Orthodontic Pain (D013850)ABB-PainRCTNCT07771920
Effect of Alpha Binaural Beat Music on Pain After Orthodontic Separator Placement
A study testing Alpha-Frequency Binaural Beat Music in people with Orthodontic Pain (D013850) and Anxiety, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Orthodontic pain is one of the most frequently reported adverse experiences during fixed appliance therapy and is particularly pronounced during the initial stages of treatment. Placement of orthodontic separators, a routine procedure performed to create interproximal space for orthodontic band placement, often causes… Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Orthodontic Pain (D013850), Anxiety
- What is being tested?
- Alpha-Frequency Binaural Beat Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Aug 2026to 18 Sep 2026
- 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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 15-30 years.
- Permanent dentition.
- Mild crowding (≤3 mm arch length discrepancy).
- Good periodontal health.
- Requirement for fixed orthodontic treatment.
- Requirement for bilateral maxillary first molar banding.
Show all 10Show fewer
- Requirement for placement of four elastomeric separators, consisting of one separator mesial and one separator distal to each maxillary first molar.
- Ability to understand study instructions and complete study assessments.
- Willingness to use stereo headphones.
- Provision of written informed consent.
Who cannot join
- Previous fixed orthodontic treatment.
- Congenital or acquired hearing impairment.
- Use of hearing aids or assistive listening devices.
- History of tinnitus, hyperacusis, or sound sensitivity.
- Active ear infection.
- Recent upper respiratory tract infection associated with ear symptoms.
Show all 14Show fewer
- Neurological disorders.
- Psychiatric disorders requiring treatment, including anxiety and depressive disorders.
- Current use of analgesics, anti-inflammatory medications, antidepressants, anxiolytics, antipsychotics, or sedatives.
- Chronic pain disorders.
- Active periodontal disease or significant gingival inflammation.
- Active dental pain, pulpal pathology, or oral infection.
- Inability or unwillingness to use stereo headphones.
- Inability to understand study instructions or complete study assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Aga Khan University Hospital
Karachi, Sindh, 74800
Muhammad Mughni, Bachelor of Dental Surgery, +923415882397, muhammad.mughni@aku.edu
Syed Muhammad Ali Gilani, Bachelor of Dental Surgery, +923317500883, ali.gilani@aku.edu
About this study
Official title: The Effect of Alpha Binaural Beat Music on Orthodontic Pain After Placement of Orthodontic Separators: A Randomized Controlled Trial
Orthodontic pain is one of the most frequently reported adverse experiences during fixed appliance therapy and is particularly pronounced during the initial stages of treatment. Placement of orthodontic separators, a routine procedure performed to create interproximal space for orthodontic band placement, often causes discomfort that may negatively influence patient motivation, treatment acceptance, and overall orthodontic experience. Psychological factors, particularly anxiety, may also influence pain perception and contribute to individual differences in pain responses during orthodontic treatment. Therefore, interventions that address both pain and anxiety may improve patient comfort and adaptation to treatment.
Binaural beats are auditory stimuli generated when two slightly different frequencies are presented separately to each ear, resulting in the perception of a third frequency equal to the difference between the two tones. Alpha-frequency binaural beats (8-13 Hz) have been associated with relaxation and reduced psychological arousal and have demonstrated promising analgesic and anxiolytic effects in various medical and dental settings. However, limited evidence exists regarding their role in the management of orthodontic pain following separator placement.
Read more
This prospective parallel-arm randomized controlled trial aims to evaluate the effect of alpha-frequency binaural beat stimulation on orthodontic pain and anxiety following separator placement. Seventy-two orthodontically treatment-naïve participants aged 15-30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), good periodontal health, and a requirement for fixed orthodontic treatment will be recruited from the orthodontic clinics of Aga Khan University Hospital, Karachi, Pakistan. To minimize potential confounding factors and standardize the painful stimulus, all participants will require bilateral maxillary first molar banding and placement of four elastomeric separators, consisting of one separator mesial and one separator distal to each maxillary first molar. Participants will be randomly allocated in a 1:1 ratio to either an intervention group receiving alpha-frequency binaural beat stimulation or a control group undergoing a standardized five-minute resting period without auditory stimulation.
The binaural beat intervention consists of an 11-Hz alpha-frequency stimulus generated through the presentation of a 285-Hz carrier tone to one ear and a 296-Hz carrier tone to the other ear. Participants assigned to the intervention group will listen to a standardized pre-recorded audio file through stereo headphones for five minutes at designated assessment intervals. Orthodontic pain intensity will be assessed using the Visual Analogue Scale for Pain (VAS-P), anxiety levels will be measured using the Visual Analogue Scale for Anxiety (VAS-A), and analgesic consumption will be recorded during the observation period. Assessments will be conducted before separator placement, during separator placement, and at 6, 24, and 48 hours following the procedure.
The primary objective of this study is to evaluate the effect of alpha-frequency binaural beat stimulation on orthodontic pain intensity 24 hours after separator placement. Secondary objectives include evaluating pain intensity at 6 and 48 hours, anxiety levels, and analgesic consumption during the 48-hour observation period. The findings of this study will provide evidence regarding the effectiveness of alpha-frequency binaural beats as a simple, inexpensive, safe, and non-pharmacological adjunct for reducing orthodontic pain and anxiety and improving patient comfort during the early stages of orthodontic treatment.
Read the detailed description
This study is a prospective, parallel-arm, randomized controlled clinical trial to be conducted at the Department of Dentistry and Oral Health Sciences, Aga Khan University Hospital, Karachi, Pakistan. The study aims to evaluate the effectiveness of alpha-frequency binaural beat auditory stimulation in reducing orthodontic pain and anxiety associated with orthodontic separator placement.
Orthodontic separators are routinely used during the initial stages of fixed orthodontic treatment to create interproximal space for orthodontic band placement. Although considered a routine orthodontic procedure, separator placement frequently causes discomfort and pain that may negatively affect patient motivation, treatment acceptance, compliance, and overall orthodontic experience. Psychological factors, particularly anxiety, have also been shown to influence pain perception and may contribute to variations in pain responses among orthodontic patients. Consequently, there is growing interest in safe and effective non-pharmacological approaches that may improve patient comfort while avoiding the potential adverse effects associated with analgesic medications.
Binaural beats are an auditory phenomenon produced when two slightly different sound frequencies are presented separately to each ear, resulting in the perception of a third frequency corresponding to the difference between the two tones. Alpha-frequency binaural beats, typically ranging between 8 and 13 Hz, have been associated with relaxation, reduced psychological stress, and decreased anxiety. Previous studies have suggested potential beneficial effects of binaural beats on pain perception and emotional responses; however, evidence regarding their effectiveness following orthodontic separator placement remains limited.
Orthodontically treatment-naïve participants aged 15 to 30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), good periodontal health, and a requirement for fixed orthodontic treatment will be screened for eligibility and recruited following informed consent procedures. To minimize potential confounding factors and standardize the painful stimulus across participants, all subjects will require bilateral maxillary first molar banding and placement of four elastomeric separators, consisting of one mesial and one distal separator around each maxillary first molar (two separators per side). Participants will be randomly allocated in a 1:1 ratio to either an intervention group or a control group.
The intervention group will receive alpha-frequency binaural beat stimulation through stereo headphones. The auditory stimulus will be generated by presenting a 285-Hz carrier frequency to one ear and a 296-Hz carrier frequency to the opposite ear, resulting in the perception of an 11-Hz alpha-frequency binaural beat. Participants will listen to a standardized audio track for five minutes at designated assessment intervals. Participants allocated to the control group will undergo an equivalent five-minute quiet resting period without auditory stimulation.
Orthodontic pain intensity will be assessed using the Visual Analogue Scale for Pain (VAS-P), while anxiety levels will be assessed using the Visual Analogue Scale for Anxiety (VAS-A). Outcome assessments will be performed before separator placement, during separator placement, and at 6, 24, and 48 hours following the procedure. Analgesic consumption during the observation period will also be recorded.
The primary objective of the study is to evaluate the effect of alpha-frequency binaural beat music on orthodontic pain intensity 24 hours after separator placement. Secondary objectives include evaluating orthodontic pain intensity at 6 and 48 hours, anxiety levels, and analgesic consumption during the observation period. The findings of this study may provide evidence regarding a simple, inexpensive, safe, and non-pharmacological adjunct that could improve patient comfort, reduce procedure-related anxiety, and enhance the overall orthodontic treatment experience during the initial stages of orthodontic care.
- Conditions
- Orthodontic Pain (D013850), Anxiety
- Being tested
- Alpha-Frequency Binaural Beat Music
- Keywords
- Orthodontics, Orthodontic Appliances, Orthodontic Pain, Pain Measurement, Acoustic Stimulation, Anxiety, Orthodontic Separators, Alpha Binaural Beats, Music Therapy, Nonpharmacological Pain Management
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Frequency Binaural Beat MusicBehavioural
Also called 11-Hz Alpha Binaural Beat Audio Stimulation, Alpha Binaural Beat Music
Participants assigned to the intervention group will receive alpha-frequency binaural beat auditory stimulation through stereo headphones following orthodontic separator placement. The auditory stimulus will be generated by presenting a 285-Hz carrier frequency to one ear and a 296-Hz carrier frequency to the opposite ear, resulting in the perception of an 11-Hz binaural beat within the alpha frequency range. Participants will listen to the standardized audio stimulus for five minutes at designated assessment intervals during the 48-hour observation period following separator placement.
| Study group | Role | What they receive |
|---|---|---|
| Alpha Binaural Beat Music | Experimental | Participants aged 15-30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), good periodontal health, and no history of previous fixed orthodontic treatment will undergo standardized bilateral maxillary first molar separator placement using four elastomeric separators, with one separator placed mesial and one separator placed distal to each maxillary first molar. Participants assigned to this arm will receive alpha-frequency binaural beat auditory stimulation through stereo headphones for five minutes at designated assessment intervals. Orthodontic pain intensity, anxiety levels, and analgesic consumption will be evaluated during the 48-hour observation period following separator placement. Receives: Behavioral: Alpha-Frequency Binaural Beat Music |
| Control | No intervention | Participants aged 15-30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), good periodontal health, and no history of previous fixed orthodontic treatment will undergo standardized bilateral maxillary first molar separator placement using four elastomeric separators, with one separator placed mesial and one separator placed distal to each maxillary first molar. Participants allocated to this arm will undergo a standardized five-minute quiet resting period without auditory stimulation. Orthodontic pain intensity, anxiety levels, and analgesic consumption will be evaluated during the 48-hour observation period following separator placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthodontic Pain Intensity
Orthodontic pain intensity measured using the Visual Analogue Scale for Pain (VAS-P). Scores range from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: 24 hours after orthodontic separator placement
Secondary outcomes (5)
Orthodontic Pain Intensity at 6 Hours
Orthodontic pain intensity measured using the Visual Analogue Scale for Pain (VAS-P). Scores range from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: 6 hours after orthodontic separator placement
Orthodontic Pain Intensity at 48 Hours
Orthodontic pain intensity measured using the Visual Analogue Scale for Pain (VAS-P). Scores range from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: 48 hours after orthodontic separator placement
Orthodontic Pain Intensity During Separator Placement
Orthodontic pain intensity measured using the Visual Analogue Scale for Pain (VAS-P). Scores range from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: Periprocedural (during orthodontic separator placement)
Anxiety Level
Anxiety measured using the Visual Analogue Scale for Anxiety (VAS-A). Scores range from 0 (no anxiety) to 10 (worst imaginable anxiety). Higher scores indicate greater anxiety.
Measured: Baseline, periprocedural, 6 hours, 24 hours, and 48 hours after orthodontic separator placement
Analgesic Consumption
Number of analgesic tablets consumed during the observation period following orthodontic separator placement.
Measured: Through 48 hours after orthodontic separator placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start3 Aug 2026 (estimated)
- Primary completion16 Sep 2026 (estimated)
- Study completion18 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Pain (D013850)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective randomized controlled trial uses a parallel-group design. Orthodontically treatment-naïve participants aged 15-30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), and good periodontal health will be randomly allocated in a 1:1 ratio to either an alpha-frequency binaural beat intervention group or a control group. All participants will undergo standardized bilateral maxillary first molar separator placement using four elastomeric separators. Orthodontic pain intensity, anxiety levels, and analgesic consumption will be assessed over a 48-hour observation period.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771920
- Sponsor's protocol ID
- 2026-12625-42313
- Acronym
- ABB-PainRCT
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 19 Aug 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 made publicly available. The study is a single-center investigator-initiated trial, and sharing of individual participant data is restricted to protect participant confidentiality and comply with institutional policies and ethics requirements.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alpha Binaural Beat Music on Orthodontic Pain After Placement of Orthodontic Separators: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07771920
- Acronym / sponsor ID
- ABB-PainRCT / 2026-12625-42313
- Conditions
- Orthodontic Pain (D013850), Anxiety
- Keywords
- Orthodontics, Orthodontic Appliances, Orthodontic Pain, Pain Measurement, Acoustic Stimulation, Anxiety, Orthodontic Separators, Alpha Binaural Beats
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 16 Sep 2026 (estimated)
- Study completion
- 18 Sep 2026 (estimated)
- First posted
- 19 Aug 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.
Orthodontic pain is one of the most frequently reported adverse experiences during fixed appliance therapy and is particularly pronounced during the initial stages of treatment. Placement of orthodontic separators, a routine procedure performed to create interproximal space for orthodontic band placement, often causes discomfort that may negatively influence patient motivation, treatment acceptance, and overall orthodontic experience. Psychological factors, particularly anxiety, may also influence pain perception and contribute to individual differences in pain responses during orthodontic treatment. Therefore, interventions that address both pain and anxiety may improve patient comfort and adaptation to treatment.
Binaural beats are auditory stimuli generated when two slightly different frequencies are presented separately to each ear, resulting in the perception of a third frequency equal to the difference between the two tones. Alpha-frequency binaural beats (8-13 Hz) have been associated with relaxation and reduced psychological arousal and have demonstrated promising analgesic and anxiolytic effects in various medical and dental settings. However, limited evidence exists regarding their role in the management of orthodontic pain following separator placement.
This prospective parallel-arm randomized controlled trial aims to evaluate the effect of alpha-frequency binaural beat stimulation on orthodontic pain and anxiety following separator placement. Seventy-two orthodontically treatment-naïve participants aged 15-30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), good periodontal health, and a requirement for fixed orthodontic treatment will be recruited from the orthodontic clinics of Aga Khan University Hospital, Karachi, Pakistan. To minimize potential confounding factors and standardize the painful stimulus, all participants will require bilateral maxillary first molar banding and placement of four elastomeric separators, consisting of one separator mesial and one separator distal to each maxillary first molar. Participants will be randomly allocated in a 1:1 ratio to either an intervention group receiving alpha-frequency binaural beat stimulation or a control group undergoing a standardized five-minute resting period without auditory stimulation.
The binaural beat intervention consists of an 11-Hz alpha-frequency stimulus generated through the presentation of a 285-Hz carrier tone to one ear and a 296-Hz carrier tone to the other ear. Participants assigned to the intervention group will listen to a standardized pre-recorded audio file through stereo headphones for five minutes at designated assessment intervals. Orthodontic pain intensity will be assessed using the Visual Analogue Scale for Pain (VAS-P), anxiety levels will be measured using the Visual Analogue Scale for Anxiety (VAS-A), and analgesic consumption will be recorded during the observation period. Assessments will be conducted before separator placement, during separator placement, and at 6, 24, and 48 hours following the procedure.
The primary objective of this study is to evaluate the effect of alpha-frequency binaural beat stimulation on orthodontic pain intensity 24 hours after separator placement. Secondary objectives include evaluating pain intensity at 6 and 48 hours, anxiety levels, and analgesic consumption during the 48-hour observation period. The findings of this study will provide evidence regarding the effectiveness of alpha-frequency binaural beats as a simple, inexpensive, safe, and non-pharmacological adjunct for reducing orthodontic pain and anxiety and improving patient comfort during the early stages of orthodontic treatment.
Detailed description
This study is a prospective, parallel-arm, randomized controlled clinical trial to be conducted at the Department of Dentistry and Oral Health Sciences, Aga Khan University Hospital, Karachi, Pakistan. The study aims to evaluate the effectiveness of alpha-frequency binaural beat auditory stimulation in reducing orthodontic pain and anxiety associated with orthodontic separator placement.
Orthodontic separators are routinely used during the initial stages of fixed orthodontic treatment to create interproximal space for orthodontic band placement. Although considered a routine orthodontic procedure, separator placement frequently causes discomfort and pain that may negatively affect patient motivation, treatment acceptance, compliance, and overall orthodontic experience. Psychological factors, particularly anxiety, have also been shown to influence pain perception and may contribute to variations in pain responses among orthodontic patients. Consequently, there is growing interest in safe and effective non-pharmacological approaches that may improve patient comfort while avoiding the potential adverse effects associated with analgesic medications.
Binaural beats are an auditory phenomenon produced when two slightly different sound frequencies are presented separately to each ear, resulting in the perception of a third frequency corresponding to the difference between the two tones. Alpha-frequency binaural beats, typically ranging between 8 and 13 Hz, have been associated with relaxation, reduced psychological stress, and decreased anxiety. Previous studies have suggested potential beneficial effects of binaural beats on pain perception and emotional responses; however, evidence regarding their effectiveness following orthodontic separator placement remains limited.
Orthodontically treatment-naïve participants aged 15 to 30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), good periodontal health, and a requirement for fixed orthodontic treatment will be screened for eligibility and recruited following informed consent procedures. To minimize potential confounding factors and standardize the painful stimulus across participants, all subjects will require bilateral maxillary first molar banding and placement of four elastomeric separators, consisting of one mesial and one distal separator around each maxillary first molar (two separators per side). Participants will be randomly allocated in a 1:1 ratio to either an intervention group or a control group.
The intervention group will receive alpha-frequency binaural beat stimulation through stereo headphones. The auditory stimulus will be generated by presenting a 285-Hz carrier frequency to one ear and a 296-Hz carrier frequency to the opposite ear, resulting in the perception of an 11-Hz alpha-frequency binaural beat. Participants will listen to a standardized audio track for five minutes at designated assessment intervals. Participants allocated to the control group will undergo an equivalent five-minute quiet resting period without auditory stimulation.
Orthodontic pain intensity will be assessed using the Visual Analogue Scale for Pain (VAS-P), while anxiety levels will be assessed using the Visual Analogue Scale for Anxiety (VAS-A). Outcome assessments will be performed before separator placement, during separator placement, and at 6, 24, and 48 hours following the procedure. Analgesic consumption during the observation period will also be recorded.
The primary objective of the study is to evaluate the effect of alpha-frequency binaural beat music on orthodontic pain intensity 24 hours after separator placement. Secondary objectives include evaluating orthodontic pain intensity at 6 and 48 hours, anxiety levels, and analgesic consumption during the observation period. The findings of this study may provide evidence regarding a simple, inexpensive, safe, and non-pharmacological adjunct that could improve patient comfort, reduce procedure-related anxiety, and enhance the overall orthodontic treatment experience during the initial stages of orthodontic care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This prospective randomized controlled trial uses a parallel-group design. Orthodontically treatment-naïve participants aged 15-30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), and good periodontal health will be randomly allocated in a 1:1 ratio to either an alpha-frequency binaural beat intervention group or a control group. All participants will undergo standardized bilateral maxillary first molar separator placement using four elastomeric separators. Orthodontic pain intensity, anxiety levels, and analgesic consumption will be assessed over a 48-hour observation period.
| Arm | Type | Receives |
|---|---|---|
| Alpha Binaural Beat Music | Experimental | Behavioral: Alpha-Frequency Binaural Beat MusicParticipants aged 15-30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), good periodontal health, and no history of previous fixed orthodontic treatment will undergo standardized bilateral maxillary first molar separator placement using four elastomeric separators, with one separator placed mesial and one separator placed distal to each maxillary first molar. Participants assigned to this arm will receive alpha-frequency binaural beat auditory stimulation through stereo headphones for five minutes at designated assessment intervals. Orthodontic pain intensity, anxiety levels, and analgesic consumption will be evaluated during the 48-hour observation period following separator placement. |
| Control | No intervention | –Participants aged 15-30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), good periodontal health, and no history of previous fixed orthodontic treatment will undergo standardized bilateral maxillary first molar separator placement using four elastomeric separators, with one separator placed mesial and one separator placed distal to each maxillary first molar. Participants allocated to this arm will undergo a standardized five-minute quiet resting period without auditory stimulation. Orthodontic pain intensity, anxiety levels, and analgesic consumption will be evaluated during the 48-hour observation period following separator placement. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Patients aged 15-30 years.
- Permanent dentition.
- Mild crowding (≤3 mm arch length discrepancy).
- Good periodontal health.
- Requirement for fixed orthodontic treatment.
Key exclusion criteria (14 listed)
- Previous fixed orthodontic treatment.
- Congenital or acquired hearing impairment.
- Use of hearing aids or assistive listening devices.
- History of tinnitus, hyperacusis, or sound sensitivity.
- Active ear infection.
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 |
|---|---|---|
| Alpha-Frequency Binaural Beat MusicAlso: 11-Hz Alpha Binaural Beat Audio Stimulation, Alpha Binaural Beat MusicParticipants assigned to the intervention group will receive alpha-frequency binaural beat auditory stimulation through stereo headphones following orthodontic separator placement. The auditory stimulus will be generated by presenting a 285-Hz carrier frequency to one ear and a 296-Hz carrier frequency to the opposite ear, resulting in the perception of an 11-Hz binaural beat within the alpha frequency range. Participants will listen to the standardized audio stimulus for five minutes at designated assessment intervals during the 48-hour observation period following separator placement. | Behavioural | Alpha Binaural Beat Music |
Primary outcome
Orthodontic Pain Intensity
Time frame: 24 hours after orthodontic separator placement
Orthodontic pain intensity measured using the Visual Analogue Scale for Pain (VAS-P). Scores range from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
5 secondary outcomes
Orthodontic Pain Intensity at 6 Hours
Time frame: 6 hours after orthodontic separator placement
Orthodontic Pain Intensity at 48 Hours
Time frame: 48 hours after orthodontic separator placement
Orthodontic Pain Intensity During Separator Placement
Time frame: Periprocedural (during orthodontic separator placement)
Anxiety Level
Time frame: Baseline, periprocedural, 6 hours, 24 hours, and 48 hours after orthodontic separator placement
Analgesic Consumption
Time frame: Through 48 hours after orthodontic separator placement
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 19 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available. The study is a single-center investigator-initiated trial, and sharing of individual participant data is restricted to protect participant confidentiality and comply with institutional policies and ethics requirements.
Related trials for Orthodontic Pain (D013850)
Not yet recruiting
Comparison of Three Orthodontic Separators for Pain, Plaque, and Tooth Separation
Orthodontic Pain (D013850), Malocclusion
Active, not recruitingPhase 1
Efficacy of Selective COX-2 Inhibitors in Relieving Orthodontic Pain
Orthodontic Pain (D013850)
Not yet recruitingPhase 1
A Randomized Clinical Trial of the Effectiveness of Acupressure in Relieving Orthodontic Pain
Orthodontic Pain (D013850), Pain Management (D016146)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha-Frequency Binaural Beat Music in people with Orthodontic Pain (D013850) and Anxiety, run by Aga Khan University at 1 site in Pakistan.
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 10 inclusion and 14 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 19 Aug 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 Pakistan. 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?
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?
Contact Muhammad Mughni, BDS (+923415882397, muhammad.mughni@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthodontic Pain Intensity (time frame: 24 hours after orthodontic separator placement). 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 19 Aug 2026.