Evaluating the histopathology of primary teeth pulp after direct pulp capping by Nano-emulsion containing Propolis and Nigella-sativa: ًRandomized Clinical Trial
Evaluating the histopathology of primary teeth pulp after direct pulp capping by Nano-emulsion containing Propolis and Nigella-sativa: Randomized Clinical Trial
Design
This clinical trial would be run while it includes control group, consisting parallel groups, without blinding, with randomization (block randomization), in order to investigate the efficacy of a herbal extract on 10 patient.
Settings and conduct
This study will be accomplished in the pediatric department of Shahed dental school on children who needs to extract their mandibular canine due to orthodontic reasons (considering the exclusion and inclusion criteria). After cavity preparation and exposing the pulp, the agents (propolis- nigella sativa in intervention or the MTA in control group) would be applied on pulp cells and the teeth will be restored. Subsequently, teeth will be extracted (due to orthodontic treatment plan not due to our study) and their histopathology will be studied.
Participants/Inclusion and exclusion criteria
6 to 9 years old children whose both mandibular canines has to be extracted in future two months due to orthodontic reason (serial extraction); these teeth should not have sever root resorption or caries induced pulpitis
Intervention groups
intervention group: after exposing the tooth pulp, the propolis-nigella sativa extract would be applied on the pul cells.
Control group: after exposing the tooth pulp, the MTA agent would be applied on the pul cells.
Main outcome variables
The inflammatory status of pulp; the amount of cell differentiation in pulp; the amount of dentine bridge formation in pulp.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230312057689N1
Registration date:2023-04-02, 1402/01/13
Registration timing:prospective
Last update:2023-04-02, 1402/01/13
Update count:0
Registration date
2023-04-02, 1402/01/13
Registrant information
Name
Faeze Hamze
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 9210
Email address
f.hamzeh@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the histopathology of primary teeth pulp after direct pulp capping by Nano-emulsion containing Propolis and Nigella-sativa: ًRandomized Clinical Trial
Public title
Effect of Propolis-Nigella sativa extract on primary tooth pulp
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
6-9 years old
without any systemic disorder
no allergy to dental anesthesia
two existing mandibular canine required to be extracted due to orthodontic reason
the patient and his/her parents are eager to participate in the study
Exclusion criteria:
the mentioned canine teeth have root resorption more than apical third
the mentioned canine have irreversible pulpitis
Age
From 6 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the Random allocation rule will be used. According to two main treatment agents including the propolis- nigella sativa or MTA agents, 20 cards will be prepared. On half of the cards (n=10) the A code (regarding the propolis-nigella sativa), and on other half, the B code (regarding the MTA agent) will be written. Afterwards, the cards will be kept in opaque pockets and stored in lottery container. At the beginning of the procedure, the dentist will chose one pocket and according to the code, the MTA or the propolis-nigella sativa will be used for treatment of the first tooth. Selection of the pockets will not have any replacement and the selected pocket will be discarded after recording of the agent.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Ethics committee, Shahed University, Opposite to Imam Khomeini Holy Shrine, Persian Gulf Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2023-02-27, 1401/12/08
Ethics committee reference number
IR.SHAHED.REC.1401.167
Health conditions studied
1
Description of health condition studied
pulpitis (pulp capping)
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
percentage of dentine bridge formation
Timepoint
two months after intervention
Method of measurement
optical microscope
Secondary outcomes
1
Description
The intensity of the presence of inflammatory cells
Timepoint
two months after intervention
Method of measurement
optical microscope
Intervention groups
1
Description
Intervention group: According to the randomization code, cavity preparation will be accomplished on one of the mandibular canine (left or right) until pulp exposure would occur. Thereafter, the propolis-nigella sativa extract (which will be produce by the present researchers) will be applied on dental pulp cells and the tooth will be restored. Two months later, based on orthodontic reason (serial extraction), the mentioned tooth will be extracted (extracting of the tooth is not related to the study process at all).
Category
Treatment - Drugs
2
Description
Control group: According to the randomization code, cavity preparation will be accomplished on one of the mandibular canine (left or right) until pulp exposure would occur. Thereafter, the MTA agent (Dentsply comany, USA) will be applied on dental pulp cells and the tooth will be restored. Two months later, based on orthodontic reason (serial extraction), the mentioned tooth will be extracted (extracting of the tooth is not related to the study process at all).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Department, Shehed Dental School
Full name of responsible person
Faeze Hamze
Street address
Shahed Dental School, Italia St., Vesal Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417755351
Phone
+98 21 8895 9210
Email
faeze.hamze@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Faeze Hamze
Street address
Shahed Dental School, Italia St., Vesal Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417755351
Phone
+98 21 8895 9210
Email
faeze.hamze@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Faeze Hamze
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahed Dental School, Italia St,. Vesal Avenue
City
Tehran
Province
Tehran
Postal code
1417755351
Phone
+98 21 8895 9210
Email
faeze.hamze@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Faeze Hamze
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahed Dental School, Italia St., Vesal Avenue.
City
Tehran
Province
Tehran
Postal code
1417755351
Phone
+98 21 8895 9210
Email
faeze.hamze@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Faeze Hamze
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahed Dental School, Italia St., Vesal Avenue.
City
Tehran
Province
Tehran
Postal code
1417755351
Phone
+98 21 8895 9210
Email
faeze.hamze@gmail.com
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Pat of the data will accessible including the results regarding the histopathology evaluation would be published
When the data will become available and for how long
The access will be available from the Autumn of 2023
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
If the researchers need our available data to conduct similar research.