100 patients aged 10-65 years with no systemic disease of both sexes with a diagnosis of irreversible pulpitis during vitality tests were included in study.Then patients divided into two groups of 50 according to their age and level of recession of pulp chamber in their parallel radiography.patient with the age of 40 and more and calcified pulp chamber are included in aged group and patien with the age of less than 40 and without calcified pulp chamber are included in young group. After anesthetic injection and mouthwashes with Chlorhexidine 0.2 % dental caries were removed from environment to center. The tooth was isolated with rubber dam & clamp. Preparing the access cavity were completed and inflamed pulp removed by the using of diamond bur and excavator to the cervical area. In order to achieve hemostasis rinsing with sterile normal saline and using a small piece of sterile cotton Impregnated 5.25% hypochlorite sodium were used. Then CEM cement were placed in the area in 2 mm of thickness and damp cotton were used over that then dental temporary dressing were placed. The intensity of pain over 48 hours measured with VAS schedule .Clinical and radiographic evaluations at 6 and 12 months after treatment is performed to evaluate the treatment results.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051027738N2
Registration date:2016-06-16, 1395/03/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-16, 1395/03/27
Registrant information
Name
Aida Farhadi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3253 5141
Email address
a.shahravan@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An evaluation of clinical and radiographic success rate of vital pulp therapy in molars with irreversible pulpitis with young and aged pulps
Public title
An evaluation of clinical and radiographic success rate of vital pulp therapy in molars with irreversible pulpitis with young and aged pulps
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Irreversible pulpitis in molar teeth; Spontaneous, radiating and lingering tooth pain which is reproducible; Age between 10-65; Cooperative patient to follow-ups; filled informed consent.
Exclusion criteria:severe and moderate marginal periodontitis; Not restorable; internal or external resorption; some systemic diseases which affect healing of the pulp or post operative pain; pregnant women; Periapical lesions; Necessity of intrapulpal injection; Patient with traumatic occlusion
Age
From 10 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
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
Kerman University of Medical Sciences
Street address
Kerman,dental school
City
Kerman
Postal code
Approval date
2016-02-20, 1394/12/01
Ethics committee reference number
IR.Kmu.REC.1394.632
Health conditions studied
1
Description of health condition studied
irreversible pulpitis
ICD-10 code
k04.0
ICD-10 code description
Diseases of pulp and periapical tissues
Primary outcomes
1
Description
post operative tooth pain
Timepoint
after 6- 48 hours
Method of measurement
VAS
Secondary outcomes
1
Description
success rate
Timepoint
6-12 months
Method of measurement
radiographic and clinical evaluation
Intervention groups
1
Description
vital pulp therapy for aged and calcified pulp and same treatment for young group(samae intervention for two different groups)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman dental school
Full name of responsible person
Arash Shahravan
Street address
Dental school
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Aida Farhadi
Street address
Kerman, dental school
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Arash Shahravan
Position
associate peofessor of endodontics
Other areas of specialty/work
Street address
Kerman dental school
City
Kerman
Postal code
Phone
+98 34 3211 8074
Fax
Email
arashahravan@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Arash Shahravan
Position
associated professor
Other areas of specialty/work
Street address
Kerman
City
Kerman
Postal code
Phone
+98 34 3211 8074
Fax
Email
arashahravan@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Aida Farhadi
Position
Other areas of specialty/work
Street address
Kerman dental school
City
Kerman
Postal code
Phone
+98 34 3211 8025
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)