Trials Sponsors Conditions Drugs Pricing

Conditions

Radiation-Induced Xerostomia

Keywords

XerostomiaRadiotherapy of head and neckBioXtra

Outcome Measures

Primary Outcomes (1)

improvement of xerostomia
change of symptoms of xerostomia is measured by Visual Analogue Scale and Dichotomos questionnaire\[ Time Frame: baseline compared with measures on day 14
2 weeks

Secondary Outcomes (1)

comparative analysis of improvement xerostomia between 2 drugs
5 weeks

Study Arms (1)

bioxtra spray and mouth rinse

OTHER

Drug: BioXtra spray or mouth rinse Patients had been xerostomia due to radiation of head and neck were selected for the study. Gender, age, medical history, VAS, dichotomous questionnaire of xerostomia , and other treatment used for this disease were recorded. Local ethical committee approval was obtained before the trial started and all patients gave written informed consent. Patients were randomly divided into two groups .First group received BioXtra spray and second group used BioXtra mouth rinse for 2 weeks and then 1 weeks wash -out period and for other 2 weeks drugs is switched . Each patients was examined at the beginning of the therapy ,and then 2 weeks after therapy and 35 days after first visit.

Drug: bioxtra

Interventions

bioxtraDrug

spray /mouth rinse

Also known as: saliva subsitute

bioxtra spray and mouth rinse

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

complaint of xerostomia after head and neck radiotherapy
patient must have given written informed consent

You may not qualify if:

Sponsors & Collaborators

Imam Khomeini Hospital
Othercollaborator
Qazvin University Of Medical Sciences
Otherlead

Study Sites (1)

Qazvin University of Medical Sciences

Qazvin, Qazvin Province, 3415759811, Iran

MeSH Terms

Conditions

Xerostomia

Interventions

BioXtra

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

Mahin Bakhshi, DDS/MS
Qazvin University Of Medical Sciences
STUDY CHAIR
Touba Karagah, DDS
QUMS
PRINCIPAL INVESTIGATOR
Soheila Manifar, DDS/MS
Imam Khomeini Hospital
STUDY DIRECTOR
Navid Mohamadi, PHD
QUMS
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: SUPPORTIVE CARE
Intervention Model: CROSSOVER
Sponsor Type: OTHER

Study Record Dates

First Submitted

August 27, 2010

First Posted

September 6, 2010

Study Start

July 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2010

Actual (reported)

Comparative Analysis of BioXtra on Xerostomia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

bioxtra spray and mouth rinse

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

bioxtra spray and mouth rinse

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations