An interventional study of Power Bar Distalization Appliance and Mandibular Miniscrew Anchorage in Class II Malocclusion, sponsored by TC Erciyes University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 13 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by TC Erciyes University · Not applicable, Interventional, and Treatment
This study aimed to compare the dentoalveolar, skeletal, dental arch, transverse, and soft tissue effects of maxillary molar distalization performed with the Power Bar appliance using different mandibular anchorage methods, and to evaluate the additional effects of low-level laser therapy on orthodontic tooth movement.
A total of 57 participants were evaluated in four groups according to the anchorage approach used during treatment: miniscrew anchorage (n=14), orthodontic button anchorage (n=14), lingual arch anchorage (n=14), and a control group (n=15). In the three active treatment groups, maxillary molar distalization was performed using the Power Bar appliance. The treatment groups differed primarily according to the mandibular anchorage method used to support the distalization mechanics.
Low-level laser therapy was also evaluated within the active treatment groups using a split-mouth design. One side received low-level laser therapy, while the contralateral side did not receive laser application and served as an intra-individual comparison side. This design allowed the potential effect of laser therapy to be evaluated while reducing inter-individual variability.
Clinical and orthodontic records obtained before treatment (T0) and after the distalization period (T1) were compared. Skeletal, dentoalveolar, dental, dental arch, transverse, and soft tissue changes were assessed to determine the effects of the different anchorage methods and to investigate whether low-level laser therapy provided an additional effect during Power Bar-assisted maxillary molar distalization.
Class II malocclusion is a common orthodontic problem characterized by an anteroposterior discrepancy between the maxillary and mandibular dental arches and/or skeletal structures. In selected patients, distalization of the maxillary posterior teeth may be used to obtain or improve a Class I molar relationship and create space within the maxillary dental arch without extraction. The clinical effectiveness of distalization mechanics may be influenced by the type of anchorage system used, the magnitude and direction of the applied forces, and adjunctive methods intended to modify orthodontic tooth movement.
The Power Bar appliance is used to produce maxillary molar distalization through interarch mechanics. Because the reaction forces generated during distalization may affect the mandibular dentition and surrounding structures, the method used to provide mandibular anchorage may influence the dentoalveolar and skeletal effects of treatment. Therefore, this study compared different mandibular anchorage strategies used in conjunction with the Power Bar appliance.
A total of 57 participants were evaluated in four study groups. The active treatment groups consisted of a miniscrew anchorage group (n=14), an orthodontic button anchorage group (n=14), and a lingual arch anchorage group (n=14). A control group consisting of 15 participants was also included for comparison. Participants in the active treatment groups underwent maxillary molar distalization using the Power Bar appliance, while the mandibular anchorage method differed among the three treatment groups.
In addition to the comparison of anchorage methods, the potential effect of low-level laser therapy was investigated. Low-level laser therapy was evaluated using a split-mouth design within the active treatment groups. One side received laser application according to the study protocol, whereas the contralateral side did not receive laser therapy and served as an intra-individual control. The split-mouth approach was used to enable direct comparison of laser-treated and non-laser-treated sides within the same participant and to minimize the influence of individual biological variability.
Orthodontic records obtained before treatment (T0) and after completion of the distalization period (T1) were analyzed. Changes in skeletal, dentoalveolar, dental, dental arch, transverse, and soft tissue parameters were assessed. Comparisons were performed both between the different anchorage groups and between the laser-treated and non-laser-treated sides, where appropriate.
The primary objective of the study was to determine whether different mandibular anchorage methods used with the Power Bar appliance resulted in different treatment-related dentoalveolar and associated changes. A further objective was to evaluate whether adjunctive low-level laser therapy influenced the amount or pattern of orthodontic changes occurring during the distalization period. The study therefore provided a combined assessment of mechanical anchorage strategies and adjunctive laser therapy during Power Bar-assisted maxillary molar distalization.
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Participants aged 13 to 16 years. Skeletal Class I relationship suitable for treatment by maxillary molar distalization.
Bilateral dental Class II molar relationship requiring maxillary molar distalization, not exceeding approximately half a unit (3-4 mm).
Horizontal or normal vertical growth pattern (SN/GoGn ≤38°). Minimal to moderate crowding in the mandibular dental arch (\<5 mm). Absence of posterior crossbite in the maxillary arch. Fully erupted maxillary second permanent molars. Healthy periodontal tissues before orthodontic treatment. Good oral hygiene. Maxillary third molars positioned at or above the level of the trifurcation of the maxillary second molars.
No impacted tooth in the intended miniscrew insertion area. Ability and willingness of the participant and parent/legal guardian to comply with the study procedures and provide informed consent/assent.
Exclusion Criteria:
Requirement for orthodontic extraction treatment or functional orthopedic treatment.
Presence of systemic disease or a medical condition that could affect orthodontic treatment or tooth movement.
Pre-existing root resorption. Active periodontal or gingival disease before treatment. Previous orthodontic treatment. Known allergy to metals or materials used in the study. Temporomandibular joint disorders. Congenital or acquired craniofacial deformities involving the mandible or condyle.
Risk of bacterial endocarditis or another condition requiring special precautions during dental treatment.
Contraindication to low-level laser therapy. Contraindication to intraoral maxillary molar distalization. Inability to comply with the study protocol or scheduled follow-up visits.
Participants in this group underwent maxillary molar distalization using the Power Bar appliance with mandibular miniscrew anchorage. Low-level laser therapy was applied to one side using a split-mouth design, while the contralateral side served as the non-laser comparison side.
Device: Power Bar Distalization Appliance · Device: Mandibular Miniscrew Anchorage · Device: Low-Level Laser Therapy
Participants in this group underwent maxillary molar distalization using the Power Bar appliance with mandibular orthodontic button anchorage. Low-level laser therapy was applied to one side using a split-mouth design, while the contralateral side served as the non-laser comparison side.
Device: Power Bar Distalization Appliance · Device: Mandibular Orthodontic Button Anchorage · Device: Low-Level Laser Therapy
Participants in this group underwent maxillary molar distalization using the Power Bar appliance with mandibular lingual arch anchorage. Low-level laser therapy was applied to one side using a split-mouth design, while the contralateral side served as the non-laser comparison side.
Device: Power Bar Distalization Appliance · Device: Lingual Arch Anchorage Group · Device: Low-Level Laser Therapy
Participants in the control group did not receive Power Bar-assisted maxillary molar distalization, low-level laser therapy, or any of the study-specific anchorage interventions during the corresponding observation period. Their records were used as a comparison group to evaluate changes occurring without the study interventions.
The Power Bar appliance was used for bilateral maxillary molar distalization in the active treatment groups. The appliance was used in combination with different mandibular anchorage methods, including miniscrew anchorage, orthodontic button anchorage, and lingual arch anchorage.
Mandibular miniscrews were used as an anchorage method during Power Bar-assisted maxillary molar distalization to provide skeletal anchorage and reduce unwanted dental movements associated with the distalization mechanics.
Orthodontic buttons placed in the mandibular arch were used as the anchorage method during Power Bar-assisted maxillary molar distalization. The buttons provided dental anchorage for the interarch mechanics used during treatment.
A mandibular lingual arch was used as the anchorage method during Power Bar-assisted maxillary molar distalization. The lingual arch was used to reinforce mandibular dental anchorage during the distalization period.
Low-level laser therapy was applied during the maxillary molar distalization period using a split-mouth design. In each actively treated participant, one side received low-level laser therapy according to the study protocol, while the contralateral side did not receive laser application and served as the intra-individual comparison side.
Change in Maxillary First Molar Distalization
The amount of distal movement of the maxillary first molars (U6) was assessed using digital dental models obtained before treatment (T0) and after completion of the distalization phase (T1). The change in molar position was measured in millimeters and compared among the miniscrew, orthodontic button, lingual arch, and control groups. In the active treatment groups, laser-treated and non-laser-treated sides were also compared according to the split-mouth design.
Time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
Change in Maxillary Tooth Distalization
The distal movement of the maxillary canine, premolars, and second molar (U3, U4, U5, and U7) was measured on digital dental models obtained at baseline (T0) and after completion of the distalization phase (T1). Changes were recorded in millimeters and compared among the miniscrew, orthodontic button, lingual arch, and control groups. In the active treatment groups, the laser-treated and non-laser-treated sides were also compared.
Time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
Change in Maxillary Tooth Rotation
Rotational changes of the maxillary teeth (U3-U7) were evaluated on digital dental models obtained at T0 and T1. Rotation was measured in degrees. Changes were compared among the study groups and, in the active treatment groups, between the laser-treated and non-laser-treated sides.
Time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
Change in Maxillary Tooth Mesiodistal Tipping
Changes in the mesiodistal angulation of the maxillary teeth (U3-U7) were assessed using digital dental models obtained at T0 and T1. Tipping changes were expressed in degrees and compared among the four study groups. Side-specific comparisons were also performed between laser-treated and non-laser-treated sides in the active treatment groups.
Time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
Change in Transverse Dental Measurements
Transverse positional changes of the maxillary teeth were assessed on digital dental models obtained before treatment and after the distalization phase. Changes in transverse dental measurements were recorded in millimeters and compared among the miniscrew, orthodontic button, lingual arch, and control groups.
Time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
Change in Cephalometric Skeletal and Dentoalveolar Measurements
Skeletal and dentoalveolar changes were evaluated using lateral cephalometric records obtained at T0 and T1. Measurements included sagittal and vertical skeletal relationships, incisor and molar positions and inclinations, and overjet and overbite. Changes were compared among the miniscrew, orthodontic button, lingual arch, and control groups.
Time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
Change in Tooth Position Relative to the Third Palatal Ruga
Positional changes of selected maxillary teeth relative to the third palatal ruga reference line were evaluated on digital dental models obtained at T0 and T1. Changes were measured in millimeters to assess anteroposterior tooth movement during the distalization period.
Time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
Change in Soft Tissue Measurements
Soft tissue changes were assessed by comparing facial soft tissue records obtained before treatment (T0) and after completion of the distalization phase (T1). Changes in the evaluated soft tissue parameters were compared among the four study groups to determine the effects associated with the different anchorage methods.
Time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
Plan to share: No — Individual participant data will not be shared because an individual-level data sharing plan was not established in the study protocol. Study results will be reported in aggregate form.
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