Comparison of the effectiveness of complementary antibiotic and standard treatment on oral health-related quality of life in patients with chronic periodontitis
Comparison of the effectiveness of complementary antibiotic and standard treatment on oral health-related quality of life in patients with chronic periodontitis
Design
A randomized controlled clinical trial with a parallel group design of 50 patients, double blinded. Randomization will be done due to the using random numbers table
Settings and conduct
This double-blinded clinical trial will be conducted in Dental School of Isfahan University of Medical Sciences.To ensure complete blindness of patients and surgeons, the drug substance is extracted from Amoxicillin capsules. Empty caps are filled by placebo and they are given to patients in control group in addition to the Placebo of Metronidazole. Caps, tablets and bottles are as the same shape in both of the treatment and control groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adult healthy patients over 18 years with moderate to severe generalized chronic periodontitis; bearing at least 16 teeth in oral cavity.
Non-inclusion criteria: Having any other periodontal treatments during the past 6 months; history of allergy to Lidocaine, Amoxicillin and Metronidazole; having Corticosteroid or antibiotic therapy; consuming hormonal drugs and contraceptives; pregnancy in women based on self-expression
Intervention groups
Intervention group: prescription of Amoxicillin 500 mg and Metronidazole 250 mg every 8 hour for 10 days.
Control group: Placebo similar to Amoxicillin capsule and Metronidazole tablet
Main outcome variables
Oral health related quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201221049786N1
Registration date:2021-02-13, 1399/11/25
Registration timing:registered_while_recruiting
Last update:2021-02-13, 1399/11/25
Update count:0
Registration date
2021-02-13, 1399/11/25
Registrant information
Name
Parastoo Parhizkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3439 7916
Email address
parastooparhizkar@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-31, 1399/11/12
Expected recruitment end date
2021-07-14, 1400/04/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of complementary antibiotic and standard treatment on oral health-related quality of life in patients with chronic periodontitis
Public title
The effect of antibiotic therapy on oral health-related quality of life in patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adult healthy patients over 18 years with moderate to severe generalized chronic periodontitis
Bearing at least 16 teeth in oral cavity
Exclusion criteria:
Having any other periodontal treatments during the past 6 months
History of allergy to Lidocaine, Amoxicillin and Metronidazole
Having Corticosteroid or Antibiotic therapy
Consuming hormonal drugs and Contraceptives
Pregnancy in women based on self-expression
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done using the random numbers table. Numbers are read from right side to left side. Even numbers are attributed to treatment group and odd numbers are attributed to the control group. None the patients nor the surgeons will be aware of the randomization results.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blind clinical trial. To ensure complete blindness of patients and surgeons, the drug substance is extracted from Amoxicillin capsules. Empty caps are filled by Placebo and they are given to patients in control group. The Placebo of Metronidazole is also prescribed for patients in control group. The bottles containing the drugs are the same in both of the treatment and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
floor 5; No. west-135; Miremaad 4; 24 alley; South Abounaiem street; Kaveh street
City
Isfahan
Province
Isfehan
Postal code
8193843317
Approval date
2020-11-17, 1399/08/27
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.572
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Oral health related quality of life
Timepoint
Before surgical procedure, 30 and 90 days after antibiotic therapy
Method of measurement
Oral health impact profile(OHIP-14) and Oral impact on daily performance (OIDP) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: prescription of Amoxicillin 500 mg and Metronidazole 250 mg (Daroopakhsh Co. made in Iran) every 8 hour for 10 days
Category
Treatment - Drugs
2
Description
Control group: Placebo similar to Amoxicillin capsule and Metronidazole tablet (made in Pharmacy School of Isfahan University of Medical Sciences) every 8 hour for 10 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan school of dentistry
Full name of responsible person
Jaber Yaghini
Street address
School of dentistry, Isfahan University of Medical Sciences, Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
parastooparhizkar@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nakisa Torabinia
Street address
Dental school, Isfahan University of Medical Sciences, Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
parastooparhizkar@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Jaber Yaghini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school, Isfahan University of Medical Sciences, Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Email
j_yaghini@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Jaber Yaghini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school, Isfahan University of Medical Sciences, Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Email
j_yaghini@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Jaber Yaghini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school, Isfahan University of Medical Sciences, Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Email
j_yaghini@dnt.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Making all of the information undetectable, cases related to the main outcomes studied and complete filled forms and questionnaires will be available.
When the data will become available and for how long
Start of access from 2022
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Usage of these data for systematic reviews and meta analyses are permitted.
From where data/document is obtainable
To gain any information, please contact with email (parastooparhizkar@ymail.com) or phone number (09387300175 ).
What processes are involved for a request to access data/document
After consultation with officials, the desired files will be sent.