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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03578900
Other study ID # QL2015
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2013
Est. completion date December 31, 2016

Study information

Verified date July 2018
Source Grupo de Investigação em Bioquímica e Biologia Oral
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aims of this study are: To compare salivary pH changes and stimulation efficacy of two different Gustatory Stimulants of Salivation (GSSS) in patients with Primary Sjögren Syndrome (PSS); To evaluate Primary Sjögren syndrome (PSS) impact and gustatory stimulants of salivary secretion (GSSS) on oral health related quality of life measured by a Portuguese version of Oral Health Impact Profile-14 (OHIP-14) and specific Xerostomia assessment questionnaires.

The Products to be used are the Xeros® Dentaid system and a citric based mouthwash.


Recruitment information / eligibility

Status Completed
Enrollment 289
Est. completion date December 31, 2016
Est. primary completion date December 31, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- unstimulated whole saliva secretion rate < 0.1 ml/min

- stimulated whole saliva secretion rate > 0.2 ml/min

- above 18 years of age

- Primary Sjogren Syndrome diagnostic according to the European-American Consensus Group

Exclusion Criteria:

- wearer of complete dental prosthesis

- those who were pregnant or lactating

- non-speakers of Portuguese.

Study Design


Intervention

Drug:
Xeros

Citric Acid based Mouthwash


Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Grupo de Investigação em Bioquímica e Biologia Oral Dentaid, Portuguese Institute of Rheumatology, University of Lisbon

Outcome

Type Measure Description Time frame Safety issue
Primary Time of GSSS induced pH drop below 4.5 On the day that the system is attributed the subject is asked to use one of the products and saliva is collected. pH variation is determined at fixed intervals during 20 minutes. Time in which salivary pH is below 4.5 is calculated as well as the number needed to treat and the absolute risk reduction. 20 minutes
Primary Overall and sub domains scores for each questionnaire Before and after usage of both products at home, the Summated Xerostomia Inventory-5 (range 0 to 15) to measure subjective feeling of dry mouth, Oral Health Impact Profile-14 (range 0 to 56) to measure quality of life perception related to the oral cavity. This last questionnaire is further divided into 7 subdomains: functional limitation, physical pain, psychological discomfort, physical disability, psychologic disability, social disability and handicap each ranging from 0 to 14.
In both questionnaires the total score is the result of the sum of the individual scores in each question.
In both questionnaires the higher the score the worse the outcome. The before and after scores obtained are then compared.
15 days
Secondary Salivary stimulant induced salivary flow While using one of the two products saliva is collected, weighed and salivary flow is determined at fixed times during 20 minutes. 20 minutes
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