Topical Management of Xerostomia With Dry Mouth Products

NCT03611283 | Completed DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Xerostomia; Sjögren's syndrome; Topical dry mouth products; Olive Oil; Oral Health Impact Profile

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in Oral patient's quality of life

  At baseline and day 28

Study Arms (2)

Test group

EXPERIMENTAL

Patients had to use: Mouthwash treatment (250 ml): Aqua, Betaine, Glycerin, PEG-40, Hydrogenated Castor Oil, Propylene Glycol, Xylitol, Aroma, Potassium Phosphate, Diazolidinyl Urea, Allantoin, Olea Europaea Fruit Oil, Sodium Methylparaben, Sodium Propylparaben, Sodium Fluoride, CI75810, Panthenol, Tocopheryl Acetate, Sucralose, Carum Petroselinum Seed Oil, Limonene. Toothpaste treatment (50 ml): Glycerin, Aqua, Hydrated Silica, Xylitol, Betine, Tetrapotassium Pyrophosphate, Olea Europaea Fruti Oil, Xanthan Gum, Titanium Dioxide, Potassium Phosphate, Aroma, Sodium Fluoride, Diazolidinyl Urea, Papain, Carum Petroselinum Seed Oil, Panthenol, Tocopheryl Acetate, Limonene

Other: Mouthwash treatment; Other: Toothpaste treatment

Placebo group

PLACEBO COMPARATOR

Patients had to use: Mouthwash placebo(250 ml): Aqua, Glycerin, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, flavoring, Potassium Phospate, Diazolidinyl Urea, Sodium Methylparaben, Sodium Propylparaben, Sodium Fluoride, CI75810, Tocopheryl Acetate, Sucralose, LImonene. Toothpaste placebo (50 ml): Aqua, Sorbitol, Hydrated Silica, Glycerin, Tetrapotassium Pyrophosphate, Xanthan Gum Titanium Dioxide, Sodium Lauryl Sulphate, Potassium Phosphate, flavoring, Sodium Fluoride, Diazolidinyl Urea, Sucralose, Limonene

Other: Mouthwash placebo; Other: Toothpaste placebo

Interventions

Mouthwash treatment OTHER

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

Test group

Toothpaste treatment OTHER

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

Test group

Mouthwash placebo OTHER

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

Placebo group

Toothpaste placebo OTHER

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

Placebo group

Eligibility Criteria

• Age: 32 Years - 73 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rosa María López-Pintor Muñoz: lead

Related Publications (5)

• 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 Sjogren's Syndrome. Classification criteria for Sjogren'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. doi: 10.1136/ard.61.6.554.

  PMID: 12006334 BACKGROUND

• Navazesh M. Methods for collecting saliva. Ann N Y Acad Sci. 1993 Sep 20;694:72-7. doi: 10.1111/j.1749-6632.1993.tb18343.x. No abstract available.

  PMID: 8215087 BACKGROUND

• 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. doi: 10.1111/j.1365-2842.2006.01718.x.

  PMID: 17824884 BACKGROUND

• 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. doi: 10.1067/moe.2001.111551.

  PMID: 11250628 BACKGROUND

• Montero-Martin J, Bravo-Perez M, Albaladejo-Martinez A, Hernandez-Martin 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.

  PMID: 19114956 BACKGROUND

MeSH Terms

Conditions

Xerostomia; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rosa María López-Pintor, PhD

  Universidad Complutense Madrid

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor; Co-director Speciality in Oral Medicine

Model Details: Randomized double-blind placebo controlled study

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 2, 2018
• Study Start: October 3, 2016
• Primary Completion: November 2, 2017
• Study Completion: November 30, 2017
• Last Updated: August 2, 2018

Record last verified: 2018-08