Clinical trial NCT04836234: Chewing Gum Effect in Reducing Orthodontic Pain After Separator and Initial Arch Wire Placement
Official title: The Effect of the Chewing Gum in Alleviating Orthodontic Pain After Separator and Initial Arch Wire Placement: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Pain
Keywords: Chewing gum, Orthodontic pain
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 108
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain assessment after separators and initial arch wire placement.
timeFrame: At 6 hours after separators and initial arch wire placement.
measure: Pain assessment after separators and initial arch wire placement.
timeFrame: At 24 hours after separators and initial arch wire placement.
measure: Pain assessment after separators and initial arch wire placement.
timeFrame: At 48 hours after separators and initial arch wire placement.
Secondary outcomes:
measure: Reported use of chewing gum and analgesics.
timeFrame: Immediately after the separator and archwire placements until up to 6 hours
measure: Reported use of chewing gum and analgesics.
timeFrame: from 6 hours to 24 hours after the separator and archwire placements
measure: Reported use of chewing gum and analgesics.
timeFrame: from 24 hours to 48 hours after the separator and archwire placements
measure: Recorded appliances breakages.
timeFrame: Immediately after the separator and archwire placements until 2 days after the separator and archwire placement
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Postgraduate Orthodontic Clinic, Faculty of Dentistry, University Malaya
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: Faculty of Dentistry, University of Malaya
name: Siti Adibah Othman, Prof
role: STUDY_DIRECTOR
affiliation: Faculty Of Dentistry, University of Malaya
name: Zamros Yuzadi Mohd Yusof, Prof
role: STUDY_DIRECTOR
affiliation: Faculty of dentistry, University of Malaya
name: Poon Pei San
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1043/0003-3219(1996)0662.3.CO;2.
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.
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.