Investigating the regeneration of adult dental pulp in humans using dental pulp stem cells and a scaffold injected by a specialized robot
Design
Preparation of PRP from the patient's blood/preparation of access and scaffold injection/follow-up in 1, 3, and 6 month intervals/data analysis
Settings and conduct
Since this is a pilot study, among the patients referred to the Semnan Dental Faculty, we will examine one male aged 12 to 18 years with no underlying or hereditary disease and whose tooth has irreversible pulpitis. One person will select another sample if there is an error in the first sample or the patient does not cooperate.
Participants/Inclusion and exclusion criteria
Have the entry criteria: lower 5th tooth, age between 12 and 18 years, male gender, diagnosis of irreversible root canal pulpitis but without abscess, without fracture, remaining healthy tooth structure at the margin of alveolar bone and absence of periapical radiolucency by X-ray analysis X-rays and dental crowns do not need to be covered.
Intervention groups
Irreversible root canal pulpitis but without abscess
Main outcome variables
Regenerative agent/pulpal test/ Examination of changes in the periapical region
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230515058203N1
Registration date:2024-07-04, 1403/04/14
Registration timing:prospective
Last update:2024-07-04, 1403/04/14
Update count:0
Registration date
2024-07-04, 1403/04/14
Registrant information
Name
Sahar Maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3346 3925
Email address
saharmlki2001@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating regeneration of adult dental pulp in humans using dental pulp stem cells and scaffold injection
Public title
Investigating adult dental pulp regeneration in humans using dental pulp stem cells and scaffold injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lower 5th tooth
Age between 12 and 18 years
Male sex
Diagnosis of irreversible root canal pulpitis but without abscess
Without breakage
The remaining healthy tooth structure in the margin of the alveolar bone and the absence of periapical radiolucency by X-ray analysis and tooth crown do not need veneer.
Exclusion criteria:
Age
From 12 years old to 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
1
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences and Health Services,Basij Boulevard,
City
semnan
Province
Semnan
Postal code
35147-99442
Approval date
2024-05-18, 1403/02/29
Ethics committee reference number
IR.SEMUMS.REC.1403.010
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Examination of changes in the periapical region
Timepoint
1,3,6 months
Method of measurement
Radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Regeneration of adult dental pulp in humans using dental pulp stem cells and scaffold injection
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental College
Full name of responsible person
Dr. Maryam Jalili Sadrabad
Street address
17 Shahrivar Boulevard - School of Dentistry
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3332 4700
Email
dent@semums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Maryam Jalili Sadrabad
Street address
17 Shahrivar Boulevard - School of Dentistry
City
semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3332 4700
Email
saharmlki2001@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
1
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Maryam Jalili Sadrabad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry,17 Shahrivar Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3332 4700
Email
dr.njalili@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Maryam Jalili Sadrabad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry,17 Shahrivar Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3332 4700
Email
dr.njalili@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sahar Maleki
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
School of Dentistry,17 Shahrivar Blvd., Semnan
City
semnan
Province
Semnan
Postal code
3518794431
Phone
+98 919 956 0716
Email
saharmlki2001@gmail.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
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