Class II MalocclusionNCT07888231
Effects of Different Anchorage Methods and Low-Level Laser Therapy in Power Bar Distalization
A study testing Power Bar Distalization Appliance, Mandibular Miniscrew Anchorage and Mandibular Orthodontic Button Anchorage in people with Class II Malocclusion, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- Power Bar Distalization Appliance, Mandibular Miniscrew Anchorage and Mandibular Orthodontic Button Anchorage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2025to 30 Jun 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 13 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Faculty of Dentistry, Department of Orthodontics
Kayseri, Kayseri, 38039
About this study
Official title: Comparison of the Effects of Power Bar Appliance Distalization Treatment Using Different Anchorage Methods and Low-Level Laser Therapy on Dentoalveolar Structures and Soft Tissues
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Class II Malocclusion
- Being tested
- Power Bar Distalization Appliance, Mandibular Miniscrew Anchorage, Mandibular Orthodontic Button Anchorage, Lingual Arch Anchorage Group, Low-Level Laser Therapy
- Keywords
- Orthodontics, Class II Malocclusion, Maxillary Molar Distalization, Power Bar Appliance, Miniscrew Anchorage, Lingual Arch, Orthodontic Anchorage, Low-Level Laser Therapy, Dentoalveolar Changes, Soft Tissue Changes
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power Bar Distalization ApplianceDevice
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 Miniscrew AnchorageDevice
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.
Mandibular Orthodontic Button AnchorageDevice
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.
Lingual Arch Anchorage GroupDevice
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Miniscrew Anchorage Group | Experimental | 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. Receives: Device: Power Bar Distalization Appliance; Device: Mandibular Miniscrew Anchorage; Device: Low-Level Laser Therapy |
| Orthodontic Button Anchorage Group | Experimental | 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. Receives: Device: Power Bar Distalization Appliance; Device: Mandibular Orthodontic Button Anchorage; Device: Low-Level Laser Therapy |
| Lingual Arch Anchorage Group | Experimental | 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. Receives: Device: Power Bar Distalization Appliance; Device: Lingual Arch Anchorage Group; Device: Low-Level Laser Therapy |
| No Intervention | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start10 Sep 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II MalocclusionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to parallel study groups according to the mandibular anchorage method used during Power Bar-assisted maxillary molar distalization. The active treatment groups included miniscrew anchorage, orthodontic button anchorage, and lingual arch anchorage. A control group was included for comparison. In addition, low-level laser therapy was evaluated using a split-mouth design within the active treatment groups, with one side receiving laser therapy and the contralateral side serving as the non-laser comparison side.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahım Yavuz, TC Erciyes University
- Investigators
- ibrahim yavuz, DDS, PhD, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888231
- Sponsor's protocol ID
- ERU-2025-250
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Power Bar Appliance Distalization Treatment Using Different Anchorage Methods and Low-Level Laser Therapy on Dentoalveolar Structures and Soft Tissues
- ClinicalTrials.gov ID
- NCT07888231
- Acronym / sponsor ID
- ERU-2025-250
- Conditions
- Class II Malocclusion
- Keywords
- Orthodontics, Class II Malocclusion, Maxillary Molar Distalization, Power Bar Appliance, Miniscrew Anchorage, Lingual Arch, Orthodontic Anchorage, Low-Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 22 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants were assigned to parallel study groups according to the mandibular anchorage method used during Power Bar-assisted maxillary molar distalization. The active treatment groups included miniscrew anchorage, orthodontic button anchorage, and lingual arch anchorage. A control group was included for comparison. In addition, low-level laser therapy was evaluated using a split-mouth design within the active treatment groups, with one side receiving laser therapy and the contralateral side serving as the non-laser comparison side.
| Arm | Type | Receives |
|---|---|---|
| Miniscrew Anchorage Group | Experimental | Device: Power Bar Distalization Appliance, Device: Mandibular Miniscrew Anchorage, Device: Low-Level Laser TherapyParticipants 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. |
| Orthodontic Button Anchorage Group | Experimental | Device: Power Bar Distalization Appliance, Device: Mandibular Orthodontic Button Anchorage, Device: Low-Level Laser TherapyParticipants 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. |
| Lingual Arch Anchorage Group | Experimental | Device: Power Bar Distalization Appliance, Device: Lingual Arch Anchorage Group, Device: Low-Level Laser TherapyParticipants 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. |
| No Intervention | No intervention | –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. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Power Bar Distalization ApplianceThe 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. | Device | Lingual Arch Anchorage Group, Miniscrew Anchorage Group, Orthodontic Button Anchorage Group |
| Mandibular Miniscrew AnchorageMandibular 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. | Device | Miniscrew Anchorage Group |
| Mandibular Orthodontic Button AnchorageOrthodontic 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. | Device | Orthodontic Button Anchorage Group |
| Lingual Arch Anchorage GroupA 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. | Device | Lingual Arch Anchorage Group |
| Low-Level Laser TherapyLow-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. | Device | Lingual Arch Anchorage Group, Miniscrew Anchorage Group, Orthodontic Button Anchorage Group |
Primary outcome
Change in Maxillary First Molar Distalization
Time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
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.
7 secondary outcomes
Change in Maxillary Tooth Distalization
Time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
Change in Maxillary Tooth Rotation
Time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
Change in Maxillary Tooth Mesiodistal Tipping
Time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
Change in Transverse Dental Measurements
Time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
Change in Cephalometric Skeletal and Dentoalveolar Measurements
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
Time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
Change in Soft Tissue Measurements
Time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).
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 22 Oct 2026.
- Individual participant dataSharing planned: 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.
Related trials for Class II Malocclusion
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Malocclusion, Class II Malocclusion
Recruiting
Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates
Malocclusion, Angle Class II
Recruiting
Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners
Malocclusion of Anterior Teeth, Malocclusion in Children
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.
ibrahim yavuz, DDS, PhD principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power Bar Distalization Appliance, Mandibular Miniscrew Anchorage and Mandibular Orthodontic Button Anchorage in people with Class II Malocclusion, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 22 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 Turkey (Türkiye). 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?
Change in Maxillary First Molar Distalization (time frame: Baseline (before treatment) and completion of the distalization phase (mean 6.5 months after baseline).). 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 22 Oct 2026.