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

April 5, 2021 updated by: University of Malaya

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
    • Wilayah Persekutuan Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50603
        • Recruiting
        • Postgraduate Orthodontic Clinic, Faculty of Dentistry, University Malaya
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum
Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum 65g 40 pieces
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment after separators and initial arch wire placement.
Time Frame: At 6 hours 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.
Time Frame: At 24 hours 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.
Time Frame: At 48 hours 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reported use of chewing gum and analgesics.
Time Frame: Immediately after the separator and archwire placements until up to 6 hours
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.
Time Frame: from 6 hours to 24 hours after the separator and archwire placements
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.
Time Frame: from 24 hours to 48 hours after the separator and archwire placements
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.
Time Frame: Immediately after the separator and archwire placements until 2 days after the separator and archwire placement
Frequency of appliances breakages
Immediately after the separator and archwire placements until 2 days after the separator and archwire placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Study Director: Siti Adibah Othman, Prof, Faculty of Dentistry, University of Malaya
  • Study Director: Zamros Yuzadi Mohd Yusof, Prof, Faculty of Dentistry, University of Malaya
  • Principal Investigator: Poon Pei San, Faculty of Dentistry, University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2019

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

April 5, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DGD170001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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