A comparison between conventional puplcap therapy with Mineral Trioxide Aggregate and laser assisted pulpcap therapy with Mineral Trioxide Aggregate in patients older than 10 who needed pulp cappings for deep caries affecting their permanent teeth
This study aims at comparing two techniques of direct pulp capping with MTA alone and by means of Er:YAG laser.
The study is non-randomized and single blinded,controlled with placebo ,related to phase 2-3 of clinical trial
This study will be carried out on permanent teeth of patient older than 10 ,with deep caries but with out any signs of irreversible pulpitis. The teeth must be mature with closed apexes.
Our total number of patients is 28, 14 in each group,by using this formula :
n=(Z1-α/2 + Z1-β)2 (p1(1-p1) +p2(1-p2)) / (p1-p2)2
p1=65% success rate in control group
p2=100% predicted success rate in intervention group
n=14
The study will be carried out on patients who needed pulp cappings for deep caries affecting their permanent teeth. The patients will be devided into two groups :1st group using traditional technique(using MTA) for pulp cap cappings and 2nd group using laser assisted pulp capping ( by means of Er:YAG laser).
Patients will be asked for follow ups after 1 month ,3 months and 6 months. Vitality of the teeth will be checked during the follow up sessions by using vitality tests and x-ray radiography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102015078N1
Registration date:2013-11-22, 1392/09/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-22, 1392/09/01
Registrant information
Name
Hamid Kermanshah
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21888445534
Email address
kermansh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-11-06, 1392/08/15
Expected recruitment end date
2014-01-05, 1392/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between conventional puplcap therapy with Mineral Trioxide Aggregate and laser assisted pulpcap therapy with Mineral Trioxide Aggregate in patients older than 10 who needed pulp cappings for deep caries affecting their permanent teeth
Public title
Laser-assisted Pulp Capping
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:patients older than 10 ; teeth with deep caries with less than 1 mm distance to pulp
exclusion criteria:any signs of irreversible pulpitis;bruxism ; history of chemotherapy or radiotherapy
Age
From 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Studies of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2013-04-21, 1392/02/01
Ethics committee reference number
91-04-97-19119-81711
Health conditions studied
1
Description of health condition studied
exposed pulps
ICD-10 code
K02.8
ICD-10 code description
Other dental caries
Primary outcomes
1
Description
pulp vitality
Timepoint
1 month 3 month 6 month
Method of measurement
clinical vitality tests
Secondary outcomes
empty
Intervention groups
1
Description
using Er:YAG laser (wavelength=2940nm, long pulse. frequency= 10 Hz ,contact mode)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences , Dental Faculty
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research , Tehran University of Medical Sciences
Full name of responsible person
dr Yunesian
Street address
Central Organization of Tehran University of Medical Sciences , Keshavarz St.
City
Tehran
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 , Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Niloufar Daneshparvar
Position
dental student
Other areas of specialty/work
Street address
Dental Facuty of Tehran University of Medical Sciences , North Amirabad St.
City
Tehran
Postal code
Phone
+212 2765236
Fax
Email
nildan89@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Kermanshah
Position
Assisted Professor
Other areas of specialty/work
Street address
Dental Faculty of Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+218 8844553
Fax
Email
kermanshahhamid@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Niloufar Daneshparvar
Position
student
Other areas of specialty/work
Street address
Dental Facuty of Tehran University of Medical Sciences , North Amirabad St.
City
Postal code
Phone
Fax
Email
nildan89@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)