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Comparative evaluation of the success rate of applying formocresol, 3Mixtatin and Mineral trioxide aggregatein pulpotomy of primary molars

Protocol summary

Summary
The rationale for pulpotomy of primary molars is based on the assumption that inflammation is limited to the coronal portion of the dental pulp and that the radicular pulp has the potential to heal. Since 1950, formocresol (FC) has been widely used as a pulp dressing material for pulpotomy of primary molars. However, many concerns have been raised about the potential mutagenicity and carcinogenicity of FC in humans and therefore alternative pulpotomy agents have been proposed. In the present study, we suggest using 3Mixtatin, a combination of 3Mix (combination of metronidazole, minocycline, and ciprofloxacin ) and Simvastatin, as a pulpotomy material. This combination, 3Mixtatin, will be applied with the aim of suppressing bacteria, preventing the pulp inflammation and inducing hard tissue formation. After local anesthesia, isolation and removing caries, following removal of the coronal pulp and hemostasis, the pulp stumps will be covered with 3Mixtatin in group B and Mineral trioxide aggregate ( MTA) in group C. In the control group, FC will be placed with a cotton pellet over the pulp stumps for 5 minutes and removed. The pulp stumps will then be covered by reinforcezinc oxide eugenol (ZOE) paste. All of the treated teeth will subsequently be restored with amalgam and radiography will be taken. The teeth will be followed up 3 months after treatment. In follow up appointment, teeth will be evaluated radiographically and clinically with two examiners who are blind to the experiment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138902203893N2
Registration date: 2016-05-29, 1395/03/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-29, 1395/03/09
Registrant information
Name
Naser Aasl Aminabadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
n-aminabadi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-09-06, 1393/06/15
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the success rate of applying formocresol, 3Mixtatin and Mineral trioxide aggregatein pulpotomy of primary molars
Public title
Comparative evaluation of the success rate of applying formocresol, 3Mixtatin and Mineral trioxide aggregatein pulpotomy of primary molars
Purpose
Treatment
Inclusion/Exclusion criteria
Procedure, possible risks, as well as possible benefits will be thoroughly explained to the parents of the patients aged 3-6 years old and a written informed consent will be taken. Teeth have to had appropriate clinical and radiographic sign and symptoms: 1. Caries primary molars with vital pulp 2. No history of spontaneous 3. No swelling (of pulpal origin) 4. No fistula 5. No pathological tooth mobility 6. No pathologic external root resorption 7. No pathological internal root resorption 8. No periapical or interradicular radiolucency 9. No pulp calcifications 10. No excessive bleeding from the amputated radicular stumps. 11. No history of nocturnal pain 12. No tenderness to percussion or palpation 13. Normal gingival and periodontal condition 14. Absence of periapical or furcal radiolucencies 15. Complete physical and mental health 16. Available to be restored by amalgam or SSC 17. Availability for 3 months follow up
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz Institutional Review Board
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.TBZMED.REC.1395.47

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
Dental hard tissue formation
Timepoint
Before and 3 months after intervention
Method of measurement
Radiography

Secondary outcomes

1

Description
Pain
Timepoint
Before and 3 months after intervention
Method of measurement
Question and palpation

2

Description
Mobility
Timepoint
Before and 3 months after intervention
Method of measurement
Palpation

3

Description
Bone radiographic repair
Timepoint
Before and 3 months after intervention
Method of measurement
Radiography

Intervention groups

1

Description
in Formocresol group , Following the removal of caries and exposure of the pulp, the coronal pulp tissue was removed.A sterile cotton pellet soaked in sterile saline, after cotton pellet soaked in formocresol was placed on the remaining pulp tissue.The cotton pellet was removed from the cavity, a layer of reinforced-zinc oxide eugenol was then placed on the root pulp and the tooth was restored with amalgam
Category
Treatment - Drugs

2

Description
in 3Mixtatin group, Following the removal of caries and exposure of the pulp, the coronal pulp tissue was removed.A sterile cotton pellet soaked in sterile saline. The cotton pellet was removed from the cavity, a layer of 3mixtatin( were mixed with normal saline) was then placed on the root pulp and the tooth was restored with amalgam.
Category
Treatment - Drugs

3

Description
in Mineral trioxide aggregate group (MTA), Following the removal of caries and exposure of the pulp, the coronal pulp tissue was removed.A sterile cotton pellet soaked in sterile saline. The cotton pellet was removed from the cavity, a layer of MTA was then placed on the root pulp and the tooth was restored with amalgam.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Dr. Vajihe Alavi
Street address
Department of Pediatric Dentisry, Tabria Faculty of Dentistry
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz Faculty of Dentistry
Full name of responsible person
Dr. Samiei
Street address
Dean for Research, Tabriz Faculty of Dentistry
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz Faculty of Dentistry
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz Faculty of Dentistry
Full name of responsible person
Dr. Vajihe Alavi
Position
Postgraduate Student
Other areas of specialty/work
Street address
Tabriz Faculty of Dentistry
City
Tabriz
Postal code
Phone
+98 41 3440 5872
Fax
Email
vajihehalavi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz Faculty of Dentistry
Full name of responsible person
Dr. Naser Aminabadi
Position
Professor
Other areas of specialty/work
Street address
Tabriz Faculty of Dentistry
City
Tabriz
Postal code
Phone
+98 41 3334 0310
Fax
Email
aslaminabadi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz Faculty of Dentistry
Full name of responsible person
Dr. Vajihe Alavi
Position
Postgraduate Student
Other areas of specialty/work
Street address
Tabriz Faculty of Dentistry
City
Tabriz
Postal code
Phone
+98 41 3440 5872
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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