Evaluation of the Success of Ozone gel as capping material between two appointments in the pulpectomy of necrotic primary molar teeth
Design
Clinical trials, with Parallel Groups, single-blinded and Randomized. Sampling Method is random. The randomization Method is simple and our Tool for randomization is randomized Number Chart. 56people were divided into two groups. The control group, normal pulpotomy using formocresol as a pulp covering material between two sessions in pulpectomy of the primary molar necrosis and the test group will receive ozone as a pulp covering material between two sessions. The two groups will ultimately fill the root canals with ZOE material as the final filling material of the canal.
Settings and conduct
The study will be performed in the pediatric department, Tabriz Dental School. The ozone-impregnated cotton ball will be placed in a pulp chamber at a concentration of 1: 5. During the second session, the teeth will be isolated with Rubber Dam and the cotton bullet will be removed. In the control group, all the steps performed for the test group will be repeated, except that formocosol will be used as a pulp covering agent between two sessions. A pediatrician who is unaware of the type of treatment (single- blind) will be examined during a 6-month-long fallopian.
Participants/Inclusion and exclusion criteria
Entrance criteria: ages 4 to 8 years with primary molar necrosis with intraoral enlarged vestibular
Entrance criteria: Favism- hyperthyroidism -Anemia -Ozone sensitivity Hemorrhagic disease
Intervention groups
Control group, normal pulpotomy using formocresol as a pulp covering material between two sessions in pulpectomy of the primary molar necrosis and the test group will receive ozone as a pulp covering material between two sessions.
Main outcome variables
Clinical success; Radiographic success
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190514043585N1
Registration date:2019-05-25, 1398/03/04
Registration timing:retrospective
Last update:2019-05-25, 1398/03/04
Update count:0
Registration date
2019-05-25, 1398/03/04
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
2018-12-11, 1397/09/20
Expected recruitment end date
2019-05-10, 1398/02/20
Actual recruitment start date
2018-12-11, 1397/09/20
Actual recruitment end date
2019-05-10, 1398/02/20
Trial completion date
2019-05-10, 1398/02/20
Scientific title
Evaluation of the Success of Ozone gel as capping material between two appointments in the pulpectomy of necrotic primary molar teeth
Public title
Evaluation of the Success of Ozone gel in the pulpectomy of necrotic primary molar teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ages 4 to 8 years
The ability to cooperation for treatment
The deciduous molar necrosis with intraoral enlarged vestibular (without drainage)
having primary radiography
with a very high mild PDL in radiography
parental satisfaction for participation in the study
Exclusion criteria:
Deficiency of glucose 6 phosphate dehydrogenase or favism
hyperthyroidism
Anemia
Ozone sensitivity
Hemorrhagic disease
deciduous molars with irreparable crown
Mobility and movement greater than 1 mm
Existence of internal or external analysis in radiography
Root less than 3/2
Age
From 4 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
56
Actual sample size reached:
56
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 and the Unit is individual, 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. None of the Patients will be informed about another Patient's treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants do not know that different types of treatment are being studied. They are also totally blinded to the information of the other Participants.
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
2019-05-16, 1398/02/26
Ethics committee reference number
IR.TBZMED.REC.1398.063
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
Control group: Normal pulpectomy using formocresol as a pulp covering agent between two sessions in pulpectomy of primary molar necrosis
Category
Treatment - Drugs
2
Description
Intervention group: pulpectomy using ozone as a pulp covering agent between two sessions in pulpectomy of primary molar necrosis
Category
Treatment - Drugs
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. Abolghasem Jouyban
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
Associate 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
Associate 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