Impact of Periodontal Treatment on Gastric Helicobacter Pylori Eradication

Helicobacter Pylori Infection Clinical Trial

Official title:

Periodontal Tedavinin Helikobakter Pilori Eradikasyon ve Rekürrensine Katkısının İncelenmesi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654781
• Other study ID #: OndokusMU1
• Secondary ID: OMUetik 2009/95
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

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