Helicobacter Pylori Infection
Conditions
Keywords
periodontal treatment, Initial periodontal therapy, H. pylori
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.
Interventions
DRUGTriple 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)
PROCEDUREprofessional periodontal treatment
periodontal treatment consisting of mechanical periodontal treatment (scaling and root planing) Oral hygiene insruction Periodontal treatment started concurrently with triple therapy
Sponsors
Ondokuz Mayıs University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| eradication rate of gastric H. pylori infection | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| periodontal parameters (Probing depth) | 3 months | probing depth used as a surrogate marker to measure periodontal disease severity |
| Clinical Attachment level | 3 months | used as a surrogate marker to measure severity of the periodontal disease |
| OHI (Oral Hygiene Index) | 3 months | this index used to determine patient oral hygiene status (Greene and Vermillion, 1964) |
| oral H. pylori eradication | 3 months | 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. |
| Plaque index | 3 months | this index used to determine patient oral hygiene status (Silness-Löe) |
| Bleeding on Probing | 3 months | an index give information on inflammation status of periodontal tissues |
| Gingival Index | 3 months | Löe-Silness gingival index |
Outcome results
None listed