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Probiotic Lozenges for Treatment of Recurrent Aphthous Stomatitis

NCT04383236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-05-12

No results posted yet for this study

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

Interventions

OTHER

Probiotics

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.

DRUG

Oracure oral gel

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.

Sponsors & Collaborators

  • Reham Lotfy Aggour

    lead OTHER

Principal Investigators

  • Reham Aggour, Dr · Oral Medicine & Periodontology department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-01
Primary Completion
2018-10-20
Completion
2019-04-21

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04383236 on ClinicalTrials.gov