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

NCT ID: NCT04836234

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2021-08-31

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.

Conditions

Orthodontic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

intervention group

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.

Group Type: EXPERIMENTAL

Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum

Intervention Type: OTHER

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

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siti Adibah Othman, Prof

Role: STUDY_DIRECTOR

Faculty of Dentistry, University of Malaya

Zamros Yuzadi Mohd Yusof, Prof

Role: STUDY_DIRECTOR

Faculty Of Dentistry, University of Malaya

Poon Pei San

Role: PRINCIPAL_INVESTIGATOR

Faculty of dentistry, University of Malaya

Locations

Postgraduate Orthodontic Clinic, Faculty of Dentistry, University Malaya

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Poon Pei San

Role: CONTACT

peisanpss@gmail.com

0127691145

Siti Adibah Othman, Prof

Role: CONTACT

sitiadibah@um.edu.my

012-2635088

Facility Contacts

Pei San Poon

Role: primary

peisanpss@gmail.com

0127691145

References

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.

Reference Type: BACKGROUND

PMID: 22812440 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27476354 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8893104 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20578865 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19361739 (View on PubMed)

Other Identifiers

DGD170001

Identifier Type: -

Identifier Source: org_study_id