Topical Management of Xerostomia With Dry Mouth Products
Condition: Xerostomia; Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Xerostomia; Syndrome
Study type: Interventional

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.
    

Detailed description: 
      The investigators conducted a randomized double-blind placebo controlled study among
      participants with Sjögren's syndrome who attended to the Oral Medicine Specialist Degree
      Program at the School of Dentistry at Complutense University in Madrid. The study was
      conducted in accordance to the principles of the Helsinki Declaration. This study followed
      the guidelines established by the Consort Statement.

      Participants. All participants had a full medical history about Primary Sjögren's syndrome,
      where their rheumatologist detailed how the correct diagnosis was made according to
      American-European Consensus Group 2002 criteria. Demographic and Primary Sjögren's syndrome
      characteristics were collected. Stimulated and unstimulated whole saliva were collected
      following the drainage method at baseline by a single trained clinician blinded to the
      treatment. The saliva was collected before giving study instructions between 8-10 am.
      Hyposalivation was present when unstimulated whole saliva was less than 0.1 ml/min or
      stimulated whole saliva was less than 0.7 ml/min.

      Preparations. The company Biocosmetics provided the test and placebo products. Placebo
      preparations were in identical white bottles (250mL) and white toothpastes (50mL) like study
      products. These preparations (study or placebo) did not contain irritant substances. The
      placebo included the same excipients resulting in solution similar to the experimental one in
      colour, flavour and density. All ingredients were equal in parts except the active products
      that were only present in the study products: betaine, xylitol, allantoin, Olea Europaea
      Fruit Oil (olive oil), Panthenol (provitamine B5) and Carum Petroselinum Seed oil (parsley
      oil). Test and placebo products contain sodium fluoride (mouthwash 250ppmF- and toothpaste
      995ppmF-).

      Interventions and instructions to participants. Participants were randomized to receive study
      or placebo mouthwash and toothpaste. Before starting treatment, participants were instructed
      to rinse with 7mL of mouthwash (study or placebo) for 60 seconds after meals (3 times/day).
      After rinsing the mouth, patients were instructed to brush their teeth with 0.5 g of study or
      placebo toothpaste following the Bass brushing technique for 3 minutes. We gave all the
      patients the same ultra soft dental brush (CS5460 Curaprox, Curaden AG, Kriens, Switzerland).
      The products had to be used for 28 days (4 weeks). Participants were informed that the use of
      any oral hygiene or xerostomia products apart from the intervention was prohibited. After
      giving the instructions, the investigators gave the patients the corresponding bag containing
      the study or placebo products, which was completely closed.

      Sample size. The sample size was calculated considering a previous study that applied the
      same products. It was estimated that, at least, 50% of the test group would improve; so with
      an alpha of 0.05 and a statistical power of 80%, 12 subjects would be required in each group.

      Randomisation. Participants were randomly assigned to one of treatments (study or placebo) in
      a 1:1 ratio using a computer-generated algorithm stratified by using a fixed block sized of
      4. The company performed the randomisation and prepared the products in opaque bags following
      the results of randomization. The participants received the correspondence bag following the
      sequence of study entry.

      Blinding. The study and placebo products had an identical appearance and were packaged
      identically. The sacs were numbered consecutively from 1 to 28. The company prepared and
      numbered the bag and all the participants were blinded to the treatment. Blinding was
      revealed after all participants finished the trial and all the data were collected.

      Statistical methods. All the analysis was done using SPSS version 22.0 (SPSS Inc. New York,
      NY, USA). Statistical analysis included basic descriptive statistics. Comparison of
      continuous variables between test and placebo groups was done using Mann-Whitney U-test.
      Comparison of categorical variables was done using Chi-square test or Fisher's exact test.
      Wilcoxon signed-rank test was used to determine whether the intragroup decreases in Visual
      Analogue Scale and Oral Health Impact Profile 14 were statistically significant. Differences
      were considered significant if p was less than or equal to 0.05.
    

Intervention name(s): Mouthwash treatment; Toothpaste treatment; Mouthwash placebo; Toothpaste placebo
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 60 seconds after meals (3 times/day) during 28 days; 3 minutes after the mouthwash (3 times/day) during 28 days; 60 seconds after meals (3 times/day) during 28 days; 3 minutes after the mouthwash (3 times/day) during 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double-blind placebo controlled study
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Xerostomia; Sjögren's syndrome; Topical dry mouth products; Olive Oil; Oral Health Impact Profile