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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00995319
Other study ID # 17436
Secondary ID
Status Completed
Phase N/A
First received October 14, 2009
Last updated March 31, 2017
Start date January 2008
Est. completion date July 2014

Study information

Verified date March 2017
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this clinical investigation is to evaluate acute and longlasting side effects in patients undergoing radiotherapy for cancer treatment in the head and neck area.


Description:

The "Dental Team" at the Department for Oral and Maxillofacial Surgery in Trondheim takes care of patients before, during and also after radiotherapy in the head and neck area. In spite of the use of advanced radiation protocols and prevention measures such as fluoridation splints the team observes significant side effects, both under radiation and also on the long term after concluding treatment. Common problems are for example dermal and mucosal damages, reduced salivation, dysphagia and lesions of the teeth. Aim of the study is the investigation and documentation of side effects and complications in relation to the oral cavity. During the acute and postradiation phase a continuous follow-up over a longer lasting period is proceeded with registration of all relevant parameters. This includes among others dental status and evaluation of quality of life.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date July 2014
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- radiation concerning the oral cavity

- follow-up at the Dental Team

Exclusion Criteria:

- refused approval

- survival prognosis under one year

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Norway Department for Oral and Maxillofacial Surgery, St.Olavs Hospital / NTNU Trondheim

Sponsors (3)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Helse Midt-Norge, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary salivary flow 3 months
Primary salivary flow 12 months
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