Chewing gum and orthodontic pain
| ISRCTN | ISRCTN79884739 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79884739 |
| Clinical Trials Information System (CTIS) | 2008-005522-36 |
| Protocol serial number | 6631 |
| Sponsor | Royal United Hospital Bath NHS Trust (UK) |
| Funder | British Orthodontic Society (UK) |
- Submission date
- 29/04/2010
- Registration date
- 29/04/2010
- Last edited
- 02/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A J Ireland
Scientific
Scientific
University of Bristol
Division of Child Dental Health
Bristol
BS8 1TH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional and observational cohort study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Chewing gum and orthodontic pain: a randomised interventional and observational cohort study |
| Study objectives | The null hypothesis in this intention to treat study is that there is no difference between the use of ibuprofen and sugar-free chewing gum in the relief of orthodontic pain in the 3 days following the fitting and then subsequent adjustment of orthodontic fixed appliances. The secondary outcome measure is bracket or wire failure. In addition patient anxiety will be measured following brace fitting and subsequent adjustment as anxiety may affect the perception of pain. |
| Ethics approval(s) | North Somerset and South Bristol Research Ethics Committee, 26/11/2008, ref: 08/H0106/139 |
| Health condition(s) or problem(s) studied | Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Oral & Dental |
| Intervention | The control is ibuprofen and the intervention is sugar-free chewing gum. Study entry: single randomisation only |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Ibuprofen |
| Primary outcome measure(s) |
Pain |
| Key secondary outcome measure(s) |
1. Bond failures, measured following fitting and then following first adjustment |
| Completion date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 1000 |
| Key inclusion criteria | 1. Aged 12 - 16 years, either sex 2. Upper and lower fixed orthodontic appliances |
| Key exclusion criteria | Asthmatic with reaction to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) |
| Date of first enrolment | 19/10/2009 |
| Date of final enrolment | 01/04/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Bristol
Bristol
BS8 1TH
United Kingdom
BS8 1TH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2016 | Yes | No | |
| Results article | results | 01/03/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/03/2017: Publication reference added.
03/08/2016: Publication reference added.
