Effect of chewing gum on orthodontic pain, painkiller uptake and appliance breakages
| ISRCTN | ISRCTN26299165 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26299165 |
- Submission date
- 14/02/2024
- Registration date
- 15/02/2024
- Last edited
- 15/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Orthodontic fixed appliances are related to the experience of mild-to-severe pain and discomfort in patients undergoing treatment. Due to the unpleasant experience, there was an apparent poor compliance issue, with many discontinued orthodontic treatments. Various interventions are utilized to overcome pain during orthodontic treatments including the use of pain medications. However, concerns have been raised with regards to their long-term treatment side effects. Sugar-free chewing gum is one of the growing alternatives in the management of pain in orthodontic treatments. Current literature on the effectiveness of pain control by chewing gum is only limited to initial phase of orthodontic treatment and no study has been further conducted on a later stage of orthodontic treatment, such as using final stainless steel working archwire. Therefore, this randomised controlled trial aims to study the effects of chewing sugar-free gum on self-reported pain, use of analgesic medications and appliance breakages associated with the use of stainless steel working archwires.
Who can participate?
Healthy female patients aged 20-40 years old who are currently undergoing upper and lower fixed orthodontic treatment having upper and lower stainless steel archwires with no pain-related disease can participate.
What does the study involve?
Subjects are randomly allocated into two groups of 22 subjects each; chewing gum group (experimental group) and the control group. Subjects in the chewing gum group are instructed to chew gum for 5 minutes immediately after archwire placement. Subjects in both groups record their pain using Visual Analogue Scale (VAS) instrument at baseline before archwire placement, immediately after, and at 12, 24, 36, 48, 60 and 72 hours.
What are the possible benefits and risks of participating?
No specific risks involved. Chewing gum may serve as an adjunct for orthodontists for better pain management in their patients having stainless steel archwire.
Where is the study run from?
Klinik Pergigian Dr Fatain Indera Mahkota 3 & Department of Orthodontics, Kulliyyah of Dentistry (Kuantan, Malaysia)
When is the study starting and how long is it expected to run for?
October 2022 to December 2023
Who is funding the study?
International Islamic University Malaysia (IIUM)
Who is the main contact?
Cheong Joo Ming; alvinjooming@iium.edu.my
Contact information
Public, Scientific, Principal Investigator
Kulliyyah of Dentistry, International Islamic University Malaysia
Jalan Istana, Bandar Indera Mahkota, Pahang
Kuantan
25200
Malaysia
 ORCID ID |
0000-0002-7487-7396 |
|---|---|
| Phone | +603 6421 5002 |
| rescentre@iium.edu.my |
Study information
| Study design | Multicenter interventional simple randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic |
| Study type | Treatment |
| Participant information sheet | 45046 PIS v1 09Feb2023.pdf |
| Scientific title | The effect of sugar-free chewing gum on self-reported orthodontic pain associated with stainless steel archwire placement |
| Study objectives | 1. Sugar-free gum is associated with pain-relief effects in patients with stainless steel working archwires. 2. Sugar-free gum reduces the intake of analgesic medications in patients with stainless steel wire. 3. Chewing gum group is associated with increased frequency of appliance breakages compared to non-chewing gum group. |
| Ethics approval(s) |
Approved 14/02/2023, International Islamic University Malaysia Research Ethics Committee (IREC) (Kulliyyah of Dentistry, International Islamic University Malaysia, Jalan Istana, Bandar Indera Mahkota, Pahang, Kuantan, 25200, Malaysia; +60 168577697; alvinjooming@iium.edu.my), ref: IREC 2023-032 |
| Health condition(s) or problem(s) studied | Reducing orthodontic pain in patients with stainless steel archwire during orthodontic treatment |
| Intervention | Female participants are randomly allocated into either chewing gum group or control group using random table generation (WebPower Statistical power analysis online) and sealed envelope. Subjects in the chewing gum group are instructed to chew sugar-free gum (Wrigley's Extra, Malaysia) for 5 minutes followed by marking the pain level on the visual analogue scale (VAS) to assess pain at baseline (before placement of stainless steel archwires), immediately after placement (0 hour), at 12, 24, 36, 48, 60 and 72 hours after archwire placement. No chewing gum will be given to the control group. |
| Intervention type | Other |
| Primary outcome measure | Self-reported orthodontic pain using a visual analogue scale (VAS) at baseline (before placement of stainless steel archwires), immediately after placement (0 hour), at 12, 24, 36, 48, 60 and 72 hours after archwire placement. |
| Secondary outcome measures | 1. Analgesic uptake measured using self-reported questionnaire (frequency, type, dosage and timing of analgesics taken) during the 72-hour study period. 2. Appliances breakages (brackets/tubes/bands) measured using self-reported questionnaire during the 72-hour study period. |
| Overall study start date | 20/10/2022 |
| Completion date | 02/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target number of participants | 80 |
| Total final enrolment | 44 |
| Key inclusion criteria | 1. Healthy female aged 20-40 years old 2. Patients fitted with both upper and lower 0.019” x 0.025” rectangular stainless steel archwires on upper and lower pre-adjusted edgewise fixed orthodontic appliances treatment 3. Non-smoker 4. Patients with no craniofacial anomalies 5. No pain-related pathology or disease 6. Not receiving any form of analgesics 7. No oral surgery in the previous 4 weeks |
| Key exclusion criteria | 1. Subjects who only had upper or lower stainless steel archwires 2. Subjects who receive any form of analgesics 3. Subjects who had oral surgery in the previous four weeks 4. Pregnant woman 5. Subjects who have previous orthodontic/orthognathic treatment 6. Subjects who have hypersensitivity reactions to aspirin or other NSAIDs including asthma, rhinitis or urticaria |
| Date of first enrolment | 10/04/2023 |
| Date of final enrolment | 28/11/2023 |
Locations
Countries of recruitment
- Malaysia
Study participating centres
Kuantan
25200
Malaysia
Kuantan
25200
Malaysia
Sponsor information
University/education
Kulliyyah of Dentistry, International Islamic University Malaysia
Jalan Istana, Bandar Indera Mahkota, Pahang
Kuantan
25200
Malaysia
| Phone | +603 6421 6421 |
|---|---|
| webmaster@iium.edu.my | |
| Website | https://office.iium.edu.my/ocd/ |
"ROR" |
https://ror.org/03s9hs139 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Universiti Islam Antarabangsa Malaysia, IIUM
- Location
- Malaysia
Results and Publications
| Intention to publish date | 30/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (https://docs.google.com/document/d/1OAd-fjR0TI87DDauzcp3EQzeMvJsui8cNI8G86On52s/edit#heading=h.a1103o6boelk) All the data analysis pertaining to descriptive and inferential (One-way Repeated Measure ANOVA & Chi-square) statistics are already made available in the provided link. Consent from all participants have been obtained for data that will be used for publication purposes. All data have been made anonymized. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 09/02/2023 | 15/02/2024 | No | Yes |
| Protocol file | version 1 | 09/02/2023 | 15/02/2024 | No | No |
Additional files
Editorial Notes
15/02/2024: Trial's existence confirmed by International Islamic University Malaysia Research Ethics Committee (IREC).
