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Completed

NCT Number: NCT03654781

Impact of Periodontal Treatment on Gastric Helicobacter Pylori Eradication

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: Systemic eradication 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

Other names: initial periodontal therapy

Primary outcomes

  1. eradication rate of gastric H. pylori infection

    Time frame: 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 outcomes

  1. oral H. pylori eradication

    Time frame: 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.

  2. periodontal parameters (Probing depth)

    Time frame: 3 months

    probing depth used as a surrogate marker to measure periodontal disease severity

  3. Clinical Attachment level

    Time frame: 3 months

    used as a surrogate marker to measure severity of the periodontal disease

  4. OHI (Oral Hygiene Index)

    Time frame: 3 months

    this index used to determine patient oral hygiene status (Greene and Vermillion, 1964)

  5. Gingival Index

    Time frame: 3 months

    Löe-Silness gingival index

  6. Plaque index

    Time frame: 3 months

    this index used to determine patient oral hygiene status (Silness-Löe)

  7. Bleeding on Probing

    Time frame: 3 months

    an index give information on inflammation status of periodontal tissues

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Periodontal Tedavinin Helikobakter Pilori Eradikasyon ve Rekürrensine Katkısının İncelenmesi

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Aug 31, 2018
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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