Oral UlcerRASNCT04383236
Probiotic Lozenges for Treatment of Recurrent Aphthous Stomatitis
A study testing Probiotics and Oracure oral gel in people with Oral Ulcer, run by Reham Lotfy Aggour.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 45 years
- Conditions the study is for
- Oral Ulcer
- What is being tested?
- Probiotics and Oracure oral gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 21 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Evaluation of the Effect of Probiotic Lozenges in the Treatment of Recurrent Aphthous Stomatitis: a Randomized, Controlled Clinical Trial
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.
Read the 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
- Conditions
- Oral Ulcer
- Being tested
- Probiotics, Oracure oral gel
- Keywords
- Aphthous, lactobacillus, probiotics
- Medical subject headings
- Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsOther
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.
Oracure oral gelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ChocBalls | Experimental | (L. acidophilus containing lozenges, PharmaCare Europe Ltd; West Sussex, RH10 9NQ, UK) Receives: Other: Probiotics |
| Oracure oral gel (15 gm, Amun pharmaceutical company, Egypt) | Active comparator | Each 100 g contains:
Lidocaine HCI 2.0g. Cetylpyridinium chloride 0.1 g. Receives: Drug: Oracure oral gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
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
Measured: 5 days
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Dec 2016
- Primary completion20 Oct 2018
- Study completion21 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized, controlled, clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reham Lotfy Aggour
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reham Lotfy Aggour, October 6 University
- Investigators
- Reham Aggour, Dr, Principal investigator, Oral Medicine & Periodontology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383236
- Sponsor's protocol ID
- 23-2016
- Acronym
- RAS
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamal Y, Abdelwhab A, Salem ST, Fakhr M. Evaluation of the efficacy of supplementary probiotic capsules with topical clobetasol propionate 0.05% versus topical clobetasol propionate 0.05% in the treatment of oral lichen planus (a randomized clinical trial). BMC Oral Health. 2025 Mar 5;25(1):344. doi: 10.1186/s12903-024-05246-x.
PubMed 40045332Aggour 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.
PubMed 32820431
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Probiotic Lozenges in the Treatment of Recurrent Aphthous Stomatitis: a Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04383236
- Acronym / sponsor ID
- RAS / 23-2016
- Conditions
- Oral Ulcer
- Keywords
- Aphthous, lactobacillus, probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Reham Lotfy AggourUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 20 Oct 2018 (actual)
- Study completion
- 21 Apr 2019 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a randomized, controlled, clinical trial
| Arm | Type | Receives |
|---|---|---|
| ChocBalls | Experimental | Other: Probiotics(L. acidophilus containing lozenges, PharmaCare Europe Ltd; West Sussex, RH10 9NQ, UK) |
| Oracure oral gel (15 gm, Amun pharmaceutical company, Egypt) | Active comparator | Drug: Oracure oral gelEach 100 g contains: Lidocaine HCI 2.0g. Cetylpyridinium chloride 0.1 g. |
Who may qualify
- Ages
- 3 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsSixty 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. | Other | ChocBalls |
| Oracure oral gelSixty 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. | Drug | Oracure oral gel (15 gm, Amun pharmaceutical company, Egypt) |
Primary outcome
Ulcer size reduction
Time frame: 5 days
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
Time frame: 5 days
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
1 secondary outcome
Outbreak frequency/ 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 40045332Kamal Y, Abdelwhab A, Salem ST, Fakhr M. Evaluation of the efficacy of supplementary probiotic capsules with topical clobetasol propionate 0.05% versus topical clobetasol propionate 0.05% in the treatment of oral lichen planus (a randomized clinical trial). BMC Oral Health. 2025 Mar 5;25(1):344. doi: 10.1186/s12903-024-05246-x.
- Derived from this study: PubMed 32820431Aggour 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reham Aggour, Dr principal investigator
Oral Medicine & Periodontology department
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics and Oracure oral gel in people with Oral Ulcer, run by Reham Lotfy Aggour.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer size reduction (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04383236, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.