Evaluation of cutting balloons for treatment of salivary duct strictures
| ISRCTN | ISRCTN91891418 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91891418 |
| Protocol serial number | N0013145948 |
| Sponsor | Department of Health |
| Funders | Guy's and St. Thomas' NHS Foundation Trust (UK), Own account, NHS R&D Support Funding (UK) |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 28/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Jackie Brown
Scientific
Scientific
Dental Radiology
F23 Guys Tower
Guy's Hospital
St Thomas Street
London
SE21 9RT
United Kingdom
| jackie.brown@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Evaluation of cutting balloons for treatment of salivary duct strictures |
| Study objectives | Are cutting balloons more effective than conventional angioplasty balloons for treating salivary duct strictures? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Salivary duct stenosis |
| Intervention | A randomised controlled trial comparing the use of conventional balloons used for the treatment of salivary stenosis versus cutting balloons. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Clinical evaluation and radiological (sialogram) follow up |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 25 |
| Key inclusion criteria | All patients requiring treatment for salivary obstruction due to stenosis. |
| Key exclusion criteria | 1. Any patient suffering from an acute or chronic systemic illness that renders them unsuitable for elective outpatient dental treatment under local anaesthesia 2. Pregnant women 3. Patients exhibiting signs or symptoms of acute infection of the salivary gland under examination 4. Patients with an allergy to iodine (as in radiographic contrast agents) or local anaesthetic agents |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Guy's Hospital
London
SE21 9RT
United Kingdom
SE21 9RT
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 |
Editorial Notes
28/07/2017: No publications found in PubMed, verifying study status with principal investigator.
