|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
IRCT |
|
Last refreshed on:
|
22 February 2018 |
|
Main ID: |
IRCT2017102033162N3 |
|
Date of registration:
|
2017-11-06 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Bioactive Glass and Calcium-Enriched Mixture for Pulp Capping of Primary Teeth
|
|
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 |
|
Date of first enrolment:
|
2016-07-15 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Complete |
|
URL:
|
http://en.irct.ir/trial/25663 |
|
Study type:
|
interventional |
|
Study design:
|
Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Random table number used for randomization.
|
|
Phase:
|
2
|
|
|
Countries of recruitment
|
|
Iran (Islamic Republic of)
| | | | | | | |
|
Contacts
|
|
Name:
|
Farid Abbasi
|
|
Address:
|
N71, Italia Str, Vesal Ave
Tehran
Iran (Islamic Republic of) |
|
Telephone:
|
+98 21 8895 8665 |
|
Email:
|
abassi110@yahoo.com |
|
Affiliation:
|
Shahed University |
|
|
Name:
|
Roghieh Hojjati
|
|
Address:
|
N71, Italia Str, Vesal Ave
Tehran
Iran (Islamic Republic of) |
|
Telephone:
|
+98 21 8895 8665 |
|
Email:
|
hojjati@yahoo.com |
|
Affiliation:
|
Shahed University |
| |
|
Key inclusion & exclusion criteria
|
Inclusion 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
Exclusion criteria:
Age minimum:
7 years
Age maximum:
8 years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
pulpal histology.
|
|
Intervention(s)
|
|
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.
|
|
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..
|
|
Treatment - Drugs
|
|
Primary Outcome(s)
|
|
Pulpal inflamation, HTB. Timepoint: 2 months. Method of measurement: Microscope.
|
|
Secondary Outcome(s)
|
|
Pulpal inflamation, HTB. Timepoint: 2 months. Method of measurement: microscope.
|
|
Source(s) of Monetary Support
|
|
Vice Chancellor for research of Shahed University of Medical Sciences
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Ethics committee of Shahed University
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|