CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Mouthwash treatment +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03611283
NCT03611283N/ACompleted

Topical Products to Treat Xerostomia in Primary Sjögren's Syndrome: a Double-blind Clinical Trial

Rosa María López-Pintor Muñoz·interventional·Posted Aug 2, 2018·Updated Aug 2, 2018

In Brief

A clinical study evaluating Mouthwash treatment, Toothpaste treatment, and 2 other interventions for Xerostomia and Sjogren's Syndrome. Completed, enrolled 28 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2, 2018
Enrollment StartOct 3, 2016
Primary CompletionNov 2, 2017
Study CompletionNov 30, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.9 years ago

Interventions

Mouthwash treatmentother

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

Toothpaste treatmentother

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

Mouthwash placeboother

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

Toothpaste placeboother

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