Histological study of Ca(OH)2 effect and different concentrations of SIMVASTATIN on pulp-dentin complex response after Direct Pulp Capping .
on primary molars of 7-9 years old children who had serial extraction treatment plan, hard tissue formation was evaluated.
Aim: The aim of present study was to investigate pulp-dentin complex reactions following direct pulp capping (DPC) with calcium hydroxide [Ca(OH)2] and simvastatin as pulp-capping materials in the primary human molars.
study procedure:
Randomized, double blind, single study.
72 primary molar teeth which had to be extracted for orthodontic reasons were randomly allocated into four groups. Group Ι as a control, underwent DPC with calcium hydroxide. The dental pulp in group ІІ, ІІІ and ІV were directly capped with simvastatin-based materials at concentrations of 1, 5 and 10 µM/L, respectively. All of the teeth were restored with stainless steel crown. After a mean period of 7.41 months (6-9 months) teeth were extracted and processed for histological examination and categorized in terms of hard tissue formation and pulp inflammation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012071410276N1
Registration date:2012-09-16, 1391/06/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-16, 1391/06/26
Registrant information
Name
Ensiyeh Maljaei
Name of organization / entity
Dental Faculty of Tabriz Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
joddd@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Dr. Mohammad reza Rashidi
Expected recruitment start date
2011-07-20, 1390/04/29
Expected recruitment end date
2011-10-29, 1390/08/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Histological study of Ca(OH)2 effect and different concentrations of SIMVASTATIN on pulp-dentin complex response after Direct Pulp Capping .
on primary molars of 7-9 years old children who had serial extraction treatment plan, hard tissue formation was evaluated.
Public title
Histological study of Ca(OH)2 effect and different concentrations of SIMVASTATIN on pulp-dentin complex response after Direct Pulp Capping
Purpose
Treatment
Inclusion/Exclusion criteria
Cases were selected considering the following inclusion criteria:
1.primary first and second molars.
2.deep caries but no indication for pulpotomy or pulp therapy.
3.teeth which had to be extracted to orthodontic treatment plan in close future but also had tobe treated due to deep caries.
4.patient willfulness.
Exclusion criteria:
1. Teeth in which there is inflammation at the exposure site, or bleeding in an amount for a hyperemic or inflamed pulp
2. Necrotic or infectious pulps
3. Carious exposures.
Age
From 7 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Ethics Committee
Street address
Central building No.2- Tabriz University of Medical Sciences- University avenue
City
Tabriz
Postal code
5165665931
Approval date
2012-07-09, 1391/04/19
Ethics committee reference number
9162
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Hard tissue formation
Timepoint
After 6-9 months as part of the orthodontic treatment
Method of measurement
Microscopic view
Secondary outcomes
1
Description
Pulp inflammaetion
Timepoint
After 6-9 months as part of the orthodontic treatment
Method of measurement
Microscopic view
Intervention groups
1
Description
Control group: Direct pulp capping by calcium hydroxide for 6-9 months.
Direct pulp capping (DPC) involves the application of a medicament, dressing or dental material on the exposed pulp in an attempt to preserve its vitality
Category
Rehabilitation
2
Description
Intervention group (2): Direct pulp capping by 1 µM/L simvastatin for 6-9 months.
Direct pulp capping (DPC) involves the application of a medicament, dressing or dental material on the exposed pulp in an
Category
Rehabilitation
3
Description
Intervention group (3): Direct pulp capping by 5 µM/L simvastatin for 6-9 months .
Direct pulp capping (DPC) involves the application of a medicament, dressing or dental material on the exposed pulp in an
Category
Rehabilitation
4
Description
Intervention group (4): Direct pulp capping by 10 µM/L simvastatin for 6-9 months.
Direct pulp capping (DPC) involves the application of a medicament, dressing or dental material on the exposed pulp in an
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental faculty, Tabriz University of Medical Sciences
Full name of responsible person
Ensiyeh Maljaei
Street address
Department of pediatric dentistry- faculty of dentistry- Daneshgah Avenue
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. mohammadreza rashidi
Street address
Central building no 2 - Tabriz university - University avenue
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Naser Asl Aminabadi
Position
Pedodontist/professor
Other areas of specialty/work
Street address
Faculty of Dentistry- Daneshgah avenue
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
n-aminabadi@tbzmed.ac.ir
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
Pedodontist / professor
Other areas of specialty/work
Street address
Faculty of dentistry - Daneshgah Avenue
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
n-aminabadi@tbzmed.ac.ir; 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
Ensiyeh Maljaei
Position
Post graduate student
Other areas of specialty/work
Street address
Faculty of Dentistry - Daneshgah Avenue
City
Tabriz
Postal code
5165665931
Phone
+98 41 1335 5965
Fax
Email
e_maljaei@yahoo.com; joddd@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)