One of the most frequent side effects of orthodontic treatment with fixed braces is pain. This usually begins 2 to 3 hours after the fitting or adjustment of orthodontic appliances and may last up to 7 days. To date, pain relief is customarily achieved through the use of analgesics such as Ibuprofen. There is some indication, largely through anecdotal evidence, that chewing gum may provide some pain relief and eliminate or reduce the need for analgesia. MedDRA version: 9.1 Level: LLT Classifica
Conditions
Interventions
Trade Name: Ibuprofen
Product Name: Ibuprofen
Pharmaceutical Form: Tablet
INN or Proposed INN: IBUPROFEN
CAS Number: 15687271
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
RUH (Bath) NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Fit and healthy children aged between 12-16 years of age who are undergoing routine treatment with upper and lower orthodontic fixed braces Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients for whom informed consent cannot be obtained Patients with a history of bronchial asthma, chronic inflammatory intestinal disease, renal impairment, hepatic dysfunction, patients receiving concomitant medications such as corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the use of sugar free chewing gum is as effective, or indeed more effective, in the relief of orthodontic pain than the use of Ibuprofen following the fitting and subsequent adjustment of orthodontic fixed braces.;Secondary Objective: To determine whether the pain experienced following the fitting and adjustment of orthodontic fixed braces is affected by the level of anxiety experienced by the patient and to determine whehter the use of sugar free chewing gum reuslts in more brace breakages during treatment.;Primary end point(s): Patients will take part in the trial at two descrete time periods. The first will be for 7 days following the fitting of their orthodontic braces and then for 7 days following the fitting of the next set of new wires to the brace. This is because the pain experienced with orthodontic fixed braces last up to a maximum of 7 days following the fitting of the brace and each subsequent wire adjustment. It is therefore anticipated each patient will have completed the trial within 4 months of the fitting of their fixed orthodontic braces. | — |
Countries
United Kingdom
Outcome results
None listed