Clinical trial t compare the effect of CEM, MTA and Biodentin on dental pulp's histological response in orthodontic patients undergoing tooth extraction.
The main goal of the study is to compare the histological response of the pulp to three pulp coating materials: Mineral trioxide aggregate (MTA) , Calcium enriched mixture (CEM) and Biodentin.
The design of this study was experimental, randomized, single-blind, control group, placebo-free and single-centered.
Inclusion criteria: human premolars; no fillings; cervical erosion; caries; teeth that are going to be extracted for orthodontic treatment; both gender; 14 - 25 years of age.
Exclusion criteria: previous caries; filling; history of trauma; periodontal disease; severe pain; need to early extraction; unwillingness to cooperate.
Intervention:
All teeth in the patients who are included in the study are randomly assigned to drawn number between 1 to 4, then divided by the number they assigned to the following groups:
group1: Treatment by MTA; group 2: Treatment by CEM; group 3: Treatment by Biodentin; group 4: Control group.
The pulp of the teeth will be exposed and then the substance will be placed on the pulp according to the teeth group and then restoration will be done using RMGI. There will be no process on the control group.
Then teeth will be extracted after 6 weeks and will be cut for pathological tests.
Primary outcomes: necrosis, dentin formation, odontoblast formation, pulp inflammation type, inflammation intensity and pulp inflammation extension.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017091728804N2
Registration date:2017-11-18, 1396/08/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-18, 1396/08/27
Registrant information
Name
Razieh Hosseinifar
Name of organization / entity
Dental School, Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 9021
Email address
r.hosseinifar@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2017-10-22, 1396/07/30
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial t compare the effect of CEM, MTA and Biodentin on dental pulp's histological response in orthodontic patients undergoing tooth extraction.
Public title
Dental pulp histological respond to MTA, CEM and BIODENTIN
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: human premolars; no fillings; cervical erosion; caries; teeth that are going to be extracted for orthodontic treatment; both gender; 14 - 25 years of age. Exclusion criteria: previous caries; filling; history of trauma; periodontal disease; severe pain; need to early extraction; unwillingness to cooperate.
Age
From 14 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
All teeth in the patients who are included in the study are randomly assigned to drawn number between 1 to 4, then divided by the number they assigned to the following groups:
Number 1: Treatment by MTA; Number 2: Treatment by CEM; Number 3: Treatment by BIODENTIN; Number 4: Control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Ebn Sina st. Jahad blvd. Somayed cross section.
City
Kerman
Postal code
Approval date
2017-09-17, 1396/06/26
Ethics committee reference number
IR.KMU.REC.1395.549
Health conditions studied
1
Description of health condition studied
Pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Inflammation type
Timepoint
6 weeks after intervention
Method of measurement
Measurement on pathology slide.
2
Description
Formation of odontoblast cell
Timepoint
6 weeks after intervention
Method of measurement
Measurement on pathology slide.
3
Description
Width of dentin bridge
Timepoint
6 weeks after intervention
Method of measurement
Measurement on pathology slide.
4
Description
Forming dentin bridge
Timepoint
6 weeks after intervention
Method of measurement
Measurement on pathology slide.
5
Description
Necrosis
Timepoint
6 weeks after intervention
Method of measurement
Measurement on pathology slide.
6
Description
Severity of inflammation
Timepoint
6 weeks after intervention
Method of measurement
Measurement on pathology slide.
7
Description
Extent of inflammation
Timepoint
6 weeks after intervention
Method of measurement
Measurement on pathology slide.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Placing Biodontin (Septodent Inc.) on prepared cavity near the pulp of premolar teeth according to manufacturer recommended procedure.
Category
Treatment - Other
2
Description
Intervention group 2: Placing MTA (Angelus Inc.) on prepared cavity near the pulp of premolar teeth according to manufacturer recommended procedure.
Category
Treatment - Other
3
Description
Intervention group 3: Placing CEM (Yektazist dandan Inc.) on prepared cavity near the pulp of premolar teeth according to manufacturer recommended procedure.
Category
Treatment - Other
4
Description
Control group: no procedure is going to be done.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthodontics Division of Kerman Dentistry University.
Full name of responsible person
Dr. Freshteh Safarian.
Street address
Shafa St.
City
Kerman.
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Kerman University of Medical Sciences
Full name of responsible person
Samaneh Rafiee.
Street address
Kosar blvd.
City
Kerman
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 Kerman 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
Operative dentistry division of Kerman Dentistry University.
Full name of responsible person
Elina Rahminian.
Position
Resident of oprative dentistry of kerman dentistry university.
Other areas of specialty/work
Street address
Shafa st.
City
Kerman
Postal code
Phone
+98 34 3211 9021
Fax
Email
elinaa.er@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Operative division of Kerman Dentistry University.
Full name of responsible person
Elina Rahmanian.
Position
Operative dentistry resident of Kerman Dentistry University.
Other areas of specialty/work
Street address
Shafa St.
City
Kerman.
Postal code
Phone
+98 342119021
Fax
Email
elinaa.er@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Operative division of Kerman Dentistry University.
Full name of responsible person
Elina Rahmanian.
Position
Operative dentistry resident of Kerman Dentistry University.
Other areas of specialty/work
Street address
Shafa St.
City
Kerman.
Postal code
Phone
+98 34 3211 9021
Fax
Email
elinaa.er@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)