The aim of this randomized clinical trial will comparing the effect of ProRoot MTA and MTA/Treated Dentin Matrix (TDM) on clinical and histologic manifestations of human healthy dental pulp.
Healthy volunteers aged between 18 to 30, male or female with at least 3 intact third molars included in this study.
Twenty human intact third molars will be randomly allocated into two experimental groups (n=10) either treated and capped with ProRoot MTA or MTA/Treated Dentin Matrix subsequent to partial pulpotomy treatment.
Six weeks after treatment, clinical sign/symptoms and radiographic changes will be evaluated. The teeth will then be extracted and examined histologically for inflammatory status of the pulp and dentinal bridge formation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013121415782N1
Registration date:2014-02-16, 1392/11/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-16, 1392/11/27
Registrant information
Name
Peyman Mehrvarzfar
Name of organization / entity
Tehran Medical Science Branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 8875 9644
Email address
p_mehrvarzfar@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University,Tehran Medical Science Branch
Expected recruitment start date
2014-01-20, 1392/10/30
Expected recruitment end date
2014-04-20, 1393/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the effect of ProRoot MTA and MTA/Treated Dentin Matrix (TDM) on clinical and histologic manifestations of human healthy dental pulp
Public title
comparing the effect of two different materials on human dental pulp
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patients between 18 to 30 years old; patients that have at least 3 mature and intact third molars to be extracted; healthy periodontal condition
exclusion criteria: systemic diseases; medication intake
Age
From 18 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍٍEthics Committee of Tehran Medical Science Branch, Islamic Azad University
Street address
No.4, Neyestan1o Ave, Pasdaran street
City
Tehran
Postal code
19585/175
Approval date
2013-10-22, 1392/07/30
Ethics committee reference number
د/214/پ
Health conditions studied
1
Description of health condition studied
Human Pulp Regeneration
ICD-10 code
Y56.7
ICD-10 code description
Dental drugs, topically applied
Primary outcomes
1
Description
clinical signs and symptoms (sensitivity to cold test and percussion)
Timepoint
1,3,7,14,21,28,35 and42 days after partial pulpotomy
Method of measurement
pulp vitality tests including thermal tests,Electric pulp test,pain, percussion, palpation,radiography
2
Description
histologic pulp tissue evaluation including inflamation
Timepoint
day 42 after intervention
Method of measurement
light microscopic evaluation
3
Description
histologic pulp tissue evaluation including dentin bridge formation
Timepoint
day 42 after intervention
Method of measurement
light microscopic evaluation
Secondary outcomes
1
Description
histologic pulp tissue evaluation including pulp necrosis or abcess formation
Timepoint
after extraction(daye 42)
Method of measurement
light microscopic evaluation
Intervention groups
1
Description
intervention: ProRoot MTA/Treated Dentin Matrix in two separate layers of each 1mm thickness, pulpal layer includes TDM and then a layer of MTA covering it, for 6 weeks.
Category
Treatment - Drugs
2
Description
control: ProRoot MTA
that covering the pulpal exposure in one layer of 2mm thickness
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Medical science Branch,Islamic Azad University
Full name of responsible person
Peyman Mehrvarzfar
Street address
No.4, Neyestan10 Alley, Pasdaran Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
self-sponsored by researchers in study
Full name of responsible person
Peyman Mehrvarzfar
Street address
Tehran Medical Science Branch, Islamic Azad University
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
self-sponsored by researchers in study
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
Tehran Medical science Branch, Islamic Azad University
Full name of responsible person
Sohrab Tour Savadkouhi
Position
Endodontic Resident/ DDS
Other areas of specialty/work
Street address
No.4, Neyestan10 Alley, Pasdaran Street
City
Tehran
Postal code
19585/175
Phone
+98 21 2613 0156
Fax
Email
s_savadkouhi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Medical Science Branch, Islamic Azad University
Full name of responsible person
Peyman Mehrvarzfar
Position
Associate Professor/ DDS,Ms
Other areas of specialty/work
Street address
No 4, Neyestan 10 Alley, Pasdaran Street
City
Tehran
Postal code
Phone
+98 21 8875 9644
Fax
Email
P_mehrvarzfar@dentaliau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Medical Science Branch, Islamic Azad University
Full name of responsible person
Sohrab Tour Savadkouhi
Position
Endodontic Resident/ DDs
Other areas of specialty/work
Street address
No.4, Neyestan10 Alley, Pasdaran Street
City
Tehran
Postal code
19585/175
Phone
00
Fax
Email
s_savadkouhi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)