Evaluation the efficiency of triple therapy vs combined periodontal and triple therapy in patient with H. pylori positive in the subgingival biofilm.
Design
Two arm parallel group non randomized clinical trial
Settings and conduct
The study was performed in 102 patients with peptic ulcer or dyspepsia, positive for gastric H. pylori infection who refer to gastrointestinal clinic of Alzahra hospital. Individuals who had oral infection were assigned non-randomly to two sets of treatment: a 14-days course of triple therapy (antibiotics, antimicrobials, and proton pump inhibitors) with periodontal therapy (n=32) (G+O+tp) or triple therapy alone groups(n=32) (G+O-t). In all participants the efficacy of H. pylori eradication from the stomach was evaluated 4 weeks after cessation of the triple therapy by H. pylori stool antigen test.
Participants/Inclusion and exclusion criteria
Peptic ulcer or dyspepsia positive for Helicobacter pylori infection based on stool Helicobacter pylori antigen test evaluation
Intervention groups
Test group: course of triple therapy and nonsurgical periodontal therapy
control group: course of triple therapy
Main outcome variables
Eradication of gastric Helicobacter Pylori
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110109005570N9
Registration date:2021-04-14, 1400/01/25
Registration timing:registered_while_recruiting
Last update:2021-04-14, 1400/01/25
Update count:0
Registration date
2021-04-14, 1400/01/25
Registrant information
Name
Parichehr Behfarnia
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1666 1707
Email address
behfarnia@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University Of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2021-04-22, 1400/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Systemic Therapy in patients with dyspepsia with and without Periodontal Therapy for Eradication of Helicobacter Pylori Infection.
Public title
The Treatment Effect of Nonsurgical Periodontal Therapy for Eradication of Helicobacter Pylori Infection Following Systemic Therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Peptic ulcer or dyspepsia positive for helicobacter pylori infection based on stool helicobacter pylori antigen test evaluation or serology
Exclusion criteria:
Suffering from MALT
Zolinger Elison syndrome
GI tract cancer
Liver and kidney disease
Tacking antibiotics or probiotic in past 4 weeks or any contraindication for tacking medicinal diet
Immunologic disease
Pregnancy
History of upper GI tract surgery
History of eradication of Helicobacter pylori infection
History of tacking PPI
Do not take medication regularly(20% or more)
Serious side effect as a result of tacking medication
Request a patient to leave the study
Failure for oral hygiene.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committe of Isfahan University Of Medical Sciences
Street address
Hezar Jarib St
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2016-06-14, 1395/03/25
Ethics committee reference number
IR.MUI.REC.1396.3.174
Health conditions studied
1
Description of health condition studied
Peptic ulcer or dyspepsia
ICD-10 code
K27
ICD-10 code description
Acute peptic ulcer
Primary outcomes
1
Description
The presence of H. pylori in GI tract and its eradication
Timepoint
Base line(before treatment), 1 months after treatment
Method of measurement
Stool H. pylori antigen test
2
Description
Presence of H. pylori in dental plaque
Timepoint
Base line(before treatment)
Method of measurement
Rapid Urease Test
Secondary outcomes
1
Description
Probing depth
Timepoint
Base line(before treatment),1 months after treatment
Method of measurement
Probing by Williams prob, from gingival margin to depth of pocket
2
Description
Plaque index
Timepoint
Base line(before treatment) and 1 months after treatment
Method of measurement
Plaque index of silness and loe
Intervention groups
1
Description
Triple therapy (G +O +tp)include pantoprazol 40mg q2d,Bismuth sub-citrate 240mg q2d,amoxycillin 1gr q2d, Clarithromycin 500 for 14 days.. non surgical treatment consist of oral hygiene instruction and scaling and root planing.
Category
Treatment - Drugs
2
Description
Nonsurgical periodontal therapy : scaling and root planning
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Clinics of Isfahan Medical University
Full name of responsible person
Parichehr Behfarnia
Street address
Hezar jarib, Isfahan University Of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3792 5570
Email
Alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor For Research Of Isfahan University Of Medical Sciences
Full name of responsible person
Dr shaghayegh haghju
Street address
Hezar Jarib, Vice chancellor For Research Of Isfahan University Of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5564
Email
research@mui.ac.ir
Grant name
تحقیقاتی
Grant code / Reference number
396174
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor For Research Of Isfahan University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirin Rostami
Position
Periodontist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jarib, Dental School, Isfahan University Of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Fax
Email
shirinrostami.dnt@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jarib, Dental School, Isfahan University Of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Fax
Email
behfarnia@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirin Rostami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar jarib, Dental School, Isfahan University Of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5542
Fax
Email
shirinrostami.dnt@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available