The aim of the present study was to assess the effect of a combination of three antibiotics and simvastatin (3Mixtatin) on the repair in hopeless primary molars. In this randomized clinical trial, 80 teeth from 65 healthy children aged 3–6 years with interradicular or periapical root resorption and/or perforation in primary molars were treated with either 3Mixtatin or MTA before restoration. The subjects were followed up clinically and radiographically 4, 6 and 12 months after pulp treatment to evaluate and compare the healing process. The data were compared using chi-square test at a significance level of 0.05. At the end of 12 months in 3Mixtatin group, 32 (96.9%) teeth revealed no clinical signs or symptoms with arrested resorption progress radiographically. In MTA group, clinical signs and symptoms including pain, mobility and sinus tract were seen in 18 (47.3%) teeth with cessation of root/interradicular radiolucency in 8 (21.0%) teeth but no bone repair. Healing with no inflammation and hard tissue formation occurred more successfully following 3Mixtatin treatment compared with treatment with MTA. This finding can have direct implications for preservation of hopeless primary teeth with perforation or root resorption.
General information
Acronym
MTA : mineral trioxide aggregate
3mixtatin : 3mix + simvastatin
3mix: A combination of metronid
IRCT registration information
IRCT registration number:IRCT2013071714031N1
Registration date:2013-10-14, 1392/07/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-14, 1392/07/22
Registrant information
Name
Sepideh Agheli
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5963
Email address
3pideh.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-10-19, 1391/07/28
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 3Mixtatin to preserve primary teeth: a randomized clinical trial
Public title
Comparison of antibiotic regimens in repair of primary molars of 3 to 6 years old children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
•Complete physical and mental health without any confounding medical history.
•Teeth deemed restorable with a stainless steel crown, amalgam or composite restoration.
•No pathology of the succedaneous permanent teeth follicles.
•Interradicular perforation and/or root resorption in 1/3 coronal of root with adequate bone support.
Age
From 3 years old to 6 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
Tabriz University of Medical Sciences
Street address
Tabriz Dental Faculty, Golgasht St.
City
Tabriz
Postal code
Approval date
2012-09-17, 1391/06/27
Ethics committee reference number
9272
Health conditions studied
1
Description of health condition studied
Perforation and resorption
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Perforation and resorption
Timepoint
Before and after dental intervention
Method of measurement
Radiographical and clinical symptoms
Secondary outcomes
empty
Intervention groups
1
Description
3mixtatin
Category
Treatment - Drugs
2
Description
control: applying MTA
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Dental Faculty
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Naser Asl Aminabadi
Street address
Tabriz University of Medical Sciences
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 Sciences
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
Department Of Pediatric Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Dr Naser Asl Aminabadi
Position
DDS, MSc, professor
Other areas of specialty/work
Street address
Tabriz Dental Faculty, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
aslaminabadi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Naser Asl Aminabadi
Position
DDS, MSc, professor
Other areas of specialty/work
Street address
Tabriz Dental Faculty, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
aslaminabadi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Sepideh Agheli
Position
DDS, Postgraduate student
Other areas of specialty/work
Street address
Department Of Pediatric Dentistry, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
Fax
Email
3pideh.a@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)