Effect of Direct Pulp Capping with Propolis and Calcium Hydroxide versus Mineral Trioxide Aggregate on Formation of Dentin Bridge in patents who are candidate for extraction of the third molar: a double blinded randomized clinical trial
Objectives: To assess the effect of direct pulp capping with propolis, calcium hydroxide and mineral trioxide aggregate on formation of dentin bridge.
Design: a double blinded randomized clinical trial.
Setting and conduct: All eligible patients who are candidate for extraction of the third molar and will refer to the maxillofacial surgery ward of School of Dentistry of Hamadan during the study period will be enrolled.
Inclusion criteria: (a) candidate for extraction of the third molar; (b) age of 20 to 30 years.
Exclusion criteria: (a) presence of and dental caries in the third molar; (b) history of trauma to the third molar; (c) presence of lesion in periapical or periodontal area.
Intervention: Direct pulp capping of the third molar with propolis at 3 to 3.5 mm in depth, 4 to 4.5 mm width mesiodistally, and 3 to 3.5 mm width buccolingually.
Control: (a) Direct pulp capping of the third molar with calcium hydroxide at 3 to 3.5 mm in depth, 4 to 4.5 mm width mesiodistally, and 3 to 3.5 mm width buccolingually; (b) Direct pulp capping of the third molar with mineral trioxide aggregate at 3 to 3.5 mm in depth, 4 to 4.5 mm width mesiodistally, and 3 to 3.5 mm width buccolingually.
Primary outcome: Formation of dentin bridge through assessing the third molar histologically 45 days after intervention.
Secondary outcome: (a) presence of inflammation through assessing the third molar pulp histologically 45 days after intervention; (b) quality of the dentin bridge through assessing the third molar histologically 45 days after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403049014N30
Registration date:2014-03-11, 1392/12/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-03-11, 1392/12/20
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-04-09, 1393/01/20
Expected recruitment end date
2014-04-30, 1393/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Direct Pulp Capping with Propolis and Calcium Hydroxide versus Mineral Trioxide Aggregate on Formation of Dentin Bridge in patents who are candidate for extraction of the third molar: a double blinded randomized clinical trial
Public title
Effect of Direct Pulp Capping with Propolis and Calcium Hydroxide versus Mineral Trioxide Aggregate on Formation of Dentin Bridge in patents who are candidate for extraction of the third molar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) candidate for extraction of the third molar; (b) age of 20 to 30 years.
Exclusion criteria: (a) presence of and dental caries in the third molar; (b) history of trauma to the third molar; (c) presence of lesion in periapical or periodontal area.
Age
From 20 years old to 30 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control group systematically one at a time.
Blinding: The three drugs will be prescribed during pulp capping thus the patients will not aware of the intervention. In addition, the pathologist, who will assess the formation of the dentin bridge, will not aware of the intervention. Therefore, the trial will be run double blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-03-02, 1392/12/11
Ethics committee reference number
D/P/16/35/9/4196
Health conditions studied
1
Description of health condition studied
Formation of dentin bridge
ICD-10 code
K04.3
ICD-10 code description
Abnormal hard tissue formation in pulp
Primary outcomes
1
Description
Formation of dentin bridge
Timepoint
45 days after intervention
Method of measurement
through assessing the third molar histologically
Secondary outcomes
1
Description
presence of inflammation
Timepoint
45 days after intervention
Method of measurement
through assessing the third molar pulp histologically
2
Description
quality of the dentin bridge
Timepoint
45 days after intervention
Method of measurement
through assessing the third molar histologically
Intervention groups
1
Description
Direct pulp capping of the third molar with propolis at 3 to 3.5 mm in depth, 4 to 4.5 mm width mesiodistally, and 3 to 3.5 mm width buccolingually
Category
Treatment - Drugs
2
Description
Direct pulp capping of the third molar with calcium hydroxide at 3 to 3.5 mm in depth, 4 to 4.5 mm width mesiodistally, and 3 to 3.5 mm width buccolingually
Category
Treatment - Other
3
Description
Direct pulp capping of the third molar with mineral trioxide aggregate at 3 to 3.5 mm in depth, 4 to 4.5 mm width mesiodistally, and 3 to 3.5 mm width buccolingually
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Dr Golsa Salehi Mehr
Street address
School of Dentistry, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
School of Dentistry
Full name of responsible person
Dr Golsa Salehi Mehr
Position
Resident of Endodontic
Other areas of specialty/work
Street address
School of Dentistry, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 1838 1086
Fax
Email
g.salehi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Dr Shahriar Shahriari
Position
Endodontist
Other areas of specialty/work
Street address
School of Dentistry, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 1838 1086
Fax
Email
shahriari1390@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)