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

Phase 2

Conditions: Helicobacter pylori-associated non-ulcer dyspepsia.
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere
B96.81

Registration Number: IRCT20191021045173N2

Lead Sponsor: Islamic Azad University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 70

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures