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The goal of this clinical trial is to find out which method works best to reduce pain after braces are adjusted for the first time (when the first archwire is placed). The study will compare three approaches: acupressure (applying pressure on a specific point on the hand), ibuprofen (a pain-relief medicine), and chewing sugar-free gum. It will also check how safe these methods are and whether patients need extra pain medicine.
The main questions the researchers want to answer are:
Which method reduces orthodontic pain the most after the first archwire is placed? Do patients need extra painkillers in any of the groups? Are there any problems with braces (such as loose brackets or wire issues) within the first week?
Researchers will compare the three groups to see which option gives the best pain relief during the first few days after braces are activated.
Participants will:
Be placed into one of three groups: acupressure, ibuprofen, or chewing gum Use their assigned method after their first orthodontic wire is placed Rate their pain at different time points using a simple pain scale (VAS) Report if they take any extra pain medicine Be checked for any brace-related problems for up to 7 days
This study may help improve comfort and pain management for patients starting orthodontic treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupressure Intervention | Experimental | Participants in this arm will receive instructions on the use of acupressure for orthodontic pain management following placement of the initial archwire. Verbal instructions and a standardized advice sheet will be provided. Participants will be trained to apply steady, perpendicular pressure using the thumb of the opposite hand to the LI4 (Hegu) acupressure point for approximately 3 minutes. The location of the LI4 point will be demonstrated and identified as the point on the dorsum of the hand between the first and second metacarpal bones, at the midpoint of the second metacarpal bone near its radial border. Participants will be instructed to perform acupressure according to the standardized study protocol. |
|
| Ibuprofen Intervention | Active Comparator | In the ibuprofen group participants will be provided with a 400 mg oral dose post arch wire placement. With a minimum gap of 8 hours between doses, remaining doses will be taken as per need for the relief of pain with the total daily dose not surpassing 1200 mg. |
|
| Chewing Gum Intervention | Experimental | Instructions to chew sugar-free gum for a period of 10 minutes immediately post arch wire placement will be provided to the chewing gum group, 8 hourly, for pain relief. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupressure | Behavioral | Participants in this arm will receive instructions on the use of acupressure for orthodontic pain management following placement of the initial archwire. Verbal instructions and a standardized advice sheet will be provided. Participants will be trained to apply steady, perpendicular pressure using the thumb of the opposite hand to the LI4 (Hegu) acupressure point for approximately 3 minutes. The location of the LI4 point will be demonstrated and identified as the point on the dorsum of the hand between the first and second metacarpal bones, at the midpoint of the second metacarpal bone near its radial border. Participants will be instructed to perform acupressure according to the standardized study protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-archwire orthodontic pain | Pain experienced by patients following placement of the initial orthodontic archwire, measured using the Visual Analog Scale (VAS). | Pain levels will be recorded using a 10-cm visual analog scale (vas) at the following intervals: • 2 hours • 6 hours • Bedtime (day 1) • 24 hours (day 2) • Day 3 • Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue analgesic consumption | Use of any additional analgesic medication beyond the assigned intervention. | Within 7 days following initial archwire placement. |
| Appliance-related complications |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D019050 | Acupressure |
| D007052 | Ibuprofen |
| D002638 | Chewing Gum |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Participants will be randomly assigned to one of three parallel groups: acupressure, ibuprofen, or chewing gum. Each group will receive a different intervention following placement of the initial orthodontic archwire, and outcomes will be assessed independently without crossover between groups.
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| Ibuprofen 400 mg (if necessary) | Drug | In the ibuprofen group participants will be provided with a 400 mg oral dose post arch wire placement. With a minimum gap of 8 hours between doses, remaining doses will be taken as per need for the relief of pain with the total daily dose not surpassing 1200 mg. |
|
| Chewing Gum | Behavioral | Instructions to chew sugar-free gum for a period of 10 minutes immediately post arch wire placement will be provided to the chewing gum group, 8 hourly, for pain relief. |
|
Mechanical issues occurring such as bracket debonding or wire displacement.
| Within 7 days following initial archwire placement. |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |