Comparison of the effect of 3Mixtatin and MTA (Mineral Trioxide Aggregate)in direct pulp capping of primary molar teeth.A Randomized controlled clinical Trial
the aim of this study is to compare clinical and radiographic success rates of direct pulp capping (DPC) in primary molars teeth using Mineral Aggregate trioxide(MTA) and a mixture of Simvastatin with three antibiotics (3mixtatin) as a novel endodontic biomaterial.This randomized controlled clinical trial carried on 53 children 4-9 years old that had at least one deep decayed primary molars teeth and the teeth had no spontaneous pain, swelling , fistula, sinus tract, sensitivity to percussion and palpation. The patient did not have systemic diseases. Every tooth, after local anesthesia, was isolated with rubber dam and caries was removed. The bleeding of pin point exposure was controlled and one of two materials was randomly applied on the pin point, then the tooth restored with amalgam. The patients were recalled every 2,6 and 12 months to evaluate clinical and radiographic success.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042121891N1
Registration date:2015-06-16, 1394/03/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-16, 1394/03/26
Registrant information
Name
Ebrahim Najafpour
Name of organization / entity
Faculty of Dentistry, Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5965
Email address
najafpoure@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Science
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-10-21, 1393/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of 3Mixtatin and MTA (Mineral Trioxide Aggregate)in direct pulp capping of primary molar teeth.A Randomized controlled clinical Trial
Public title
Comparison of antibiotic regimens in repair of primary caries in
molar teeth.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Complete physical and mental health without any confounding medical history; Teeth deemed restorable with amalgam; No pathology of the succedaneous permanent teeth follicles; Clinical and Radiographic normal conditions.
Age
From 4 years old to 9 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Committe for Ethics in Research on Humans at Tabriz University of Medical Science
Street address
Tabriz University of Medical Science, Golgasht Ave, Tabriz
City
Tabriz
Postal code
Approval date
2015-06-13, 1394/03/23
Ethics committee reference number
TBZMED.REC.1394.209
Health conditions studied
1
Description of health condition studied
Primary tooth pulp exposure
ICD-10 code
K04
ICD-10 code description
Diseases of pulp and periapical tissues
Primary outcomes
1
Description
pain
Timepoint
before and after intervation.
Method of measurement
clinical examination
2
Description
tenderness to percussion
Timepoint
before and after intervation.
Method of measurement
clinical examination
3
Description
mobility
Timepoint
before and after intervation.
Method of measurement
clinical examination
4
Description
radiolucency
Timepoint
before and after intervation.
Method of measurement
radiographic examination
5
Description
internal resorption
Timepoint
before and after intervation.
Method of measurement
radiographic examination
Secondary outcomes
empty
Intervention groups
1
Description
test :applying 3mixtatin(3 antibiotics with Simvastatin)
Category
Treatment - Drugs
2
Description
control :applying MTA
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Science
Full name of responsible person
Dr Soheil Satrab
Street address
Faculty of Dentistry, Tabriz University of Medical Science, Golgasht Ave, Tabriz, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Dr Naser Asl Aminabadi
Street address
Faculty of Dentistry, Tabriz University of Medical Science, Golgasht Ave, Tabriz, Iran
City
Tabriz
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 Science
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
Faculty of Dentistry, Tabriz University of Medical Science
Full name of responsible person
Dr Ebrahim Najafpour
Position
DDS, Assistant Professor
Other areas of specialty/work
Street address
Faculty of Dentistry, Tabriz University of Medical Science, Golgasht Ave, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3328 4368
Fax
Email
najafpour_e@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry, Tabriz University of Medical Science
Full name of responsible person
Dr Naser Asl Aminabadi
Position
DDS, MSc, Professor
Other areas of specialty/work
Street address
Faculty of Dentistry, Tabriz University of Medical Science, Golgasht Ave, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3335 5965
Fax
Email
aslaminabadi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Dentistry, Tabriz University of Medical Science
Full name of responsible person
Dr Soheil Satrab
Position
DDS, Postgraduate student
Other areas of specialty/work
Street address
Faculty of Dentistry, Tabriz University of Medical Science, Golgasht Ave, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3328 4368
Fax
Email
satdent@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)