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Topical Management of Xerostomia With Dry Mouth Products

Primary Purpose

Xerostomia, Sjogren's Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mouthwash treatment
Toothpaste treatment
Mouthwash placebo
Toothpaste placebo
Sponsored by
Rosa María López-Pintor Muñoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia focused on measuring Xerostomia, Sjögren's syndrome, Topical dry mouth products, Olive Oil, Oral Health Impact Profile

Eligibility Criteria

32 Years - 73 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Test group

    Placebo group

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    July 16, 2018
    Last Updated
    August 1, 2018
    Sponsor
    Rosa María López-Pintor Muñoz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03611283
    Brief Title
    Topical Management of Xerostomia With Dry Mouth Products
    Official Title
    Topical Products to Treat Xerostomia in Primary Sjögren's Syndrome: a Double-blind Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 3, 2016 (Actual)
    Primary Completion Date
    November 2, 2017 (Actual)
    Study Completion Date
    November 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Rosa María López-Pintor Muñoz

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Xerostomia, Sjogren's Syndrome
    Keywords
    Xerostomia, Sjögren's syndrome, Topical dry mouth products, Olive Oil, Oral Health Impact Profile

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized double-blind placebo controlled study
    Masking
    ParticipantCare Provider
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Test group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Mouthwash treatment
    Intervention Description
    60 seconds after meals (3 times/day) during 28 days
    Intervention Type
    Other
    Intervention Name(s)
    Toothpaste treatment
    Intervention Description
    3 minutes after the mouthwash (3 times/day) during 28 days
    Intervention Type
    Other
    Intervention Name(s)
    Mouthwash placebo
    Intervention Description
    60 seconds after meals (3 times/day) during 28 days
    Intervention Type
    Other
    Intervention Name(s)
    Toothpaste placebo
    Intervention Description
    3 minutes after the mouthwash (3 times/day) during 28 days
    Primary Outcome Measure Information:
    Title
    Changes in Validated visual analogue scale questionnaire for xerostomia
    Description
    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.
    Time Frame
    At baseline and day 28
    Secondary Outcome Measure Information:
    Title
    Changes in Oral patient's quality of life
    Description
    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.
    Time Frame
    At baseline and day 28

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    32 Years
    Maximum Age & Unit of Time
    73 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rosa María López-Pintor, PhD
    Organizational Affiliation
    Universidad Complutense Madrid
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12006334
    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 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.
    Results Reference
    background
    PubMed Identifier
    8215087
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17824884
    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. doi: 10.1111/j.1365-2842.2006.01718.x.
    Results Reference
    background
    PubMed Identifier
    11250628
    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. doi: 10.1067/moe.2001.111551.
    Results Reference
    background
    PubMed Identifier
    19114956
    Citation
    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.
    Results Reference
    background

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    Topical Management of Xerostomia With Dry Mouth Products

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