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