Protocol summary

Summary
The aim of present study sought to histologically assess and compare pulp tissue following pulp capping with propolis and Dycal A cavity was prepared in the center of the occlusal surface of 10 human third molars that no traumatic, carious, periapical or periodontal lesions existed using a cylindrical bur. The pulp was exposed with a round bur. Samples were randomly divided into two groups. The first group underwent direct pulp capping with propolis and the second group with Dycal. Autopolymerizing glass ionomer was then applied to seal the area. The teeth were extracted after 45 days and histologically evaluated. presence of inflammation, its severity, formation of dentinal bridge and its quality and quantity and presence of odontoblast-like cells were assessed

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013031712832N1
Registration date: 2013-06-09, 1392/03/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-06-09, 1392/03/19
Registrant information
Name
Zohreh Ahangari
Name of organization / entity
Dental school shahid Beheshti Medical university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 4094
Email address
zohrehahangari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2013-05-01, 1392/02/11
Expected recruitment end date
2013-11-01, 1392/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Histological Evaluation of Pulp Tissue Following Direct Pulp Capping with Propolis and Dycal
Public title
Propolis effect on dental pulp
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Vital third molars Exclusion criteria: Previous trauma; carious lesion; periapical lesions; periodontal lesions
Age
From 20 years old to 28 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research of Dental School of Shahid Beheshti University of Medical Sciences
Street address
Daneshjoo Blvd، Evin
City
Tehran
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
-

Health conditions studied

1

Description of health condition studied
Dental carries and Pulp involvment
ICD-10 code
K02.8
ICD-10 code description
K02.8 Other dental caries

2

Description of health condition studied
Dental carries and Pulp involvment
ICD-10 code
K04.3
ICD-10 code description
Abnormal hard tissue formation in pulp

Primary outcomes

1

Description
Direct pulp cap
Timepoint
45
Method of measurement
Histologic Evaluation

Secondary outcomes

1

Description
Severity of inflammation
Timepoint
After 45 days
Method of measurement
Histologic Evaluation

2

Description
Quality of newly formed dentin, Quantity of the newly formed dentin,
Timepoint
After 45 days
Method of measurement
Histologic Evaluation

3

Description
Presence of odontoblast-like cells
Timepoint
After 45 days
Method of measurement
Histologic Evaluation

Intervention groups

1

Description
The teeth were disinfected Local anesthesia was induced, rubber dam was placed and an occlusal cavity was prepared using a sterile cylindrical diamond bur and high speed hand piece with air-water spray as the coolant. The prepared cavity measured 3-3.5 mm in depth, 4-4.5 mm in mesiodistal width and 3-3.5 mm in buccolingual width. The mentioned measurements were done using a periodontal probe. Pulp chamber was exposed at the center of the pulp chamber roof using a round diamond bur with air-water spray. Hemostasis was achieved by mild pressure of a moist cotton ball at the exposure site. The exposure site was then completely dried with a dry cotton ball. This procedure was repeated until achieving complete hemostasis. If hemostasis was not achieved after 5 minutes of using a cotton ball, the sample was excluded from the study. The teeth were divided into two groups of 5 samples each. The exposure site in group one was covered with Dycal ( control groups)
Category
Treatment - Drugs

2

Description
The teeth were disinfected . Local anesthesia was induced, rubber dam was placed and an occlusal cavity was prepared using a sterile cylindrical diamond bur and high speed hand piece with air-water spray as the coolant. The prepared cavity measured 3-3.5 mm in depth, 4-4.5 mm in mesiodistal width and 3-3.5 mm in buccolingual width. The mentioned measurements were done using a periodontal probe. Pulp chamber was exposed at the center of the pulp chamber roof using a round diamond bur with air-water spray. Hemostasis was achieved by mild pressure of a moist cotton ball at the exposure site. The exposure site was then completely dried with a dry cotton ball. This procedure was repeated until achieving complete hemostasis. If hemostasis was not achieved after 5 minutes of using a cotton ball, the sample was excluded from the study. The teeth were divided into two groups of 5 samples each in group two with propolis(experimental groups).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endodontic Dept. of Dental school of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr zohreh ahangari
Street address
Daneshjoo Blvd، Evin
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dental school of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr maryam moezizadeh
Street address
Daneshjoo Blvd، Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental school of Shahid Beheshti 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
Dental school of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Zohreh Ahangari
Position
Associate Professor، Endodontist
Other areas of specialty/work
Street address
Daneshjoo Blvd. Evin
City
Tehran
Postal code
198396313
Phone
+98 21 2990 2305
Fax
+98 21 2241 2507
Email
zohrehahangari@sbmu.ac.irzohrehahangari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental school of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Zohreh Ahangari
Position
Endodontist ,Associate Professor
Other areas of specialty/work
Street address
Daneshjoo Blvd، Evin
City
Tehran
Postal code
198396313
Phone
+98 21 2990 2305
Fax
+98 21 2241 2507
Email
zohrehahangari@sbmu.ac.irzohrehahangari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti Dental school
Full name of responsible person
Dr Zohreh Ahangari
Position
Associate Professor، Endodontist
Other areas of specialty/work
Street address
Daneshjoo Blvd. Evin
City
Tehran
Postal code
198396313
Phone
+98 21 2990 2305
Fax
+98 21 2241 2507
Email
zohrehahangari@sbmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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