Evaluation of the effect of ozon gel on the clinical and radiographic success rate of partial pulpectomy of primary molars with irriversible pulpitis
Design
Clinical trials, with Parallel Groups, single-blinded and Randomized and sampling method is random. The randomization method is simple and with number Chart. 50 people were selected and one tooth per person was considered as a control and another tooth was considered for treatment. Control tooth, dental restoration with amalgam or with ssc and test teeth will be disinfected with a paper soaked in ozone gel. The channels will be filled with ZOE.
Settings and conduct
The study will be performed in the pediatric department, Tabriz Dental School.Control tooth, dental restoration with amalgam or with ssc and test teeth will be disinfected with a paper soaked in ozone gel. The channels will be filled with ZOE.A pediatrician who is unaware of the type of treatment (single- blind) will be examined during a 6-month-long followup.
Participants/Inclusion and exclusion criteria
Entrance : Ages 4 to 8 years- Double sided molar with irreversible pulpitis requires pulpectomy- -Lack of symptoms of external root resorption-Possibility of crow restoration
Entrance: Favism- hyperthyroidism -Anemia -Ozone sensitivity- Hemorrhagic disease
Intervention groups
Intervention: The canals will be disinfected with a paper soaked in ozone gel. The channels will be filled with ZOE.
Control: All steps performed for the test group will be repeated, except that only routine canal washing solutions containing 1% hypochlorite and normal saline will be used. Eventually, the tooth crown will be restored with amalgam or ssc.
Main outcome variables
Clinical success; Radiographic success
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190514043585N2
Registration date:2020-06-29, 1399/04/09
Registration timing:registered_while_recruiting
Last update:2020-06-29, 1399/04/09
Update count:0
Registration date
2020-06-29, 1399/04/09
Registrant information
Name
Seyedeharezou Ghoreyshizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3330 8948
Email address
ghoreyshizadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-29, 1399/04/09
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of ozon gel on the clinical and radiographic success rate of partial pulpectomy of primary molars with irriversible pulpitis
Public title
Evaluation of the effect of ozon gel on the clinical and radiographic success rate of
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 4 to 8 years
The ability to cooperation for treatment
Double sided molar with irreversible pulpitis requires pulpectomy
Having primary radiography
Lack of symptoms of necrosis in radiography
Lack of symptoms of external root resorption in radiography
Possibility of crown restoration
Parental satisfaction for participation in the study
Exclusion criteria:
Deficiency of glucose 6 phosphate dehydrogenase or favism
Hyperthyroidism
Anemia
Ozone sensitivity
Hemorrhagic disease
Age
From 4 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
100
More than 1 sample in each individual
Number of samples in each individual:
2
In 50 children who require partial pulpectomy of bilateral first molar or partial pulpectomy of bilateral second molar in the maxilla or mandible
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling Method is randomly Available among Individuals referring to pediatric Department of Tabriz Dental faculty. The randomization Method is simple . Our Tool for randomization is the randomized Number Chart. Furthermore, the Allocation of treatment to Patients is done Randomly. To do this, the types of treatment are identified with code A (control) and B (case) and then the sealed in Envelopes that will be placed in a Box and stirred. Then they are randomly chosen from the Box and after observing the code, the treatment is given to the Patient. One person's tooth was considered as a control and another tooth for treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The pediatrician is unaware of the outcome of the treatment and the type of disinfectant used for each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-06-08, 1399/03/19
Ethics committee reference number
IR.TBZMED.REC.1399.233
Health conditions studied
1
Description of health condition studied
Necrotized primery molars
ICD-10 code
K02.5
ICD-10 code description
Caries with pulp exposure
Primary outcomes
1
Description
Clinical success
Timepoint
6 months
Method of measurement
A checklist containing information -1 No pain, 2-No sensitivity to Percussion 3-Missing or increased mobility 4- No opening of the sinus 5. No withdrawal of pushy exudates from the gingival margin
2
Description
Radiological success
Timepoint
6 months
Method of measurement
Radiography and completing the checklist 1 - Radiolucency has not been created in the periapical or fork 2. There are no symptoms of internal and external resorption.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Disinfection of canal by ozon gel
Category
Treatment - Other
2
Description
Control group: Disinfection of canal by routine canal washing solutions containing 1% hypochlorite and normal saline
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Department, Faculty of Dentistry, Tabriz
Full name of responsible person
Seyedeh Arezou Ghoreyshizadeh
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
ghoreyshizadeha@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Prof. Mohammad samiei
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
ghoreyshizadeha@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Seyedeh Arezou Ghoreyshizadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
ghoreyshizadeha@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyedeh Arezou Ghoreyshizadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
ghoreyshizadeha@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyedeh Arezou Ghoreyshizadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
ghoreyshizadeha@tbzmed.ac.ir
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
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
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