardized lateral cephalometric radiographs analyzed with WebCeph software. Changes will be calculated as post-treatment minus baseline values and reported in degrees.
Measured: Baseline and at treatment completion (approximately 12 months).

Timeline

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

3 May 202515 Sep 2026

First posted30 Oct 2026
Study start3 May 2025
Primary completion15 Sep 2026
Study completion15 Sep 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Deep BiteStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07907263
Sponsor's protocol ID: 25.559.HV
Status last verified: May 2026
First submitted: 7 Oct 2026
Last updated: 30 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Deep Bite trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Anterior Bite Raisers Combined With Fixed Orthodontic Appliances in Deep Bite Treatment
ClinicalTrials.gov ID: NCT07907263
Acronym / sponsor ID: 25.559.HV
Conditions: Deep Bite, Skeletal Class I Malocclusion, Anterior Bite
Keywords: anterior bite, Deep bite, Fixed Orthodontic Appliance
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Can Tho University of Medicine and PharmacyUniversity, hospital or other
Study start: 3 May 2025 (actual)
Primary completion: 15 Sep 2026 (actual)
Study completion: 15 Sep 2026 (actual)
First posted: 30 Oct 2026 (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.

Detailed description

Patients with skeletal Class I malocclusion and deep bite who met the eligibility criteria were recruited at the Ho Chi Minh City Odonto-Stomatology Hospital.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fixed Orthodontic Appliance Combined With Anterior Bite Raiser	Experimental	Procedure: Fixed Orthodontic Appliance With Composite Anterior Bite RaiserParticipants received fixed orthodontic treatment using self-ligating 0.022-inch MBT brackets combined with composite anterior bite raisers bonded to the palatal surfaces of the maxillary central incisors. Participants were followed every 4 weeks until the predefined deep-bite correction criteria were achieved.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Permanent dentition.
Skeletal Class I relationship with ANB angle >0° and <4°.
Angle Class I or Class II malocclusion.
Deep bite with overbite ≥3 mm or greater than 40% coverage of the mandibular incisor crown.
Voluntary participation in the study.

Key exclusion criteria (3 listed)

Maxillary central incisors with prosthetic restorations.
Indication for combined orthodontic and orthognathic surgical treatment.
Congenital craniofacial anomalies.

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
Fixed Orthodontic Appliance With Composite Anterior Bite RaiserParticipants were treated with self-ligating fixed orthodontic appliances with a 0.022-inch MBT prescription. Composite anterior bite raisers measuring approximately 1.5 × 3 × 5 mm were bonded to the palatal surfaces of the two maxillary central incisors at the time of bracket bonding. Participants were reviewed every 4 weeks, and the archwire sequence was 0.014-inch NiTi, 0.018-inch NiTi, 0.018-inch stainless steel, 0.017 × 0.025-inch NiTi, and 0.017 × 0.025-inch stainless steel. Vertical elastics were used when indicated.	Procedure or surgery	Fixed Orthodontic Appliance Combined With Anterior Bite Raiser

Primary outcome

Changes in Linear Occlusal Measurements
Time frame: Baseline and through study completion, an average of 12months
Changes in linear occlusal measurements used to assess overbite, overjet, and the Curve of Spee. All linear measurements are reported in millimeters.

20 secondary outcomes

Change From Baseline in SNA Angle (Degrees)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in SNB Angle (Degrees)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in ANB Angle (Degrees)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in SN-GoGn Angle (Degrees)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in SN-PP Angle (Degrees)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in PP-MP Angle (Degrees)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in SN-OcP Angle (Degrees)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Gonial Angle (Degrees)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Frankfort-Mandibular Plane Angle (Degrees)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in U1-SN Angle (Degrees)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in U1-NA Angle (Degrees)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in L1-NB Angle (Degrees)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Interincisal Angle (U1-L1, Degrees)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Upper Incisor Vertical Position (U1-PP, Millimeters)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Upper Incisor Vertical Position (U1-FH, Millimeters)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Lower Incisor Vertical Position (L1-MP, Millimeters)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Upper First Molar Vertical Position (U6-PP, Millimeters)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Upper Lip Position Relative to E-Line (Millimeters)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Lower Lip Position Relative to E-Line (Millimeters)
Time frame: Baseline and at treatment completion (approximately 12 months).
Change From Baseline in Nasolabial Angle (Degrees)
Time frame: Baseline and at treatment completion (approximately 12 months).

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Deep Bite

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Not yet recruiting
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Recruiting
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Recruiting
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Not yet recruitingObservational study
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 30 Oct 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 Vietnam. 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.

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?

Changes in Linear Occlusal Measurements (time frame: Baseline and through study completion, an average of 12months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07907263.

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 30 Oct 2026.