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Probiotic Lozenges for Treatment of Recurrent Aphthous Stomatitis (RAS)

Primary Purpose

Oral Ulcer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Probiotics
Oracure oral gel
Sponsored by
Reham Lotfy Aggour
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Ulcer focused on measuring Aphthous, lactobacillus, probiotics

Eligibility Criteria

3 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females aged 18-45 years old, 2. Patients presenting with RAS with the following characteristics: a. Minor aphthous ulcers less than 48 hours' duration prior to enrolment, b. Size no greater than 10 mm in diameter, c. A history that ulcers normally more than 5 days to resolve without treatment. The inclusion criteria for group B is the same except age, children with RAS aged between 3 and 12 years were recruited for the study.

Exclusion Criteria:

  • A known history of hypersensitivities, immunologic or systemic diseases, pregnancy, smoking,
  • treatment with systemic steroid or other immunomodulatory agents within 1 month before the study
  • use of nonsteroidal anti-inflammatory drugs or oral antihistamines within 1 month prior to the study
  • treatment of the ulcer with any preparation or medication within 72 hours prior to the study
  • treatment with systemic antibiotics within 2 weeks prior to the study and a history of adverse reactions to lactose or fermented milk products.
  • Children with a positive family history of RAS were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ChocBalls

    Oracure oral gel (15 gm, Amun pharmaceutical company, Egypt)

    Arm Description

    (L. acidophilus containing lozenges, PharmaCare Europe Ltd; West Sussex, RH10 9NQ, UK)

    Each 100 g contains: Lidocaine HCI 2.0g. Cetylpyridinium chloride 0.1 g.

    Outcomes

    Primary Outcome Measures

    Ulcer size reduction
    The index ulcer's size was measured on treatment days 0, 3 and 5. The investigators measured the maximum and minimum diameters when the ulcer has an oval shape, using a calibrated dental probe with millimeter markings. The two measurements were then be multiplied to represent the cross-sectional areas of the ulcer.
    Ulcer pain moderation
    a visual analog scale (VAS) consisting of a 10-cm horizontal line between poles connoting no pain (origin) to unbearable pain was used. Subjects was told to mark the line with a vertical line at the point that best represented the present pain level of the ulcer

    Secondary Outcome Measures

    Outbreak frequency/ 6 months
    Participants were asked to estimate the average duration of episodes during the past 6 months and the potential to reduce the outbreak frequency of RAS within the next 6 months was investigated

    Full Information

    First Posted
    May 7, 2020
    Last Updated
    May 7, 2020
    Sponsor
    Reham Lotfy Aggour
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04383236
    Brief Title
    Probiotic Lozenges for Treatment of Recurrent Aphthous Stomatitis
    Acronym
    RAS
    Official Title
    Evaluation of the Effect of Probiotic Lozenges in the Treatment of Recurrent Aphthous Stomatitis: a Randomized, Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2016 (Actual)
    Primary Completion Date
    October 20, 2018 (Actual)
    Study Completion Date
    April 21, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Reham Lotfy Aggour

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The application of host-modulating bacteria for therapeutic purposes is one of the strongest emerging fields. Probiotics are live microorganisms, which, when administered in an adequate amount, confer a health benefit on the host The study aimed to explore the effectiveness of probiotics in the treatment of the common ulcerative condition; minor recurrent aphthous stomatitis (RAS). We included sixty adult (group A) and 60 children patients (group B) with diagnosis of minor RAS . Both groups were divided into two subgroups, AI and BI (test subgroups ) and AII and BII (control subgroups). For test subgroups, probiotic lozenges were consecutively administered twice daily, for five days. The size and pain level of ulcers were recorded on treatment days 0, 3 and 5. The outbreak frequency of RAS within 6 months was investigated for all subgroups.
    Detailed Description
    The study aimed to explore the effectiveness of probiotics in the treatment of minor recurrent aphthous stomatitis (RAS). We performed a randomized, controlled clinical study. Sixty adult (group A) and 60 children patients (group B) with diagnosis of minor RAS were included. Both groups were divided into two subgroups, AI and BI (test subgroups) and AII and BII (control subgroups). For test subgroups, probiotic lozenges were consecutively administered twice daily, for five days. The size and pain level of ulcers were recorded on treatment days 0, 3 and 5. The outbreak frequency of RAS within 6 months was investigated for all subgroups. Compared to baseline, an improvement was evident for all subgroups. However, for effectiveness in pain reduction, a statistically significant difference in favor of AI was observed for all evaluation periods when compared to control subgroup. Regarding effectiveness in ulcer size reduction, a statistically significant difference in favor of BI was observed at day 5 when compared to control subgroup. No significant difference was observed in the effectiveness index between subgroups AI and BI (test subgroups) except in effectiveness in pain reduction at day 3. The outbreak frequency decreased significantly in subgroup BI. We concluded that topical application of probiotics decreased pain intensity and accelerate RAS healing. The effectiveness in pain reduction is more evident in adult patients while acceleration of healing is more evident in children. Probiotics could be a well-tolerated, topical therapeutic agent in the treatment of minor RAS

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Ulcer
    Keywords
    Aphthous, lactobacillus, probiotics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study is a randomized, controlled, clinical trial
    Masking
    Outcomes Assessor
    Masking Description
    All clinical outcome variables are recorded by a single investigator whom is blinded to the treatment modalities
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ChocBalls
    Arm Type
    Experimental
    Arm Description
    (L. acidophilus containing lozenges, PharmaCare Europe Ltd; West Sussex, RH10 9NQ, UK)
    Arm Title
    Oracure oral gel (15 gm, Amun pharmaceutical company, Egypt)
    Arm Type
    Active Comparator
    Arm Description
    Each 100 g contains: Lidocaine HCI 2.0g. Cetylpyridinium chloride 0.1 g.
    Intervention Type
    Other
    Intervention Name(s)
    Probiotics
    Intervention Description
    Sixty adult (group A) and 60 children patients (group B) with diagnosis of minor RAS were included. Both groups were divided into two subgroups, AI and BI (test subgroups) and AII and BII (control subgroups). For test subgroups, probiotic lozenges were consecutively administered twice daily, for five days. The size and pain level of ulcers were recorded on treatment days 0, 3 and 5. The outbreak frequency of RAS within 6 months was investigated for all subgroups.
    Intervention Type
    Drug
    Intervention Name(s)
    Oracure oral gel
    Intervention Description
    Sixty adult (group A) and 60 children patients (group B) with diagnosis of minor RAS were included. Both groups were divided into two subgroups, AI and BI (test subgroups) and AII and BII (control subgroups). For control subgroups, oracure gel were consecutively applied twice daily, for five days. The size and pain level of ulcers were recorded on treatment days 0, 3 and 5. The outbreak frequency of RAS within 6 months was investigated for all subgroups.
    Primary Outcome Measure Information:
    Title
    Ulcer size reduction
    Description
    The index ulcer's size was measured on treatment days 0, 3 and 5. The investigators measured the maximum and minimum diameters when the ulcer has an oval shape, using a calibrated dental probe with millimeter markings. The two measurements were then be multiplied to represent the cross-sectional areas of the ulcer.
    Time Frame
    5 days
    Title
    Ulcer pain moderation
    Description
    a visual analog scale (VAS) consisting of a 10-cm horizontal line between poles connoting no pain (origin) to unbearable pain was used. Subjects was told to mark the line with a vertical line at the point that best represented the present pain level of the ulcer
    Time Frame
    5 days
    Secondary Outcome Measure Information:
    Title
    Outbreak frequency/ 6 months
    Description
    Participants were asked to estimate the average duration of episodes during the past 6 months and the potential to reduce the outbreak frequency of RAS within the next 6 months was investigated
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males and females aged 18-45 years old, 2. Patients presenting with RAS with the following characteristics: a. Minor aphthous ulcers less than 48 hours' duration prior to enrolment, b. Size no greater than 10 mm in diameter, c. A history that ulcers normally more than 5 days to resolve without treatment. The inclusion criteria for group B is the same except age, children with RAS aged between 3 and 12 years were recruited for the study. Exclusion Criteria: A known history of hypersensitivities, immunologic or systemic diseases, pregnancy, smoking, treatment with systemic steroid or other immunomodulatory agents within 1 month before the study use of nonsteroidal anti-inflammatory drugs or oral antihistamines within 1 month prior to the study treatment of the ulcer with any preparation or medication within 72 hours prior to the study treatment with systemic antibiotics within 2 weeks prior to the study and a history of adverse reactions to lactose or fermented milk products. Children with a positive family history of RAS were excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Reham Aggour, Dr
    Organizational Affiliation
    Oral Medicine & Periodontology department
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32820431
    Citation
    Aggour RL, Mahmoud SH, Abdelwhab A. Evaluation of the effect of probiotic lozenges in the treatment of recurrent aphthous stomatitis: a randomized, controlled clinical trial. Clin Oral Investig. 2021 Apr;25(4):2151-2158. doi: 10.1007/s00784-020-03527-7. Epub 2020 Aug 20.
    Results Reference
    derived

    Learn more about this trial

    Probiotic Lozenges for Treatment of Recurrent Aphthous Stomatitis

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