Impact of Periodontal Treatment on Gastric Helicobacter Pylori Eradication

NCT03654781 | Completed Phase 1

• 2 other identifiers: OndokusMU1OMUetik 2009/95
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Helicobacter Pylori Infection

Keywords

periodontal treatment; Initial periodontal therapy; H. pylori

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• oral H. pylori eradication

  3 months

• periodontal parameters (Probing depth)

  3 months

• Clinical Attachment level

  3 months

• OHI (Oral Hygiene Index)

  3 months

• Gingival Index

  3 months

Study Arms (2)

Triple therapy

ACTIVE COMPARATOR

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

Combined treatment

EXPERIMENTAL

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; Procedure: professional periodontal treatment

Interventions

Triple therapy 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)

Also known as: Systemic eradication therapy

Combined treatment; Triple therapy

professional periodontal treatment PROCEDURE

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

Also known as: initial periodontal therapy

Combined treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2018
• First Posted: August 31, 2018
• Study Start: April 21, 2008
• Primary Completion: July 7, 2011
• Study Completion: February 17, 2012
• Last Updated: August 31, 2018

Record last verified: 2018-08