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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | 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. |
|
| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum | Other | Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum 65g 40 pieces |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Poon Pei San | Contact | 0127691145 | peisanpss@gmail.com | |
| Siti Adibah Othman, Prof | Contact | 012-2635088 | sitiadibah@um.edu.my |
| Name | Affiliation | Role |
|---|---|---|
| Siti Adibah Othman, Prof | Faculty of Dentistry, University of Malaya | Study Director |
| Zamros Yuzadi Mohd Yusof, Prof | Faculty Of Dentistry, University of Malaya | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Postgraduate Orthodontic Clinic, Faculty of Dentistry, University Malaya | Recruiting | Kuala Lumpur | Kuala Lumpur | 50603 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22812440 | Background | Benson PE, Razi RM, Al-Bloushi RJ. The effect of chewing gum on the impact, pain and breakages associated with fixed orthodontic appliances: a randomized clinical trial. Orthod Craniofac Res. 2012 Aug;15(3):178-87. doi: 10.1111/j.1601-6343.2012.01546.x. Epub 2012 Jun 22. | |
| 27476354 | Background | Ireland AJ, Ellis P, Jordan A, Bradley R, Ewings P, Atack NE, Griffiths H, House K, Moore M, Deacon S, Wenger N, Worth V, Scaysbrook E, Sandy JR. Comparative assessment of chewing gum and ibuprofen in the management of orthodontic pain with fixed appliances: A pragmatic multicenter randomized controlled trial. Am J Orthod Dentofacial Orthop. 2016 Aug;150(2):220-7. doi: 10.1016/j.ajodo.2016.02.018. |
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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.
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Blinding of participants is not possible during allocation, treatment and data collection. However, blinding can be done during data processing, analysing and data collection for secondary outcome on appliances failure rate.
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 |
| Poon Pei San |
| Faculty of dentistry, University of Malaya |
| Principal Investigator |
| 8893104 | Background | Kehoe MJ, Cohen SM, Zarrinnia K, Cowan A. The effect of acetaminophen, ibuprofen, and misoprostol on prostaglandin E2 synthesis and the degree and rate of orthodontic tooth movement. Angle Orthod. 1996;66(5):339-49. doi: 10.1043/0003-3219(1996)0662.3.CO;2. |
| 20578865 | Background | Xiaoting L, Yin T, Yangxi C. Interventions for pain during fixed orthodontic appliance therapy. A systematic review. Angle Orthod. 2010 Sep;80(5):925-32. doi: 10.2319/010410-10.1. |
| 19361739 | Background | Salmassian R, Oesterle LJ, Shellhart WC, Newman SM. Comparison of the efficacy of ibuprofen and acetaminophen in controlling pain after orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):516-21. doi: 10.1016/j.ajodo.2007.05.020. |