An interventional study of Fixed Orthodontic Appliance With Composite Anterior Bite Raiser in Deep Bite, Skeletal Class I Malocclusion and Anterior Bite, sponsored by Can Tho University of Medicine and Pharmacy. Completed at 1 site in Vietnam. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Can Tho University of Medicine and Pharmacy · Not applicable, Interventional, and Treatment
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.
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.
Can Tho University of Medicine and Pharmacy is the lead sponsor of 35 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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.
Procedure: Fixed Orthodontic Appliance With Composite Anterior Bite Raiser
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.
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.
Time frame: Baseline and through study completion, an average of 12months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and at treatment completion (approximately 12 months).
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Ran from May 2025 to primary completion in Sep 2026, 16 months.
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Overbite
Can Tho University of Medicine and Pharmacy