Condition category
Digestive System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
28/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes