Aim: to compare clinical and radiographic success rates of direct pulp capping (DPC) in primary molars teeth using Mineral Aggregate trioxide(MTA) and Calcium Enriched Mixture(CEM) cement as a novel endodontic biomaterial. Materials and methods: This triple blind randomized controlled clinical trial carried on 21 children 5-8 years old that had at least 2 deep decayed primary molars teeth and the teeth had no spontaneous pain, swelling , fistula, sinus tract, sensitivity to percussion and palpation. The patient did not have systemic diseases. Every tooth, after local anesthesia, was isolated with cotton roll and caries was removed. The bleeding of pin point exposure was controlled and one of two materials was randomly applied on the pin point, then the tooth restored with amalgam. The patients were recalled every 6 and 12 months to evaluate clinical and radiographic success.
General information
Acronym
DPC
IRCT registration information
IRCT registration number:IRCT138802161882N1
Registration date:2010-05-27, 1389/03/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-27, 1389/03/06
Registrant information
Name
Masoud Fallahinejad Ghajari
Name of organization / entity
Facualty of Dentistry, Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 3010
Email address
masfalnegh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Iranian Center for Endodontics Research, Shahid Beheshti University of Medical Siences
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2009-09-06, 1388/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical and radiographic success of primary molars direct pulp capping using Mineral Aggregate Trioxide and Calcium Enriched Mixture
Public title
Pulp Treatment of primary teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: at least 2 decayed primary molars, no spontaneous pain, no sensitivity to percussion/palpation, no pathologic mobility, no swelling/fistula, no forcation lucency, no internal/external root resorption. Exclusion criteria: Systemic diseases, use of special drugs, absence of accessor permanent toot, priodontal packet more than 3mm, sinus tract.
Age
From 5 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
21
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Deputy of Shahid Beheshti University Medical Siences
Street address
Next to Taleghni Haspital, Evin
City
Tehran
Postal code
Approval date
2013-09-04, 1392/06/13
Ethics committee reference number
87-01-152-5724-1060
Health conditions studied
1
Description of health condition studied
primary tooth pulp exposure
ICD-10 code
K04
ICD-10 code description
Diseases of pulp and periapical tissues
Primary outcomes
1
Description
clinical health (absence of signs and symptomes of pulp disease) of treated tooth
Timepoint
6 monts
Method of measurement
examination
2
Description
radiographic health of treated tooth
Timepoint
6 months
Method of measurement
radiography
Secondary outcomes
1
Description
Dentine Bridge Formation in exposure area
Timepoint
6 monthes
Method of measurement
Radiographic examination
Intervention groups
1
Description
pulp capping using Mineral Aggregate trioxide (MTA)
Category
Treatment - Drugs
2
Description
pulp capping using Calcium Enriched Mixture (CEM)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistey, Shahid Beheshti University of Medical Siences
Full name of responsible person
Dr.Masoud Fallahinegad Ghajari
Street address
School of Dentistry, Daneshjoo Boulevd, Evin
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian Center for Endodontic Research
Full name of responsible person
Dr.Saeed Asgary
Street address
School Dentistry, Daneshjoo Boulevd, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian Center for Endodontic Research
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, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Masou Fallahinejad Ghajari
Position
Pedodontist/Assotiated Prof.
Other areas of specialty/work
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Evin
City
Tehran
Postal code
1983963113
Phone
00982122403010 - 00982122403075
Fax
Email
masoudfallah36@yahoo.com - masfalnegh@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian Center for Endodontic Research
Full name of responsible person
Dr. Saeed Asgary
Position
Endodontist/Professor
Other areas of specialty/work
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Evin
City
Tehran
Postal code
1983963113
Phone
+98 21 2241 3897
Fax
Email
saasgary@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Maoud Fallahinejad Ghajari
Position
Pedodontist/Associated Proffesor
Other areas of specialty/work
Street address
Daneshgo Boulevard, Evin
City
Tehran
Postal code
1983963113
Phone
00982122403010 - 00982122403075
Fax
Email
masoudfallah36@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)