Impact of Periodontal Treatment on Gastric Helicobacter Pylori Eradication

Phase 1

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Triple therapy; Procedure: professional periodontal treatment

• Registration Number: NCT03654781
• Lead Sponsor: Ondokuz Mayıs University

Brief Summary

The efficacy of conventional systemic antibiotic therapy for eradication of gastric H. pylori has been seriously challenged by antibiotic resistance. Identification of alternative therapeutic strategies might help to overcome the limitation. The investigators' aim was to examine the effect of adjunct periodontal therapy, on gastric H. pylori eradication rate.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-21
• Primary Completion: 2011-07-07
• Study Completion: 2012-02-17
• Study First Submitted: 2018-06-10
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-29
• Last Update Submitted: 2018-08-29
• Study First Posted: 2018-08-31
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• tested positive for H. pylori both in gastric biopsy specimens and dental plaque samples

Exclusion Criteria

The patients who had treatment with following medications within 6 months before the clinical protocol:

• had antibiotics
• had Proton pump inhibitor (PPI),
• had H2 blockers, and
• took bismuth derivatives
• had previous eradication therapy, or
• had previous periodontal therapy
• Edentulous patient
• Diabetic patients
• pregnant patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined treatment	Triple therapy	Periodontal treatment would be administered in addition to triple therapy consisted of a 10-day course of a Lansoprazole (proton pump inhibitor )combined with amoxicillin (2 × 1 g daily) and clarithromycin (2 × 500 mg daily). Periodontal treatment consisted of supra and sub gingival scaling and root planing, oral hygiene instruction
Triple therapy	Triple therapy	Conventional triple antibiotic treatment would be applied to all patients (consisted of a 10-day course of Lansoprazole (a proton pump inhibitor) combined with amoxicillin ( 2 × 1 g daily) and clarithromycin (2 × 500 mg daily).
Combined treatment	professional periodontal treatment	Periodontal treatment would be administered in addition to triple therapy consisted of a 10-day course of a Lansoprazole (proton pump inhibitor )combined with amoxicillin (2 × 1 g daily) and clarithromycin (2 × 500 mg daily). Periodontal treatment consisted of supra and sub gingival scaling and root planing, oral hygiene instruction

Primary Outcome Measures

Name	Time	Method
eradication rate of gastric H. pylori infection	3 months	The follow-up was done by a 14C-urea breath test at least 12 weeks after completion of treatment . A 14C urea breath test analyzer (HUBT-20; Headway, Guangdong, China) was used to diagnose H. pylori infection

Secondary Outcome Measures

Name	Time	Method
periodontal parameters (Probing depth)	3 months	probing depth used as a surrogate marker to measure periodontal disease severity
Bleeding on Probing	3 months	an index give information on inflammation status of periodontal tissues
oral H. pylori eradication	3 months	Oral H. pylori infection was tested by CLO test Plaque samples were collected from tooth surfaces with a sterile periodontal curette, then immediately inoculated onto CLO test gel.
Plaque index	3 months	this index used to determine patient oral hygiene status (Silness-Löe)
Gingival Index	3 months	Löe-Silness gingival index
Clinical Attachment level	3 months	used as a surrogate marker to measure severity of the periodontal disease
OHI (Oral Hygiene Index)	3 months	this index used to determine patient oral hygiene status (Greene and Vermillion, 1964)