E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050879 |
E.1.2 | Term | Orthodontic appliance wearer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will investigate pain relief following the fitting and first adjustment of orthodontic fixed braces. In each case the pain typically lasts for 7 days. The first adjustment usually occurs within 2-4 months of brace fitting, whereas the total length of treatment with braces is typically 18-24 months. The trial will therefore cease approximately 4 months after the last of the 1000 patients has been recruited. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |