Impact of Periodontal Treatment on Gastric Helicobacter Pylori Eradication

Study Overview
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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.

Official Title
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Periodontal Tedavinin Helikobakter Pilori Eradikasyon ve Rekürrensine Katkısının İncelenmesi

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Triple therapy
* Procedure: professional periodontal treatment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triple therapy<br>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<br>* 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)<br>* Other names: Systemic eradication therapy;|
| Experimental: Combined treatment<br>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<br>* 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)<br>* Other names: Systemic eradication therapy;Procedure: professional periodontal treatment<br>* periodontal treatment consisting of mechanical periodontal treatment (scaling and root planing) Oral hygiene insruction Periodontal treatment started concurrently with triple therapy<br>* Other names: initial periodontal therapy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontal treatment, Initial periodontal therapy, H. pylori