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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03654781
Other study ID # OndokusMU1
Secondary ID OMUetik 2009/95
Status Completed
Phase Phase 1
First received
Last updated
Start date April 21, 2008
Est. completion date February 17, 2012

Study information

Verified date August 2018
Source Ondokuz Mayis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date February 17, 2012
Est. primary completion date July 7, 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ondokuz Mayis University

Outcome

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