The aim of this clinical case report study is to evaluate long term clinical, radiological and histological effects of Theracal in partial pulpotomy of human dental pulp. Theracal is a new light-cured resin-modified calcium silicate-filled material, which sets in 20 sec (Bisco Inc, Schamburg, IL, USA). Before the operative protocol a mandibular left Third molar of a 28 years old patient will be examined radiologically and clinically, then the tooth will be mechanically cleaned and disinfected with 0.2% chlorhexidine solution. After local Anesthesia and rubberdam application, oclusal class1 cavity will be prepared by a sterile round diamond bur. Bleeding of the exposed pulp will be controlled with saline irrigation and a sterile cotton pellet Then Theracal will be prepared as a manufacture’s recommendation and applied on exposure site and finally the tooth restores with glassinomer. Patient will be called back after one year for postoperative clinical and radiographical examinations and the tooth will be extracted for histological examinations. Inclusion criteria are: age (18-32), erupted third molar, closed apex, caries free, normal signs to vitality tests and exclusion criteria are: external or internal resorption and periapical lesion. The main outcome measure is pulp health and dentine barrier formation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041120004N4
Registration date:2016-05-25, 1395/03/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-25, 1395/03/05
Registrant information
Name
Hengameh Bakhtiar
Name of organization / entity
Islamic Azad University of Tehran, faculty of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 912 813 2267
Email address
h_bakhtiar@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-12-31, 1393/10/10
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical,radiological,histological long term effects of Theracal in partial pulpotomy of human dental pulp
Public title
Long term effects of Theracal in partial pulpotomy of human dental pulp
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria are: age (18-32), erupted third molar, closed apex, caries free, normal signs to vitality tests and exclusion criteria are: external or internal resorption and periapical lesion. The main outcome measure is pulp health and dentine barrier formation
Age
From 18 years old to 32 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
1
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Moral committee of islamic azad dental university of tehran
Street address
#10 Neyestan, Pasdaran Ave, Tehran, Iran
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
0821.p.166.5
Health conditions studied
1
Description of health condition studied
Vital pulp therapy
ICD-10 code
IA49.1
ICD-10 code description
Infection disease
Primary outcomes
1
Description
Pulp health(sensitivity,pain)
Timepoint
Just after intervention,each month till one year
Method of measurement
Vitality test,cold test,EPT
2
Description
Sign of preapical pathology
Timepoint
Before intervention,before extraction
Method of measurement
Periapical radiography
Secondary outcomes
1
Description
Dentin bridge formation
Timepoint
One year after invention
Method of measurement
Histologic examination after tooth extraction
Intervention groups
1
Description
Before the operative protocol, the tooth will be radiologically examined to exclude the presence of caries or periapical pathology. Thermal testing and electric sensitivity testing will perform to assess pulp vitality. Before cavity preparation, the tooth will mechanically be cleaned and disinfected with 0.2% chlorhexidine solution. After local anesthesia (Septodont, Saint Maur des Fosses, France) and rubber dam application, occlusal Class I cavities will prepare by using round sterile diamond bur at high speed under air-distillated water spray coolant. An exposure of approximately 1.2 mm in diameter will be made with round carbide bur (4 1.2 mm) under sterile saline cooling. Bleeding will be controlled with saline irrigation, and a sterile cotton pellet is placed onto the pulp exposure site and will be capped with Theracal according to the manufacturer’s recommendations. Theracal is a calcium silicate resin based material that cures in 20 seconds and is used for direct and indirect pulpcapping. It contains approximately 45% wt mineral material, 10% wt radiopaque component, 5% wt hydrophilic thickening agent and approximately 45% resin. The patent stated that the resin consists of a hydrophobic component such as urethane dimethacrylate, bisphenol A-glycidyl methacrylate, triethylene glycol dimethacrylate and a hydrophilic component such as hydroxyethymethacrylate and polyethylene glycol dimethlacrylate. After placing a 2 mm layer of Theracal paste and polymerization for 20 s, the teeth will be provisionally restored with glass ionomer cement (GC).After a year after radio graphical and clinical examinations the tooth will be extracted and will be sent to a talented pathologist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic azad dental unversity
Full name of responsible person
Dr Hengameh Bakhtiar
Street address
#10 Neyestan, Pasdaran Ave, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic azad dental university
Full name of responsible person
Dr Hengameh Bakhtiar
Street address
#10 Neyestan, Pasdaran Ave, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic azad dental university
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
Islamic azad dental university
Full name of responsible person
Dr Hengameh Bakhtiar
Position
Endodontist
Other areas of specialty/work
Street address
#10 Neyestan, Pasdaran Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8820 2705
Fax
Email
H_bakhtiar@dentaliau.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic azad dental university
Full name of responsible person
Dr Hengameh Bakhtiar
Position
Endodontist
Other areas of specialty/work
Street address
#10 Neyestan, Pasdaran Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8820 2705
Fax
Email
H_bakhtiar@dentaliau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic azad dental university
Full name of responsible person
Fatemeh Abedi, Fereshteh Naghi Moosavi
Position
Endodontist
Other areas of specialty/work
Street address
#10 Neyestan, Pasdaran Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8820 2705
Fax
Email
H_bakhtiar@dentaliau.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)