Abstract:
Aim: The purpose of this randomized, open labelled, parallel group, multicenter non-inferiority trial is to compare the outcome measures of root canal therapy and pulpotomy treatment in terms of clinical and radiographical success and also postoperative pain relieving in human permanent molar teeth diagnosed with irreversible pulpitis.
Method and Materials: Six hundred patients will participate based on established criteria, and each has a clinical signs and symptoms of an irreversible pulpitis. The patients are randomly allocated into three arms: 1- One-visit root canal therapy (ORCT: n=200) as reference treatment, 2- pulpotomy with a new endodontic cement (PNEC: n=200), and 3- pulpotomy with Mineral Trioxide Aggregate (PMTA: n=200) as new treatments. The patients will record degree of pain intensity at the baseline and following treatment on a 7-day visual analogue scale (VAS, rated 0-9). Clinical and radiographical success on a 24 month’s frame will be assessed. The data will be analyzed statistically with One- and 2-way ANOVA.
General information
Acronym
VPT
IRCT registration information
IRCT registration number:IRCT138706131191N1
Registration date:2008-10-11, 1387/07/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2008-10-11, 1387/07/20
Registrant information
Name
Saeed Asgary
Name of organization / entity
Iranian Center for Endodontic Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2241 3897
Email address
sasgari@icdr.ac.ir
Recruitment status
Recruitment complete
Funding source
shaheed beheshti medical university
office for oral health - ministry of health and medical education
Expected recruitment start date
2008-04-01, 1387/01/13
Expected recruitment end date
2008-09-30, 1387/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pulpotomy versus root canal therapy to treat irreversible pulpitis in human permanent molars: A multicenter randomized non-inferiority trial.
Public title
vital pulp therapy to treat irreversible pulpitis
Purpose
Treatment
Inclusion/Exclusion criteria
-Diagnostic criteria:
1) Patient reports pain of endodontic origin
2) Diagnosis of irreversible pulpitis
-Eligibility criteria:
1) Molar tooth
2) Patient chooses to have tooth extraction for pain relief
3) Age 9–65 years
4) Both gender
5) The patient had read and thoroughly understood the questionnaires
6) Written informed consent
-Exclusion criteria:
1) Moderate or severe periodontitis
2) None restorable tooth
3) Internal or external root resorption
4) Root canal calcification
5) No bleeding after access cavity preparation
6) Analgesic taken within the last 4 h
7) Active systemic disease
8) The patient was pregnant or nursing
9) History of opioid addiction or abuse
10) Temporary residency
Age
From 9 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
600
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
vital pulp therapy to treat irreversible pulpitis(VPT)
Secondary trial Id
NCT00748280
Registration date
2008-09-08, 1387/06/18
Ethics committees
1
Ethics committee
Name of ethics committee
Iran Center for Dental Research
Street address
5th floor , shahid beheshti dental school, Evin ,Tehran
City
Tehran
Postal code
19839613113
Approval date
empty
Ethics committee reference number
8600
Health conditions studied
1
Description of health condition studied
vital pulp therapy to treat irrevesible pulpitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
clinical success of pulpotomy
Timepoint
from treatment time to 24 month after treatment
Method of measurement
clinical examination (percusion,soft tissue palpation ,observation of periapical soft tissue)
2
Description
radiographical success of pulpotomy
Timepoint
from treatment time to 24 month after treatment
Method of measurement
priapical radiography(periodental tissue health)
Secondary outcomes
1
Description
Pain value
Timepoint
befor treatment ,6 hours after treatment ,12 hours after treatment and after that every 12 hours to 7th day.
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
one-visit root canal therapy
Category
empty
2
Description
pulpotomy with mineral trioxide aggregate
Category
empty
3
Description
pulpotomy with new endodontic cement
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti medical science university
Full name of responsible person
Dr.Taheri
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Iran medical science university
Full name of responsible person
Dr.Rahnama
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Shiraz medical science university
Full name of responsible person
Dr.Dehghan
Street address
City
Shiraz
4
Recruitment center
Name of recruitment center
Mashhad medical science university
Full name of responsible person
Dr.Heravi
Street address
City
Mashhad
5
Recruitment center
Name of recruitment center
Shahid sadooghi medical science university
Full name of responsible person
Dr.Fotoohi
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran Center of Endodontics Research center
Full name of responsible person
Dr.saeed asgary
Street address
5th floor , shahid beheshti dental school, Evin ,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran Center of Endodontics Research center
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
office for oral health-ministry of health and medical education
Full name of responsible person
Street address
City
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
office for oral health-ministry of health and medical education
Proportion provided by this source
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
endodontics research center
Full name of responsible person
mohammad jafar eghbal
Position
wise president(research)/endodontist
Other areas of specialty/work
Street address
iran center of endodontics research center, dental school of shahid beheshti university,Evin,tehran
City
Tehran
Postal code
1983963113
Phone
+98 21 2241 3897
Fax
+98 21 2242 7753
Email
mje782002@yahoo.com
Web page address
www.icdr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
iran center of endodontics research center
Full name of responsible person
saeed asgary
Position
president/endodontist
Other areas of specialty/work
Street address
iran center of endodontics research center, dental school of shahid beheshti university,Evin,tehran
City
Tehran
Postal code
1983963113
Phone
+98 21 2241 3897
Fax
+98 21 2242 7753
Email
sasgary@yahoo.com
Web page address
www.icdr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
iran center of dental research
Full name of responsible person
Bahareh Shadman
Position
dentist/DDS
Other areas of specialty/work
Street address
5th floor , shahid beheshti dental school, Evin ,Tehran
City
Tehran
Postal code
1983963113
Phone
+98 21 2241 3897
Fax
+98 21 2242 7753
Email
baharshadman@gmail.com, bahshad@yahoo.com
Web page address
www.icdr.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)