Chlorhexidine oral gel vs. Nacl oral gel in eradication of oral H. pylori

Assessing the effectiveness of chlorhexidine digluconate 1% oral gel (CORSODYL) vs. NaCl 2.5% oral gel in eradication of H. pylori in oral cavity: a triple-blind randomised controlled clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191021045173N2

Enrollment

Registered

2020-05-05

Start date

2018-10-24

Completion date

Unknown

Last updated

2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori-associated non-ulcer dyspepsia. Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere

Interventions

Intervention 1: Intervention group1: on the first day of study, subjects received chlorhexidine digluconate1% oral gel, CORSODYL brand made in England, accompanied by the regimen prescribed by the phy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Matched samples regarding positive rapid urease test result, taken from mouth and stomach Written informed consent 18-70 years of age One or more symptoms of dyspepsia necessitating gastroenterologist's referral for endoscopy

Exclusion criteria

Exclusion criteria: Pregnancy or lactation Either mouth or stomach sample shows negative result in rapid urease test Mismatch of mouth and stomach samples regarding rapid urease test result Periodontal diseases, wearing dentures or dental crowns in molar teeth, and dental procedures within 6 months prior to recruitment Peptic ulceration or bleeding History of any antibiotics taken 2 weeks prior to endoscopy appointment Evidence of H. pylori diagnosis within 6 months prior to recruitment History of taking any medications inhibiting gastric acid secretion within 2 weeks prior to recruitment History of inflammatory bowel disease(IBD) or irritable bowel syndrome (IBS) History of smoking or alcohol use History of any cancer in the person or his first degree relatives

Design outcomes

Primary

Measure	Time frame
Improvement in Global Overall Symptom (GOS) scale score. Timepoint: Baseline, and 14 days after intervention. Method of measurement: Patients grade the severity of dyspepsia symptoms from 1 to 7 in Global Overall Symptom (GOS) scale.;Presence of H.pylori bacteria in oral cavity and efficacy of chlorhexidine 1% gel in their eradication. Timepoint: Baseline, and 14 days after intervention. Method of measurement: Assessment of oral samples taken from patients.	—

Measure

Time frame

Improvement in Global Overall Symptom (GOS) scale score. Timepoint: Baseline, and 14 days after intervention. Method of measurement: Patients grade the severity of dyspepsia symptoms from 1 to 7 in Global Overall Symptom (GOS) scale.;Presence of H.pylori bacteria in oral cavity and efficacy of chlorhexidine 1% gel in their eradication. Timepoint: Baseline, and 14 days after intervention. Method of measurement: Assessment of oral samples taken from patients.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehdi Rajabi

Islamic Azad University

mehdirj@aol.co.uk+98 21 2264 0056

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026