Contact information
Type
Scientific
Primary contact
Mrs Jackie Brown
ORCID ID
Contact details
Dental Radiology
F23 Guys Tower
Guy's Hospital
St Thomas Street
London
SE21 9RT
United Kingdom
-
jackie.brown@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013145948
Study information
Scientific title
Evaluation of cutting balloons for treatment of salivary duct strictures
Acronym
Study hypothesis
Are cutting balloons more effective than conventional angioplasty balloons for treating salivary duct strictures?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
Clinical evaluation and radiological (sialogram) follow up
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2003
Overall trial end date
01/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
All patients requiring treatment for salivary obstruction due to stenosis.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
25
Participant 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
Recruitment start date
01/06/2003
Recruitment end date
01/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guy's Hospital
London
SE21 9RT
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guy's and St. Thomas' NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Own account
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary