evaluation of The effect of chlorhexidine mouthwash on gingival health around stainless steel veneers in deciduous molars
Design
Clinical trial with control group with parallel and double-blind groups, phase three on 58 patients
Settings and conduct
Ahvaz Jundishapur Dental School researcher and measurer were blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The child is over 4 years old and has the ability to spit mouthwash, has no history of antibiotics in the past 4 weeks, no signs of periodontal disease and interdental bone resorption on the radiograph of the patient, no use of orthodontic applique, history Has no systemic disease, no history of fluoride use in the last 2 weeks
Exclusion criteria: non-cooperation of the child, use of antibiotics during treatment, performing other dental treatments in other medical centers by the patient
Intervention groups
The intervention group is given chlorhexidine after treatment (putpotomy and veneer of deciduous teeth) to evaluate the effect of this mouthwash on improving gingivitis.in control group after same treatment no mouthwash prescribe.
Main outcome variables
gingival index,Oral hygiene index (OHIS), probing depth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210417050994N1
Registration date:2021-05-24, 1400/03/03
Registration timing:registered_while_recruiting
Last update:2021-05-24, 1400/03/03
Update count:0
Registration date
2021-05-24, 1400/03/03
Registrant information
Name
shiva motaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3865 4216
Email address
shivamotaghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-10, 1400/02/20
Expected recruitment end date
2021-06-10, 1400/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of chlorhexidine mouthwash on gingival health around stainless steel crowns on deciduous molars
Public title
evaluation of the effect of chlorhexidine mouthwash on gingival health around stainless steel crowns on deciduous molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age more than 4 year-old
ability to spit
had not uses antibiotics in the last 4 weeks
doesn't have periodontal diseases and inter proximal bone lost
not using orthodontic appliances
doesn't have systemic diseases
had not uses fluoride in the last 2weeks
Exclusion criteria:
lack of cooperation
using antibiotics during the treatment
being under treatment in other dentistry departments
Age
From 4 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and outcome assessor does not know whether the patient has used mouthwash or not
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of ahvaz jundishapur university of medical sciences
Street address
golestan blvd. jundishapur university
City
ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Approval date
2021-04-18, 1400/01/29
Ethics committee reference number
IR.AJUMS.REC.1400.036
Health conditions studied
1
Description of health condition studied
gingivities
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
Gingival Index (Gingival Index): 0- Healthy gums 1- Low inflammation: low discoloration, low edema, no bleeding 2- Moderate inflammation: gingival redness, edema and shine, bleeding gums during probing 3- Severe inflammation: Distinct redness and edema, sores, tendency for spontaneous bleeding of the gums.
Timepoint
two weeks after using chlorhexidine mouthwash
Method of measurement
observational
2
Description
OHIS: - 1- Soft debris that covers less than one third of the tooth surface 2- Soft debris that covers between one third and two thirds of the tooth surface 3- Soft debris that covers more than two thirds of the tooth surface
Timepoint
two weeks after using chlorhexidine mouthwash
Method of measurement
observational
3
Description
probing depth
Timepoint
two weeks after using chlorhexidine mouthwash
Method of measurement
by using periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group that used chlorhexidine mouthwash for two weeks after pulpotomy and stainless steel coating treatment.the 012 percent vi- one chlorhexidine is pour on the cotton and apply on the teeth gingiva.this should be done once in a day
Category
Treatment - Other
2
Description
Control group: the group that does not use chlorhexidine mouthwash
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
ahvaz jundishapur dentistery school
Full name of responsible person
shiva motaghi
Street address
Golestan bldv.Jundishapur university of medical sciences
City
ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 51 3865 4216
Email
info@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
دکتر مهدی احمدی مقدم
Street address
Golestan bldv.Jundishapur university of medical sciences
City
ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3865 4216
Email
info@ajums.ac.ir
Grant name
Ahwaz university of medical sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
shiva motaghi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Golestan bldv.Jundishapur university of medical sciences
City
ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3865 4216
Email
shivamotaghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
shiva motaghi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Golestan bldv.Jundishapur university of medical sciences
City
ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 51 3865 4216
Email
shivamotaghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
shiva motaghi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Golestan bldv.Jundishapur university of medical sciences
City
ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 51 3865 4216
Email
shivamotaghi@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
not clear
When the data will become available and for how long
not clear
To whom data/document is available
wheo our article be published
Under which criteria data/document could be used
not clear
From where data/document is obtainable
not clear
What processes are involved for a request to access data/document