The purpose of this clinical study is to evaluate the clinical effect of calcium-enriched cement in pulpotomy of primary molars with irreversible pulpitis. The Inclusion criterion is carious lesion on vital molar teeth surfaces. The exclusion criteria are children with systemic diseases, children with extremely poor oral hygiene, teeth with external or internal root resorption, root canal calcification and non-restorable teeth. In this l study, 50 patients aged 4 to 7 years are selected through simple sampling method from Faculty of Dentistry in Shiraz. Intervention in this study is pulpotomy with Calcium enriched cement: After adequate local anesthesia, the pulpotomy procedures were performed with rubber dam or cotton plate isolation following complete removal of caries using fissure diamond burs and round stainless steel burs. . Following coronal pulp amputation, the pulp chamber was irrigated using normal saline as well as cotton pellets wetted with normal saline to homeostasis. A base of about 2 mm CEM cement (BioniqueDent, Tehran, Iran) was placed over the amputation site. A wet cotton pellet was placed over the cement and the teeth were temporarily sealed with zinc phosphate cement. Data of this intervention are collected in four stages: 1. One week after the intervention 2. Three months after the intervention 3. Six months after the intervention 4. Twelve months after the intervention. Primary outcomes include: Swelling, tenderness to percussion, pathologic mobility, redness and pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310257402N4
Registration date:2013-11-21, 1392/08/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-21, 1392/08/30
Registrant information
Name
Mahtab Memarpour
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 3192
Email address
memarpour@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-08-27, 1392/06/05
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of pulpotomy of primary molar teeth with Calcium-enriched mixture in children 4 to 7 years with irreversible pulpitis
Public title
Pulpotomy of primary molar teeth with
irreversible pulpitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Carious lesion on the molar tooth surface not extending toward the root; Vital molar teeth.
Exclusion criteria: Children with systemic diseases; Children with extremely poor oral hygiene; Children with periodontal problems; Teeth with external or internal root resorption; Root canal calcification in pre-treatment radiographs; Non-restorable teeth.
Age
From 4 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
1
Registry name
Clinicaltrials.gov
Secondary trial Id
NCT01561183
Registration date
2012-03-14, 1390/12/24
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Pediatric Dentistry Department, Faculty of Dentistry, Ghomabad, Ghasrodasht
City
Shiraz
Postal code
Approval date
2013-08-24, 1392/06/02
Ethics committee reference number
CT-P-92-5759
Health conditions studied
1
Description of health condition studied
Pulpotomy of primary molar teeth with
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Pathologic mobility
Timepoint
Seventh day
Method of measurement
Physical examination, Observation
2
Description
Pain
Timepoint
Seventh day, Three months after the intervention, Six months after the intervention, Twelve months after the intervention
Method of measurement
Physical examination, Observation
3
Description
Abscess
Timepoint
Seventh day, Three months after the intervention, Six months after the intervention, Twelve months after the intervention
Method of measurement
Physical examination, Observation
4
Description
Swelling
Timepoint
Seventh day, Three months after the intervention, Six months after the intervention, Twelve months after the intervention
Method of measurement
Physical examination, Observation
5
Description
Tenderness to percussion
Timepoint
Seventh day, Three months after the intervention, Six months after the intervention, Twelve months after the intervention
Method of measurement
Physical examination
6
Description
Redness
Timepoint
Three months after the intervention, Six months after the intervention, Twelve months after the intervention
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
pulpotomy with Calcium enriched cement: After obtaining adequate local anesthesia, the pulpotomy procedures were performed with rubber dam or cotton plate isolation following complete removal of caries using fissure diamond burs and round stainless steel burs. . Following coronal pulp amputation, the pulp chamber was irrigated using normal saline as well as cotton pellets wetted with normal saline to homeostasis. A base of about 2 mm CEM cement (BioniqueDent, Tehran, Iran) was placed over the amputation site. A wet cotton pellet was placed over the cement and the teeth were temporarily sealed with zinc phosphate cement.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Faculty of Dentistry
Full name of responsible person
Mahtab Memarpour
Street address
Pediatric Dentistry Department, Faculty of Dentistry, Ghomabad, Ghasrodasht
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Ali Poust Foroushfard
Street address
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Position
Associate Professor of Pediatric Dentistry / Faculty
Other areas of specialty/work
Street address
Pediatric Dentistry Department, Faculty of Dentistry, Ghomabad, Ghasrodasht
City
Shiraz
Postal code
Phone
+98 71 1626 3192
Fax
Email
memarpour@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Position
Associate Professor of Pediatric Dentistry / Faculty
Other areas of specialty/work
Street address
Pediatric Dentistry Department, Faculty of Dentistry, Ghomabad, Ghasrodasht
City
Shiraz
Postal code
Phone
+98 71 1626 3192
Fax
Email
memarpour@sums.c.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Position
Associate Professor of Pediatric Dentistry / Faculty
Other areas of specialty/work
Street address
Pediatric Dentistry Department, Faculty of Dentistry, Ghomabad, Ghasrodasht
City
Shiraz
Postal code
Phone
+98 71 1626 3192
Fax
Email
memarpour@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)