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Impact of Periodontal Treatment on Gastric Helicobacter Pylori Eradication

NCT ID: NCT03654781

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-21

Study Completion Date

2012-02-17

Brief Summary

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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

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Conditions

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Helicobacter Pylori Infection

Keywords

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periodontal treatment Initial periodontal therapy H. pylori

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants with positive for both for H. pylori in gastric biopsy specimens and dental plaque samples by histologic examination with immunostaining and the rapid urease test (RUT), on gastric biopsy specimens obtained during gastrointestinal endoscopy were divided into 2 groups. Patients were allocated to one of the eradication regimens: triple therapy only or triple therapy combined with periodontal treatment. Each participant in both group received of a 10-day course of a proton pump inhibitor (Lansoprazole ) combined with amoxicillin (2 × 1 g daily) and clarithromycin (2 × 500 mg daily). Meanwhile, combined treatment group further received periodontal treatment consisted of scaling or combined with root planing and oral hygiene instructions.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Triple therapy

Intervention Type DRUG

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)

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

Group Type EXPERIMENTAL

Triple therapy

Intervention Type DRUG

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)

professional periodontal treatment

Intervention Type PROCEDURE

periodontal treatment consisting of mechanical periodontal treatment (scaling and root planing) Oral hygiene insruction Periodontal treatment started concurrently with triple therapy

Interventions

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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)

Intervention Type DRUG

professional periodontal treatment

periodontal treatment consisting of mechanical periodontal treatment (scaling and root planing) Oral hygiene insruction Periodontal treatment started concurrently with triple therapy

Intervention Type PROCEDURE

Other Intervention Names

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Systemic eradication therapy initial periodontal therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

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Ayla Öztürk

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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OMUetik 2009/95

Identifier Type: OTHER

Identifier Source: secondary_id

OndokusMU1

Identifier Type: -

Identifier Source: org_study_id