Effect of Dental Scaling on Helicobacter Pylori Eradicati... | NCT01816269

Studies
Effect of Dental Scaling on Helicobacter Pylori Eradication and Reinfection

NCT01816269

Sponsor

Goztepe Training and Research Hospital

Status

Unknown status

Last Update Posted

Mar 22, 2013Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Helicobacter Pylori Infection

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

May 2013Estimated

Completion Date

May 2013Estimated

First Submitted Date

Mar 20, 2013

First Submission Date that Met QC Criteria

Mar 21, 2013

First Posted Date

Mar 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2013

Last Update Posted Date

Mar 22, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Celal Ulasoglu, MD Department of Gastroenterology, Goztepe Training and Research HospitalPrincipal Investigator

Lead Sponsor

Goztepe Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients who had received H.pylori eradication treatment will be categorised as eradication and reinfection status and whether dental scaling has any influence on these results.

Detailed Description

Patients over 18 years with no comorbidities especially liver, cardiac and haemorrhagic diathesis and giving informed consent will be categorised according to their status of dental scaling, eradication and reinfection rates of h.pylori.

Statistical examination will include the multiple regression and Chi-Square.

The result will emphasize the influence of dental scaling on eradication (Presence of Hp cure 1-6 months after treatment) and reinfection ( reappearance of Hp 12 months later than the treatment).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with scaling and patients without scaling		No drug
Helicobacter eradicated or non-eradicated

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The eradication and reinfection rates in dental scaled and non-scaled patients.		last 1 year

Secondary Outcomes

Measure	Description	Time Frame
Reinfection rate of patients treated for H.pylori		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients over 18 with h.pylori positivity and received anti-Hp treatment giving informed consent to analyse of their data on this subject.

Exclusion Criteria:

Comorbidities with cardiac, liver and medical contraindication to perform dental scaling.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Eligible population with H.pylori infection and result of treatment based on presence of dental scaling.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GoztepeTRH		Istanbul	Istanbul	34727	Turkey (Türkiye)
GoztepeTRH

Condition Browse Module

MeSH Terms

ID	Term
D000084063	Reinfection

Ancestor Terms

ID	Term
D012008	Recurrence
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided