Evaluation of the effect of ozone gel on the clinical and radiographic success of primary molars pulpotomy with ferric sulfate
Design
A clinical trial with the parallel intervention group, one-way blind, randomized, random sampling method. The randomization method is simple and with a random number table. Twenty-five patients were selected and one tooth per person was considered as a control and the other tooth was considered for treatment. In the control group, normal pulpotomy using 15.5% ferric sulfate, and in the experimental group, ozone gel will be used as a disinfectant before chamber ferric sulfate. In both groups, they will eventually be treated with Zonalin and the final restoration of the crown will be done with SSC.
Settings and conduct
The study will be performed in the pediatric department, Tabriz Dental School. Control teeth, normal pulpotomy using 15.5% ferric sulfate, and test teeth ozone gel will be used as a disinfectant before the ferric sulfate chamber. Evaluation of treatment success by a pediatric dentist who is unaware of the type of treatment (one-blind) will be assessed during a 6-month follow-up.
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. Exit: Favism- hyperthyroidism -Anemia -Ozone sensitivity- Hemorrhagic disease
Intervention groups
In the control group, normal pulpotomy using 15.5% ferric sulfate, and in the experimental group, ozone gel will be used as a disinfectant before chamber ferric sulfate. In both groups, they will eventually be treated with Zonalin and the final restoration of the crown will be done with SSC.
Main outcome variables
Clinical success
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190514043585N3
Registration date:2021-12-29, 1400/10/08
Registration timing:registered_while_recruiting
Last update:2021-12-29, 1400/10/08
Update count:0
Registration date
2021-12-29, 1400/10/08
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
2021-12-28, 1400/10/07
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of ozone gel on the clinical and radiographic success of ferric sulfate primary molar pulpotomy
Public title
Evaluation of the effect of ozone gel on the clinical and radiographic success of ferric sulfate primary molar pulpotomy
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
Lack of symptoms of necrosis or inflammation of the root pulp in radiography
Lack of symptoms of external root resorption in radiography
Having primary 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:
25
More than 1 sample in each individual
Number of samples in each individual:
2
In 25 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
The sampling method is randomly Available among Individuals referring to the 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 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
2021-08-30, 1400/06/08
Ethics committee reference number
IR.TBZMED.REC.1400.514
Health conditions studied
1
Description of health condition studied
Primary tooth caries
ICD-10 code
K02
ICD-10 code description
Dental caries
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
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the experimental group, the procedure will be as follows: The desired tooth will be anesthetized and isolated with a Rubber Dam. After removing all caries and debris, an access cavity will be created. The contents of the coronary pulp tissue will be removed and then ozone gel (Vitomex) will be placed for disinfection After a few minutes of melting the gel, 15.5% ferric sulfate (UltraDent Astingedent) is placed in place and finally, zonalin (Zoliran) will be applied. and the final restoration will be done in the same meeting. This gel can stay at room temperature for months, but to maintain the highest performance, it must be stored in the refrigerator at 15 degrees Celsius or less. All steps will be performed by the student participating in the study under the supervision of the supervisor. Clinical success will be assessed by a pediatrician during a 6-month clinical follow-up. The pediatrician is unaware of the type of treatment given to each patient.
Category
Treatment - Other
2
Description
Control group: Normal pulpotomy using ferric sulfate. In the control group, the procedure will be as follows: The desired tooth will be anesthetized and isolated with a Rubber Dam. After removing all caries and debris, an access cavity will be created. The contents of the coronal pulp tissue will be extracted. 15.5% ferric sulfate (UltraDent Astingedent) will be placed in place and finally, zonalin (Zoliran) will be placed and the final repair will be done in the same session. In the control group, all the steps performed for the experimental group will be repeated, except Ozone gel will not be used for disinfection and eventually the crown of the teeth will be regenerated. All steps will be performed by the student participating in the study under the supervision of the supervisor. Clinical success will be assessed by a pediatrician during a 6-month clinical follow-up. The pediatrician is unaware of the type of treatment given to each patient.
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
Parviz Shahabi
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
parvizshahabi@gmail.com
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
Ph.D.
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
Ph.D.
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
Ph.D.
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