Aims: The aim of this study is to evaluate pulpal response of primary teeth after direct pulp capping with two biocompatible materials, Calcium-Enriched Mixture and Bioactive Glass.Design: This study is done as randomized double blind. Setting , conduct: pulpotomy for 20 sound primary canines scheduled for orthodontic extraction. Participants including major eligibility criteria: Inclusion criteria: primary canines in children that had been scheduled for extraction due to their orthodontic treatment plan
Exclusion criteria: root resorption more than the apical third, systemic complications, taking medications, spontaneous toothache and uncooperative children. Intervention: After mechanical pulp exposure, the exposed site is capped with either CEM cement or BAG randomly using a coin and then restored with amalgam.The samples are not informed about design of the study. The teeth are extracted after two months and examined histo- pathologicallyby a pathologist who is not informed about 2 groups.Blinding is done for participants and analizer person. main outcome measures: Parameters of hard tissue bridge (HTB) formation, its type and quality as well as pulpal inflammation scores were compared between the two groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102033162N3
Registration date:2017-11-06, 1396/08/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-06, 1396/08/15
Registrant information
Name
Roza Haghgoo
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 6227
Email address
r.haghgo@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center of Dental School of Shahed University
Expected recruitment start date
2016-07-15, 1395/04/25
Expected recruitment end date
2017-09-10, 1396/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of Bioactive Glass and Calcium-Enriched Mixture for Pulp Capping of Primary Teeth of children who referred to dental clinic
Public title
Bioactive Glass and Calcium-Enriched Mixture for Pulp Capping of Primary Teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: primary canines in children that had been scheduled for extraction due to their orthodontic treatment plan
Exclusion criteria: root resorption more than the apical third, systemic complications, taking medications, spontaneous toothache and uncooperative children
Age
From 7 years old to 8 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random table number used for randomization.
Secondary Ids
1
Registry name
ـ
Secondary trial Id
ـ
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
N4, Kargar Str, Enghelab Sq
City
Tehran
Postal code
Approval date
2015-12-20, 1394/09/29
Ethics committee reference number
41/357530
Health conditions studied
1
Description of health condition studied
pulpal histology
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pulpal inflamation, HTB
Timepoint
2 months
Method of measurement
Microscope
Secondary outcomes
1
Description
pulpal inflamation, HTB
Timepoint
2 months
Method of measurement
microscope
Intervention groups
1
Description
20 sound primary canines scheduled for orthodontic extraction, were selected. After mechanical pulp exposure, the exposed site was capped with either CEM cement or BAG and then restored with amalgam. The teeth were extracted after two months and examined histo- pathologically. Parameters of hard tissue bridge (HTB) formation, its type and quality as well as pulpal inflammation scores were compared between the two groups. The data were analyzed using Fisher’s exact test.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School of Shahed University
Full name of responsible person
Roghieh Hojjati
Street address
N 71- Italia Str- Vesal Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahed University of Medical Sciences
Full name of responsible person
Roghieh Hojjati
Street address
N71, Italia Str, Vesal Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahed 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
Shahed University
Full name of responsible person
Roghieh Hojjati
Position
PHD
Other areas of specialty/work
Street address
N71, Italia Str, Vesal Ave
City
Tehran
Postal code
Phone
+98 21 8895 8665
Fax
Email
hojjati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Farid Abbasi
Position
Oral Medicine
Other areas of specialty/work
Street address
N71, Italia Str, Vesal Ave
City
Tehran
Postal code
Phone
+98 21 8895 8665
Fax
Email
abassi110@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental School, Shahed University
Full name of responsible person
Roghieh Hojjati
Position
MA
Other areas of specialty/work
Street address
N71- Italia Str- Vesal Ave
City
Tehran
Postal code
98 21 1417755351
Phone
+98 21 8895 8864
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)