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Completed

NCT Number: NCT03578900

Quality of Life and Sjögren Syndrome

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.

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Key information

Conditions

Xerostomia Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Hyposalivation Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Quality of Life Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xeros

Drug

Citric Acid based Mouthwash

Drug

Primary outcomes

  1. Time of GSSS induced pH drop below 4.5

    Time frame: 20 minutes

    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.

  2. Overall and sub domains scores for each questionnaire

    Time frame: 15 days

    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.

Secondary outcomes

  1. Salivary stimulant induced salivary flow

    Time frame: 20 minutes

    While using one of the two products saliva is collected, weighed and salivary flow is determined at fixed times during 20 minutes.

Sponsors and collaborators

Lead sponsor

Grupo de Investigação em Bioquímica e Biologia Oral

Other

Collaborators

  • Dentaid SL
  • Portuguese Institute of Rheumatology
  • University of Lisbon

Registry information

Official study title

Quality of Life in a Portuguese Population With Primary Sjögren Syndrome

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Jul 6, 2018
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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