Probiotic Lozenges for Treatment of Recurrent Aphthous Stomatitis

NCT04383236 | Completed

• 1 other identifier: 23-2016
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oral Ulcer

Keywords

Aphthous, lactobacillus, probiotics

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  5 days

Secondary Outcomes (1)

• Outbreak frequency/ 6 months

  6 months

Study Arms (2)

ChocBalls

EXPERIMENTAL

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

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.

Drug: Oracure oral gel

Interventions

Probiotics OTHER

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.

ChocBalls

Oracure oral gel DRUG

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.

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

Eligibility Criteria

• Age: 3 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reham Lotfy Aggour: lead

Related Publications (2)

• 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.

  PMID: 40045332 DERIVED

• 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.

  PMID: 32820431 DERIVED

MeSH Terms

Conditions

Oral Ulcer

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Reham Aggour, Dr

  Oral Medicine & Periodontology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All clinical outcome variables are recorded by a single investigator whom is blinded to the treatment modalities
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor of Oral Medicine, diagnosis & Periodontology

Model Details: The study is a randomized, controlled, clinical trial

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: December 1, 2016
• Primary Completion: October 20, 2018
• Study Completion: April 21, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share