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Trial record 37 of 49 for:    Sodium Lauryl Sulfate

Topical Management of Xerostomia With Dry Mouth Products

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ClinicalTrials.gov Identifier: NCT03611283
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Rosa María López-Pintor Muñoz, Universidad Complutense de Madrid

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.


Condition or disease Intervention/treatment Phase
Xerostomia Sjogren's Syndrome Other: Mouthwash treatment Other: Toothpaste treatment Other: Mouthwash placebo Other: Toothpaste placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized double-blind placebo controlled study
Masking: Double (Participant, Care 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.
Primary Purpose: Treatment
Official Title: Topical Products to Treat Xerostomia in Primary Sjögren's Syndrome: a Double-blind Clinical Trial
Actual Study Start Date : October 3, 2016
Actual Primary Completion Date : November 2, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test group

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

Other: Toothpaste treatment
3 minutes after the mouthwash (3 times/day) during 28 days

Placebo Comparator: Placebo group

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

Other: Toothpaste placebo
3 minutes after the mouthwash (3 times/day) during 28 days




Primary Outcome Measures :
  1. Changes in Validated visual analogue scale questionnaire for xerostomia [ Time Frame: At baseline and day 28 ]
    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 :
  1. Changes in Oral patient's quality of life [ Time Frame: At baseline and day 28 ]
    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.



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Ages Eligible for Study:   32 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611283


Sponsors and Collaborators
Rosa María López-Pintor Muñoz
Investigators
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Study Director: Rosa María López-Pintor, PhD Universidad Complutense Madrid

Publications:
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Responsible Party: Rosa María López-Pintor Muñoz, Associate Professor; Co-director Speciality in Oral Medicine, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT03611283     History of Changes
Other Study ID Numbers: 0001
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rosa María López-Pintor Muñoz, Universidad Complutense de Madrid:
Xerostomia
Sjögren's syndrome
Topical dry mouth products
Olive Oil
Oral Health Impact Profile
Additional relevant MeSH terms:
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Sjogren's Syndrome
Xerostomia
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases