Pain Associated With Fixed Orthodontic Treatment Clinical Trial
Official title:
Efficacy of Chewing Sugarless Gum for Reduction of Orthodontic Fixed Appliance Activation Pain
This study investigates whether chewing sugar-free chewing gum can reduce pain associated with braces treatment. The study collects pain scale records for 10 consecutive days after placement of braces. No changes to patients routine braces treatment is done. All materials used are available over the counter.
Objectives:
1. To characterize the intensity and dynamics of pain experienced by patients following
orthodontic appliance placement and activation using a set of Visual Analogue pain
scale diaries
2. To determine whether chewing sugarless gum 3 times per day (and using a non-analgesic
mouthwash) reduces orthodontic pain compared to only using a mouthwash (placebo)
Importance:
Pain from orthodontic treatment affects most if not all orthodontic patients. Learning more
about the nature and timing of pain will help clinicians give patients a more scientific,
evidence-based informed consent. If chewing gum was found to reduce pain, then we would have
validated a common clinical advice with scientific evidence. We will also have established a
non-pharmacological option for pain reduction with orthodontic treatment. If chewing gum was
not found to reduce pain (or was found to increase it), then we can advise our patients
against using it and advise clinicians against recommending it.
Research Methodology
Inclusion criteria:
- Comprehensive fixed upper and lower orthodontic treatment scheduled
- Age of patient between 10-35
Exclusion Criteria:
- Partial engagement of teeth
- The use of functional or extra-oral appliances
- Patients on regular pain medications
- Patient experiencing chronic pain
- Patients unable to consume sugarless gum because of health reasons e.g. phenyl ketone
urea o Patients with mental or cognitive impairments
Group Assignment:
For our sample size estimation we used a standard deviation of 20 (taking into consideration
several previous studies of other investigators), an effect size of 15, a significance level
of 0.05, and a power of 0.8. It indicates the need for 58 subjects in total. Based on this,
our goal is to include 80 subjects in anticipation of possible drop-outs. Patients will be
randomly assigned to one of two groups: a chewing gum group and a control mouthwash group.
Study kits will be numbered according to a random number table. Forty kits will contain
instructions and supplies for the chewing gum group and forty will contain instructions and
supplies for the control group. Assignment is done immediately after orthodontic appliances
are placed. Operators will be blinded to the group assignment as it is done by a separate
investigator. This investigator will administer to the patients the consent forms and give
them instructions according to their group assignment. The investigator will give the
participants a pre- randomized study kit containing a VAS booklet and either enough servings
of chewing gum and a container of mouthwash or a container of mouthwash only with
corresponding verbal and written instructions.
Materials used:
We will provide to the chewing gum group subjects with enough servings of Wrigley's extra
sugar-free chewing gum (with some extra pieces as backup). The chewing gum used is Mentos 3D
which contains both sorbitol and xylitol (non-hard coated type used). The mouth wash used
for both groups is Plax SensitiveTM fluoride containing mouthwash which is alcohol free and
causes significantly less burning sensations than regular mint mouthwashes. The mouthwash
will be supplied to the subjects in unlabeled containers so as to work as a placebo. The
subjects will not be told that this is a regular mouthwash with no pain reducing effects.
Each of the two groups' subjects are ignorant to what the other group is receiving and
whether they are in a control group or not.
The VAS pain scale:
The VAS pain scale used in the study comprises a 100mm horizontal line where one end
indicates "no pain" and the other end indicates "worst possible pain". The patients will
mark each pain scale after fitting their teeth together. During the first day, patients will
mark a scale every 3 hours until bedtime starting immediately after appliance placement. For
the following 9 days, patients will mark 2 pain scales per day, one scale when they wake up
and one at bedtime. The patient places a mark on the scale according to their judgment of
the amount of pain they experience. The response is then measured to the nearest 0.5mm and
can be used as pseudo-numerical data.
The VAS booklet:
Booklets are uniquely identified by a serial number and the patients phone number. Each
booklet will be pre-randomized and assignment to either the gum group or the control group.
The group assignment and serial number are indicated on the booklet cover. After
instructions are given, the booklet cover is removed and kept in a closed container. The
group assignment is only initially known to the investigator who administers the
instructions. The remaining pages of the booklet will only be identified by the serial
number of the participant with no mention of the group assignment. This way the group
assignment is kept secret from both the operators who place the appliances, and the
measurement investigator who will later measure the patients' responses. The booklet will
contain space for participants to indicate if they have taken any non-study related
medication (e.g. an analgesic). A copy of the booklet is included will this document.
Blinding:
The design of the study is double blinded. Operators placing the appliances do not know
which group the patient belongs to because assignment is done after appliance placement. The
investigator measuring the patient responses does not know the group assignment because it
is not indicated on the VAS booklet. The patients can be considered to be blinded because
they are not aware of what the other group is receiving or that they are using a standard
mouthwash that does not affect pain. After all measurement are done the booklet covers are
reunited with their respective booklets for statistical data analysis.
Patient Compensation:
Patients will receive an electric toothbrush as an incentive for completing the study.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care