Clinical Research Directory

Effect of Alpha Binaural Beat Music on Pain After Orthodontic Separator Placement

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.

Comparison of Three Orthodontic Separators for Pain, Plaque, and Tooth Separation

Orthodontic separators are small devices placed between teeth before fitting braces to create space for bands. This procedure may cause pain, discomfort, and changes in oral hygiene, which can affect plaque buildup and daily activities. This study aims to compare three commonly used types of orthodontic separators-elastomeric, Kesling, and customized tie wire separators-in terms of the amount of tooth separation achieved, pain experienced by patients, and plaque accumulation. In addition, the study will assess how these separators affect patients' quality of life, including eating, speaking, and daily comfort. Participants will be assigned to one of the three separator types and will be evaluated after 48 to 72 hours. The findings of this study may help identify the most effective and comfortable separator, improving patient care and treatment experience in orthodontics.

A Randomized Clinical Trial of the Effectiveness of Acupressure in Relieving Orthodontic Pain

Orthodontic treatment with fixed appliances often causes pain, which peaks within 24 hours after archwire placement and lasts for several days. Patients commonly use analgesics such as acetaminophen to relieve pain, as it has minimal impact on tooth movement compared to NSAIDs. However, nonpharmacological approaches, such as acupressure, may offer an alternative method for pain relief. Acupressure is a traditional Chinese medicine technique that involves applying pressure to specific points on the body to reduce pain and promote relaxation. This randomized clinical trial aims to compare the effectiveness of acupressure versus acetaminophen in relieving orthodontic pain during the first five days after initial archwire placement. Study Design and Methodology * A parallel-group, single-center, blinded, randomized trial at Almina Dental Clinics. * Participants will be randomly assigned to one of two groups (1:1 ratio): 1. Acetaminophen Group: Participants will take 500 mg of acetaminophen up to three times in the first 24 hours after archwire insertion. 2. Acupressure Group: Participants will apply pressure on two acupressure points (St 6 and St 3) up to five times in the first 24 hours. If pain persists, they may take acetaminophen. * Pain levels will be recorded using a Visual Analog Scale (VAS) twice daily for five days. * The Mann-Whitney U test will be used to compare pain scores between groups. Eligibility Criteria Inclusion Criteria: * Patients aged 12 years and older with full permanent dentition (excluding third molars). * Undergoing fixed orthodontic treatment for the first time. * Minimum crowding of 4 mm according to Little's Irregularity Index. * No systemic diseases, periodontal diseases, or acute/chronic oral pain. Exclusion Criteria: * Chronic use of analgesic medications. * Allergy or contraindications to acetaminophen. * Pregnant patients or those with cleft lip/palate. * Recent toothache or requiring tooth extractions. * Female patients during their menstrual period. Study Significance This study evaluates whether acupressure can be an effective, nonpharmacological alternative to acetaminophen for managing orthodontic pain. If proven effective, acupressure could offer a safe, noninvasive method for pain relief with fewer side effects. Ethical Considerations \& Dissemination * The study protocol will be reviewed and approved by an ethics committee. * The research is self-funded. * Results will be published in a scientific journal to contribute to orthodontic pain management research.