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

NCT04836234 | Unknown

• 1 other identifier: DGD170001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthodontic Pain

Keywords

Chewing gum, Orthodontic pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Reported use of chewing gum and analgesics.

  Immediately after the separator and archwire placements until up to 6 hours

• Reported use of chewing gum and analgesics.

  from 6 hours to 24 hours after the separator and archwire placements

• Reported use of chewing gum and analgesics.

  from 24 hours to 48 hours after the separator and archwire placements

• Recorded appliances breakages.

  Immediately after the separator and archwire placements until 2 days after the separator and archwire placement

Study Arms (2)

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.

Other: Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum

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.

Interventions

Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum OTHER

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

intervention group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Postgraduate Orthodontic Clinic, Faculty of Dentistry, University Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

RECRUITING

Related 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.

  PMID: 22812440 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.

  PMID: 27476354 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.

  PMID: 8893104 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.

  PMID: 20578865 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.

  PMID: 19361739 BACKGROUND

Study Officials

• 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

• Poon Pei San

  Faculty of dentistry, University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Poon Pei San

CONTACT

0127691145; peisanpss@gmail.com

Siti Adibah Othman, Prof

CONTACT

012-2635088; sitiadibah@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: April 8, 2021
• Study Start: March 6, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)