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Regeneration of dental pulp complex in closed apex necrotic teeth using fibrin hydrogel.

Protocol summary

Study aim
The use of dental pulp complex in closed apex necrotic teeth with using fibrin hydrogel for regeneration of dental pulp.
Design
The participants who meet inclusion criteria will be randomized in two groups, the experimental group and the control group . The outcome will be assessed during recall examinations and after extraction, included clinical examinations, taking dental x-ray and histological tests. Selection and exclusion of subjects (experimental n:۵, control n:۵). If the root canal treatment with stem cells is successful, the teeth will be healthy like other teeth, and if the root canal treatment is not successful, the standard root canal treatment will be done free of charge.
Settings and conduct
Tehran University of Medical Sciences- Regenerative Medicine and stem cell Research Center The study is designed as a Clinical trial study. The participants who meet inclusion criteria will be randomized in two groups.
Participants/Inclusion and exclusion criteria
The main inclusion criteria of the study before randomization: Patients with single-rooted teeth number 1, 2 and 3 with irreversible pulpitis (need for root canal treatment) The main exclusion criteria of the study before randomization: Patients with perforation of the tooth from the pulp cavity through the tip of the root, which exposes the tissue to the material in the oral cavity.
Intervention groups
The experimental group received the proposed intervention (root restoration method using fibrin hydrogel) and the control group received the standard root restoration treatment .
Main outcome variables
Pulp evaluation will done by radiographic and clinical examination. Signs, symptoms, apical healing, and vitality will be compared with preoperative examinations. To evaluate odontoblasts and fibroblasts, extracted teeth will be used in-vitro, and the expression of genes will be evaluated in a3D environment.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230513058168N1
Registration date: 2023-06-11, 1402/03/21
Registration timing: registered_while_recruiting

Last update: 2023-06-11, 1402/03/21
Update count: 0
Registration date
2023-06-11, 1402/03/21
Registrant information
Name
Jafar Ai
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4305 2000
Email address
jafar_ay2000@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-14, 1402/02/24
Expected recruitment end date
2023-10-14, 1402/07/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Regeneration of dental pulp complex in closed apex necrotic teeth using fibrin hydrogel.
Public title
Restoration of dental pulp using hydrogel
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients must be systemically healthy, Class I dental category Involved teeth must have no periodontal disease detectable by periodontal examination. Patients must present with radiographic signs of endodontic disease (i.e., necrotic pulp with periapical radiolucency) One-rooted teeth number ۱, ۲ and ۳ with irreversible pulpitis (need root canal treatment)".
Exclusion criteria:
Presence of any disease or medication that alters the immune system or interferes with healing ability Smokers (more than ۱۰ cigarettes per day) External or internal tooth resorption Tooth perforation from the pulp cavity through the tip of the root exposing the tissue to material in the oral cavity. Pregnant or nursing mothers because hormonal factors may influence the condition. Allergies or adverse reactions to local anesthetic medications Patients under the age of ۱۸ Patients with an ASA Classification II or higherI. Cardiovascular Disease Disable or mental illness Osteoporosis
Age
From 18 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
The study is designed as a Clinical trial study. The participants who meet inclusion criteria will be randomized in two groups, the experimental group receives the proposed intervention a (regenerative endodontic procedure using Fibrin hydrogel), and the control group receives conventional regeneration therapy (blood clot). The outcome will be assessed during recall examinations and after extraction, included clinical examinations, taking dental x-ray and histological tests. Selection and exclusion of subjects (experimental n:۵, control n:۵). If the root canal treatment with stem cells is successful, the teeth will be healthy like other teeth, and if the root canal treatment is not successful, the standard root canal treatment will be done free of charge.
Blinding (investigator's opinion)
Double blinded
Blinding description
10 patients are placed in two groups of 5 for study. The studied groups will include 5 people receiving the root restoration method using fibrin hydrogel, 5 people receiving standard root canal treatment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran National committee for Ethics in Biomedical research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2023-05-13, 1402/02/23
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.026

Health conditions studied

1

Description of health condition studied
teeth with with irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis

Primary outcomes

1

Description
Radiographic observations
Timepoint
Before the intervention and 1 week, 3 months and 6 months after the intervention
Method of measurement
Radiographic observations

2

Description
Examination of signs of apical healing and dental vital signs
Timepoint
Before the intervention and 1 week, 3 months and 6 months after the intervention
Method of measurement
Routine dental vital test methods.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Suggested root canal treatment intervention using 1 million cord stem cells in 300 microliters of fibrin hydrogel containing 300 micrograms of exosome and growth factor (NGF - VEGF) per dental canal.
Category
Treatment - Other

2

Description
Control group: Standard root canal treatment
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Neda Bayat
Street address
No.88, Italya St., Ghods St., Keshavarz Blvd., Tehran ,school of advanced technologies in medicine Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Email
bayat.neda@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of San Francisco
Full name of responsible person
MiKe Sabeti
Street address
707 Parnassus Ave, #3226 San Francisco CA 94143
City
San Francisco
Postal code
94143
Phone
+1 415-476-0822
Email
sabeti۲۰۰۱@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of San Francisco
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Foreign
Category of foreign source of funding
UN agencies and international organizations
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Neda Bayat
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
NO. 88, Italya St., Ghods St., Keshavarz Blvd., Tehran, school of advanced technologies in medicine, Tehran university of medical sciences
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Email
bayat.neda@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Jafar Ai
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
NO. 88, Italya St., Ghods St., Keshavarz Blvd., Tehran, School of Advanced Technologies in Medicine Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Fax
Email
jafar_ay2000@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Mokhtari
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
NO. 88, Italya St., Ghods St., Keshavarz Blvd., Tehran, School of Advanced Technologies in Medicine Tehran university of medical sciences
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Email
m.mehdimokhtari@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
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