Chewing Gum Effect in Reducing Orthodontic Pain After Separator and Initial Arch Wire Placement

Study Overview
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Brief Summary
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Pain is the most claimed complaint from orthodontic treatment. Fear of pain has contributed to patients' avoidance of seeking orthodontic treatment, affects patients' compliance to treatment and even becomes the main reason for discontinuing orthodontic treatment. For years, orthodontic patients have reported using analgesics during orthodontic treatment to ease the pain. However, analgesics have many side effects such as allergic reactions, bleeding disorders, gastric ulcers, liver toxicity and their potential influence in slowing down tooth movement. This study aimed to investigate the effectiveness of chewing gums in pain reduction in Malaysian multi-ethnic orthodontic patients and to explore the possibility of chewing gum to be recommended as a suitable substitute for analgesics in our future practice.

Detailed Description
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Orthodontic treatment have been shown to cause varying degrees of discomforts and pain to the patients. Fear of pain has contributed to patients' avoidance of seeking orthodontic treatment, affect patients' compliance to the treatment and even become a main reason of discontinuing orthodontic treatment. Patients have reported using of analgesic particularly NSAIDS and Paracetamol during orthodontic treatment to ease the pain. However, NSAIDS have been associated with various side effects such as allergic reactions, bleeding disorders and gastric ulcers had raised the concern of orthodontists. Studies on animals have shown that NSAIDS slower the rate of tooth movement, hence affecting orthodontic treatment efficacy. Paracetamol have been reported to cause liver toxicity in the case of over dosage. The action of chewing the gum can produce forces to temporary displace the teeth sufficiently to allow blood flow through compressed area, preventing the build-up of metabolic products, thus reduce the pain severity. In addition, non-sugared chewing gum has anti-caries effect which is very important to prevent caries formation during orthodontic treatment. This study aimed to investigate the effectiveness of chewing gum in pain reduction in orthodontic patients and to explore the possibility of chewing gum to be recommended as a suitable substitute for analgesics in future practice.

Official Title
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The Effect of the Chewing Gum in Alleviating Orthodontic Pain After Separator and Initial Arch Wire Placement: A Randomized Clinical Trial

Conditions
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Orthodontic Pain

Intervention / Treatment
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* Other: Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients about to undergo orthodontic treatment with maxillary and mandibular fixed appliances Orthodontic treatment include the extraction of the permanent first or second premolars Age 16 years and above Exclusion Criteria: Significant medical problem or cleft lip and palate. Pregnant lady Occurrence of using analgesics or antibiotics History of asthma or unstable asthma the last year Oral surgery in the previous 4 weeks

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Method of randomization using online randomization software. All 108 participants will be randomly allocated into 2 groups with a 1:1 allocation. Participants will be grouped into either group 1 (Intervention group, chewing gum) or group 2 (Control group, no chewing gum given) by using block randomization with block size of 4. Each group will have 54 participants. Concealment of the allocation sequence will be done by concealing the sequence in opaque envelopes.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Participants will receive Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum. They will be instructed to chew the gum for pain relief after the separator and initial arch wire placement if required. Chew the gums for 10-12 minutes and as much as they want whenever they feel discomfort or pain. They are free to take any medication when necessary and respond to the questionnaires on the amount of chewing gum and analgesics used. | Other: Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum<br>* Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum 65g 40 pieces<br>|
| No Intervention: Control group<br>Participants will not receive any prescription after the separators and initial arch wires placement. They will be specifically asked not to chew chewing gum. As in the intervention group, they can take any medication when they feel necessary and respond to the questionnaires on the amount of analgesics used. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment after separators and initial arch wire placement. | Level of pain on the Numerical pain rating scale (NRS) | At 6 hours after separators and initial arch wire placement. | 
| Pain assessment after separators and initial arch wire placement. | Level of pain on the Numerical pain rating scale (NRS) | At 24 hours after separators and initial arch wire placement. | 
| Pain assessment after separators and initial arch wire placement. | Level of pain on the Numerical pain rating scale (NRS) | At 48 hours after separators and initial arch wire placement. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported use of chewing gum and analgesics. | Amount of chewing gums and medications consumed after the separator and initial arch wire placement | Immediately after the separator and archwire placements until up to 6 hours | 
| Reported use of chewing gum and analgesics. | Amount of chewing gums and medications consumed after the separator and initial arch wire placement | from 6 hours to 24 hours after the separator and archwire placements | 
| Reported use of chewing gum and analgesics. | Amount of chewing gums and medications consumed after the separator and initial arch wire placement | from 24 hours to 48 hours after the separator and archwire placements | 
| Recorded appliances breakages. | Frequency of appliances breakages | Immediately after the separator and archwire placements until 2 days after the separator and archwire placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chewing gum, Orthodontic pain