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Effect of chewing gum on orthodontic pain, painkiller uptake and appliance breakages

The effect of sugar-free chewing gum on self-reported orthodontic pain associated with stainless steel archwire placement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN26299165
Enrollment
80
Registered
2024-02-15
Start date
2023-04-10
Completion date
Unknown
Last updated
2024-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reducing orthodontic pain in patients with stainless steel archwire during orthodontic treatment Oral Health

Interventions

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 th

Sponsors

International Islamic University Malaysia
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Malaysia

Contacts

Public ContactJoo Ming Cheong
rescentre@iium.edu.my+603 6421 5002

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026