Helicobacter Pylori InfectionScaling and HpNCT01816269
Effect of Dental Scaling on Helicobacter Pylori Eradication and Reinfection
An observational study of Helicobacter Pylori Infection, run by Goztepe Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- How many people
- 300 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Mar 2013to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible population with H.pylori infection and result of treatment based on presence of dental scaling.
Who may be able to join
- Patients over 18 with h.pylori positivity and received anti-Hp treatment giving informed consent to analyse of their data on this subject.
Who cannot join
- Comorbidities with cardiac, liver and medical contraindication to perform dental scaling.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
GoztepeTRH
Istanbul, Istanbul, 34727
GoztepeTRH
Istanbul
About this study
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.
Read the 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).
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Dental scaling, Eradication, Reinfection, Helicobacter status
- Medical subject headings
- Reinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with scaling and patients without scaling | No drug | |
| Helicobacter eradicated or non-eradicated | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The eradication and reinfection rates in dental scaled and non-scaled patients.
Measured: last 1 year
Secondary outcomes (1)
Reinfection rate of patients treated for H.pylori
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goztepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celal Ulasoglu, Goztepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816269
- Sponsor's protocol ID
- cu1959
- Acronym
- Scaling and Hp
- Status last verified
- Mar 2013
- First submitted
- 20 Mar 2013
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dental Scaling on Helicobacter Pylori Eradication and Reinfection
- ClinicalTrials.gov ID
- NCT01816269
- Acronym / sponsor ID
- Scaling and Hp / cu1959
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Dental scaling, Eradication, Reinfection, Helicobacter status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Goztepe Training and Research HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with scaling and patients without scaling | – | –No drug |
| Helicobacter eradicated or non-eradicated | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible population with H.pylori infection and result of treatment based on presence of dental scaling.
Key inclusion criteria (1 listed)
- Patients over 18 with h.pylori positivity and received anti-Hp treatment giving informed consent to analyse of their data on this subject.
Key exclusion criteria (1 listed)
- Comorbidities with cardiac, liver and medical contraindication to perform dental scaling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The eradication and reinfection rates in dental scaled and non-scaled patients.
Time frame: last 1 year
1 secondary outcome
Reinfection rate of patients treated for H.pylori
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection, run by Goztepe Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The eradication and reinfection rates in dental scaled and non-scaled patients. (time frame: last 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2013.