Histologic response of human dental pulp to dexamethasone treatment following MTA-direct pulp capping and MTA-partial pulpotomy: A randomized clinical trial
The aim of this randomized clinical trial was to histologically investigate the possible effects of dexamethasone application after MTA- DPC and PP in human premolar teeth.
Methods and Materials: Forty intact premolar teeth will select from 10 healthy orthodontic patients that will candidates for extraction of four premolars; the teeth will randomize for DPC (n=20) or PP (n=20). After anesthesia and isolation, a class I cavity will prepare and buccal pulp horn will expose using a high speed ½ round high speed bur under copious water coolant. The buccal pulp horn exposure will pinpoint in size for DPC group, while whole head of the bur will enter into the pulpal horn in PP group. Subsequently, exposure site will seal using ProRoot MTA and cavities will restore with glass ionomer. After 60 days, the teeth will extract and 4 micron sections will prepare. Histologic evaluation will performe by an independent oral and maxillofacial pathologist. Kruskal-Wallis and Fisher exact tests will use for statistical analysis of the data (P=0.05).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080618711N1
Registration date:2014-08-22, 1393/05/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-22, 1393/05/31
Registrant information
Name
Seyed Amir Mousavi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3673 6517
Email address
mousavi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-08-20, 1393/05/29
Expected recruitment end date
2014-09-20, 1393/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Histologic response of human dental pulp to dexamethasone treatment following MTA-direct pulp capping and MTA-partial pulpotomy: A randomized clinical trial
Public title
effect of dexamethasone on dental pulp
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The teeth must have no history of trauma; absence of caries; restorations; periodontal problems;
Exclusion criteria: Patients with known allergy; sensitivity; contraindications for use of dexamethasone
Age
No age limit
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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Bolvar vakil abad
City
Mashhad
Postal code
Approval date
2012-10-27, 1391/08/06
Ethics committee reference number
910281
Health conditions studied
1
Description of health condition studied
pulpitis
ICD-10 code
K04
ICD-10 code description
Diseases of pulp and periapical tissues
Primary outcomes
1
Description
calcified bridge
Timepoint
2 months
Method of measurement
h and e staining
Secondary outcomes
1
Description
tissue reaction
Timepoint
2 months
Method of measurement
microscope
Intervention groups
1
Description
Forty intact premolar teeth will select from 10 healthy orthodontic patients that will candidates for extraction of four premolars; the teeth will randomiz for DPC (n=20) or PP (n=20). After anesthesia and isolation, a class I cavity was prepared and buccal pulp horn will expose using a high speed ½ round high speed bur under copious water coolant. The buccal pulp horn exposure will pinpoint in size for DPC group, while whole head of the bur will enter into the pulpal horn in PP group. The half of the DPC or PP groups, will receive dexamethasone in "solution" . Subsequently, exposure site was sealed using ProRoot MTA and cavities will restore with glass ionomer. After 60 days, the teeth were extracted and 4 micron sections prepared. Histologic evaluation will performe by an independent oral and maxillofacial pathologist.
Category
Treatment - Drugs
2
Description
for group 1: The buccal pulp horn exposure will pinpoint in size for DPC group
Category
Treatment - Drugs
3
Description
for group 2: whole head of the bur will enter into the pulpal horn in PP group
Category
Treatment - Drugs
4
Description
for goup 3:The half of the DPC group, will receive dexamethasone in "solution"
Category
Treatment - Drugs
5
Description
for group 4:The half PP group , will receive dexamethasone in "solution"
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Research Center of Mashhad University of Medical Sciences
Full name of responsible person
Seyed Amir Mousavi
Street address
Number 1 ; Koye Emamsadegh ; Isfahan ; Iran
City
isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Jamileh Ghoddusi
Street address
Iran , Mashhad , Vakilabad bolvar , Dental Reasearch Center
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr Seyed Amir Mousavi
Position
Assistant perofessor
Other areas of specialty/work
Street address
Number 1 , Koye emamsadegh , Isfahan , Iran
City
Isfahan
Postal code
8174663651
Phone
+98 31 3673 6517
Fax
Email
mousavi@dnt.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Seyed Amir Mousavi
Position
Endodontist,assistant professor
Other areas of specialty/work
Street address
Number 1 , Koye emamsadegh , Isfahan , Iran
City
Isfahan
Postal code
8174663651
Phone
+98 31 3673 6517
Fax
Email
mousavi@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Seyed Amir Mousavi
Position
Assistant professor
Other areas of specialty/work
Street address
Number 1 , Koye emamsadegh , Isfahan , Iran
City
Isfahan
Postal code
8174663651
Phone
+98 31 3673 6517
Fax
Email
mousavi@dnt.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)