Topical Management of Xerostomia With Dry Mouth Products

Sjogren's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611283
• Other study ID #: 0001
• Status: Completed
• Phase: N/A
• Start date: October 3, 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: August 2018
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 30, 2017
• Est. primary completion date: November 2, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 32 Years to 73 Years

Eligibility

Inclusion Criteria:

• 18 years of age or older, pSS patients diagnosed according to the AECG-2002 criteria, patients suffering xerostomia sensation, willingness to participate in the study, mentally and physical ability to participate and complete the study

Exclusion Criteria:

• patients who received or are being treated with head and neck radiotherapy, chemotherapy, pregnant and breast-feeding women and patients who were using other topical or systemic treatments for xerostomia.

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome
• Xerostomia

Intervention

Other:
• Mouthwash treatment
60 seconds after meals (3 times/day) during 28 days
• Toothpaste treatment
3 minutes after the mouthwash (3 times/day) during 28 days
• Mouthwash placebo
60 seconds after meals (3 times/day) during 28 days
• Toothpaste placebo
3 minutes after the mouthwash (3 times/day) during 28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rosa María López-Pintor Muñoz

References & Publications (5)

Montero-Martín J, Bravo-Pérez M, Albaladejo-Martínez A, Hernández-Martín LA, Rosel-Gallardo EM. Validation the Oral Health Impact Profile (OHIP-14sp) for adults in Spain. Med Oral Patol Oral Cir Bucal. 2009 Jan 1;14(1):E44-50. — View Citation

Navazesh M. Methods for collecting saliva. Ann N Y Acad Sci. 1993 Sep 20;694:72-7. Review. — View Citation

Pai S, Ghezzi EM, Ship JA. Development of a Visual Analogue Scale questionnaire for subjective assessment of salivary dysfunction. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Mar;91(3):311-6. — View Citation

Ship JA, McCutcheon JA, Spivakovsky S, Kerr AR. Safety and effectiveness of topical dry mouth products containing olive oil, betaine, and xylitol in reducing xerostomia for polypharmacy-induced dry mouth. J Oral Rehabil. 2007 Oct;34(10):724-32. — View Citation

Vitali C, Bombardieri S, Jonsson R, Moutsopoulos HM, Alexander EL, Carsons SE, Daniels TE, Fox PC, Fox RI, Kassan SS, Pillemer SR, Talal N, Weisman MH; European Study Group on Classification Criteria for Sjögren's Syndrome. Classification criteria for Sjögren's syndrome: a revised version of the European criteria proposed by the American-European Consensus Group. Ann Rheum Dis. 2002 Jun;61(6):554-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Validated visual analogue scale questionnaire for xerostomia	The questionnaire contained 8 items. Subjects marked a vertical line through a 10cm horizontal line to indicate their level of dryness in each question. The total score range from 0 to 80 cm.	At baseline and day 28
Secondary	Changes in Oral patient's quality of life	The Spanish validated version of the Oral Health Impact Profile-14 questionnaire that included 14 questions about oral pain, physical, psychological, and social limitations and disabilities whose score range from 0 to 4 was used. The total score varies from 0 to 56. Poorer scores correspond to higher quality of life.	At baseline and day 28