Impact of Periodontal Treatment on Gastric Helicobacter Pylori Eradication

Periodontal Tedavinin Helikobakter Pilori Eradikasyon ve Rekürrensine Katkısının İncelenmesi

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Triple therapy; Procedure: professional periodontal treatment

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Drug: Triple therapy; triple therapy:a 10-day course of a Lansoprazole (proton pump inhibitor )combined with amoxicillin (2 × 1 g daily) and clarithromycin (2 × 500 mg daily).(trio); Other Names: Systemic eradication therapy
Experimental: Combined 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	Drug: Triple therapy; triple therapy:a 10-day course of a Lansoprazole (proton pump inhibitor )combined with amoxicillin (2 × 1 g daily) and clarithromycin (2 × 500 mg daily).(trio); Other Names: Systemic eradication therapy; Procedure: professional periodontal treatment; periodontal treatment consisting of mechanical periodontal treatment (scaling and root planing) Oral hygiene insruction Periodontal treatment started concurrently with triple therapy; Other Names: initial periodontal therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eradication rate of gastric H. pylori infection	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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oral H. pylori eradication	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.	3 months
periodontal parameters (Probing depth)	probing depth used as a surrogate marker to measure periodontal disease severity	3 months
Clinical Attachment level	used as a surrogate marker to measure severity of the periodontal disease	3 months
OHI (Oral Hygiene Index)	this index used to determine patient oral hygiene status (Greene and Vermillion, 1964)	3 months
Gingival Index	Löe-Silness gingival index	3 months
Plaque index	this index used to determine patient oral hygiene status (Silness-Löe)	3 months
Bleeding on Probing	an index give information on inflammation status of periodontal tissues	3 months

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2008
• Primary Completion (Actual): July 7, 2011
• Study Completion (Actual): February 17, 2012

Study Registration Dates

• First Submitted: June 10, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: periodontal treatment; H. pylori; Initial periodontal therapy
• Other Study ID Numbers: OndokusMU1; OMUetik 2009/95 (Other Identifier: Ondokuz Mayıs University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No