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Topical Management of Xerostomia With Dry Mouth Products

NCT03611283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-08-02

No results posted yet for this study

Summary

Objectives: To assess the effects of topical dry mouth products (toothpaste and mouthwash) containing olive oil, parsley oil, provitamin B5, allantoin, betaine and xylitol in Primary Sjögren's syndrome patients with xerostomia.

Subjects and Methods: A double-blinded, placebo-controlled, randomized design where participants were randomly assigned at baseline test or placebo products. Participants used the products 3 times/day/28 days. The investigators used Visual Analog Scale for xerostomia and Oral Health Impact Profile-14, baseline and after treatment, to assess the possible improvement.

Conditions

  • Xerostomia
  • Sjogren's Syndrome

Interventions

OTHER

Mouthwash treatment

60 seconds after meals (3 times/day) during 28 days

OTHER

Toothpaste treatment

3 minutes after the mouthwash (3 times/day) during 28 days

OTHER

Mouthwash placebo

60 seconds after meals (3 times/day) during 28 days

OTHER

Toothpaste placebo

3 minutes after the mouthwash (3 times/day) during 28 days

Sponsors & Collaborators

  • Rosa María López-Pintor Muñoz

    lead OTHER

Principal Investigators

  • Rosa María López-Pintor, PhD · Universidad Complutense Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
32 Years
Max Age
73 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-03
Primary Completion
2017-11-02
Completion
2017-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03611283 on ClinicalTrials.gov