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Impact of Periodontal Treatment on Gastric Helicobacter Pylori Eradication

O

Ondokuz Mayıs University

Status and phase

Completed
Phase 1

Conditions

Helicobacter Pylori Infection

Treatments

Drug: Triple therapy
Procedure: professional periodontal treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03654781
OMUetik 2009/95 (Other Identifier)
OndokusMU1

Details and patient eligibility

About

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.

Enrollment

98 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

98 participants in 2 patient groups

Triple therapy
Active Comparator group
Description:
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).
Treatment:
Drug: Triple therapy
Combined treatment
Experimental group
Description:
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
Treatment:
Procedure: professional periodontal treatment
Drug: Triple therapy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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