Orthodontic Pain
Conditions
Keywords
Chewing gum, Orthodontic pain
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.
Interventions
OTHERWrigley Extra Strawberry Flavour Sugar Free Chewing Gum
Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum 65g 40 pieces
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment after separators and initial arch wire placement. | At 6 hours after separators and initial arch wire placement. | Level of pain on the Numerical pain rating scale (NRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reported use of chewing gum and analgesics. | 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 |
| Recorded appliances breakages. | Immediately after the separator and archwire placements until 2 days after the separator and archwire placement | Frequency of appliances breakages |
Countries
Malaysia
Contacts
Primary ContactPoon Pei San
Backup ContactSiti Adibah Othman, Prof
Outcome results
None listed