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

Orthodontic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04836234
• Other study ID #: DGD170001
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2019
• Est. completion date: August 2021

Study information

• Verified date: April 2021
• Source: University of Malaya
• Contact: Poon Pei San
• Phone: 0127691145
• Email: peisanpss[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. Patients about to undergo orthodontic treatment with maxillary and mandibular fixed appliances

2. Orthodontic treatment include the extraction of the permanent first or second premolars

3. Age 16 years and above

Exclusion Criteria:

1. Significant medical problem or cleft lip and palate.

2. Pregnant lady

3. Occurrence of using analgesics or antibiotics

4. History of asthma or unstable asthma the last year

5. Oral surgery in the previous 4 weeks

Related Conditions & MeSH terms

• Orthodontic Pain

Intervention

Other:
• Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum
Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum 65g 40 pieces

Locations

Country	Name	City	State
Malaysia	Postgraduate Orthodontic Clinic, Faculty of Dentistry, University Malaya	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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
Secondary	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
Secondary	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
Secondary	Recorded appliances breakages.	Frequency of appliances breakages	Immediately after the separator and archwire placements until 2 days after the separator and archwire placement