Evaluation of the effect of full mouth disinfection therapy on the recurrence of Helicobacter pylori infection in patients referred to Sayad shirazi hospital in Gorgan
Objectives: To investigate the effect of full mouth disinfection therapy on eradication of Helicobacter pylori from the stomach of the people with gastric ulcer.
Design: 40 patients with gastric ulcer caused by Helicobacter pylori are selected and divided into two intervention and control groups.
Participants including major eligibility criteria: People older than 18 years; at least 10 teeth with the exception of remaining roots and wisdom teeth; gingival index less than 3mm; pocket depth less than or equal to 4 mm; attachment loss less than 5 mm.
Intervention: For both treatment groups, routine helicobacter pylori eradication drugs are prescribed. In the intervention group, full mouth oral disinfection is also done .
Main outcome measures: Eradication of Helicobacter pylori infection of the stomach of both groups are assessed 4 months after.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080530744N2
Registration date:2017-10-24, 1396/08/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-24, 1396/08/02
Registrant information
Name
Elham Fakhari
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3227 2253
Email address
dr.fakhari@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Golestan University of Medical sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of full mouth disinfection therapy on the recurrence of Helicobacter pylori infection in patients referred to Sayad shirazi hospital in Gorgan
Public title
Evaluation of the effect of full mouth disinfection therapy on the recurrence of Helicobacter pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Major entry requirements: People older than 18 years; at least 10 teeth with the exception of remaining roots and wisdom teeth; gingival index less than 3 mm; pocket depth less than or equal to 4 mm; attachment loss less than 5 mm.
Patient withdrawal conditions from the study : Consumption of antibiotic or proton pump inhibitor in the past month; Radiation therapy patients; Patients with a history of sensitivity to amoxicillin, clarithromycin, bismuth, omeprazole and chlorhexidine; Patients who once received systemic Helicobacter pylori infection therapy ; Patients with systemic diseases; Pregnant and nursing mothers; smoking
Age
From 99 years old to 57 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Golestan University of Medical Sciences
Street address
Across Minagol, Valieasr Streets
City
Gorgan
Postal code
-49169-53363
Approval date
2017-08-16, 1396/05/25
Ethics committee reference number
IR.goums.REC.1396.131
Health conditions studied
1
Description of health condition studied
Stomach ulcer caused by Helicobacter pylori
ICD-10 code
-k25
ICD-10 code description
-disease of stomach
Primary outcomes
1
Description
helicobacter pylori induced gastritis
Timepoint
at baseline
Method of measurement
Urease test and expert opinion
Secondary outcomes
1
Description
-recurrence of helicobacter induced gastritis
Timepoint
-4 months after treatment
Method of measurement
-respiratory urease test
Intervention groups
1
Description
Intervention group: Routine treatment of Helicobacter pylori including bismuth tablet 525 mg (hepatica-Iran) 4 times a day for 2 weeks, Clarithromycin 500 mg tablet (Tehran Chem-Iran) twice a day for 2 Weeks, 20 mg omeprazole capsule (Dr. Obiidi-Iran) 2 times a day for 2 weeks, Amoxicillin 500 mg capsule (Tehran Chem. Iran) 4 times a day for 2 weeks, full mouth oral disinfection therapy including 1- Scaling and root planning in 24-hour intervals with ultrasonic and hand instruments 2- Periodontal pockets irrigation with chlorhexidine (0.12%). 3- Brushing the surface of the tongue with chlorhexidine 0.12% 4- Using chlorhexidine (0.12%) as an oral mouthwash
Category
Treatment - Other
2
Description
Intervention in the control : Routine drug treatment of Helicobacter pylori , including bismuth tablet 525 mg (healing-Iran) 4 times a day For 2 weeks, Clarithromycin Tablet 250 mg (Tehran Chem. Iran) twice a day for 2 weeks, omeprazol capsule 20 mg (Obeidi-Iran) twice a day for 2 weeks, amoxicillin capsule 500 mg(Tehran Chem-Iran) 4 times a day for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Gastroenterology Sayyad Shirazi Hospital
Full name of responsible person
Dr Taghi Amiriani
Street address
Sayyad Shirazi Street
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice Chancellor for research, Golestan University of Medical Sciences
Full name of responsible person
Dr. Ramzani
Street address
Faculty of Dentistry, across Minagol, Valieasr Street
City
Gorgan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice Chancellor for research, Golestan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of dentistry, Golestan University of Medical Sciences
Full name of responsible person
Dr. Elham Fakhari
Position
Assistant Professor of Periodontology, Faculty of Dentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, across Minagol, Valieasr Street
City
Gorgan
Postal code
Phone
+98 17 3255 5700
Fax
Email
dr.fakhari@goums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences, Faculty of Dentistry
Full name of responsible person
Dr.Elham Fakhari
Position
Assistant Professor of Periodontology, Faculty ofDentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, across Minagol, Valieasr Street
City
Gorgan
Postal code
Phone
+98 17 3255 5700
Fax
Email
dr.fakhari@goums.ac.irfakhari_85@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr Elham Fakhari
Position
Assistant professor
Other areas of specialty/work
Street address
Faculty of Dentistry, across Minagol, Valieasr Street
City
Gorgan
Postal code
Phone
+98 17 3255 0700
Fax
Email
Dr.fakhari@goums.ac.irFakhari_85@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)