Protocol summary

Study aim
Comparison of the outcome of pulpotomy on permanent mature molars with carious pulp exposure with conventional root canal therapy
Design
This multi-center randomized controlled clinical trial (phase 3) aims on a total of 900 volunteers from the population of patients with irreversible pulpitis of molar teeth, referring to the post graduate endodontic departments of participating universities. Volunteers who meet the inclusion criteria are randomly (computer randomization) assigned into 3 mentioned study groups (each group consists of 300 patients) .
Settings and conduct
Location of study : Endodontic department of Shahid Beheshti, Tabriz, Shahed, Azad, Khorasgan, Yazd, Kerman, Zahedan, Shiraz universities of medical sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria : A vital molar tooth A history of pain indicating irreversible pulpitis Patients in the range of 12 to 65 years Patients who accept to be and will be available for recalls Patients who approve and sign the written informed consent Exclusion Criteria : Patients with systemic conditions that disturb tissue healing process. Pregnant/nursing women Physically disabled or mentally retarded patients Teeth require complicated build-ups, crown lengthening or prosthetic crown. Teeth with localized periodontal disease (i.e. probing depth more than 3 mm) Internal/external root resorption or pulp calcification Teeth with history of trauma or Swelling of surrounding soft tissues Teeth with immature apices or with Presence of sinus tract
Intervention groups
1- Root Canal Therapy and coronal restoration 2- Pulpotomy with CEM Cement and coronal restoration 3- Pulpotomy with ProRoot MTA and coronal restoration
Main outcome variables
Clinical and radiographic signs/symptoms at 6, 12 and 24 months post-treatment.

General information

Reason for update
Acronym
Root canal therapy and pulpotomy
IRCT registration information
IRCT registration number: IRCT20151226025695N3
Registration date: 2019-02-06, 1397/11/17
Registration timing: retrospective

Last update: 2019-02-06, 1397/11/17
Update count: 0
Registration date
2019-02-06, 1397/11/17
Registrant information
Name
Ali Haeri
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Dental School
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 6397
Email address
ali_haeri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Ministry of Health and Medical Education, Islamic Republic of Iran, Shahid Beheshti University of Medical Sciences, Research Institute of Dental Sciences, Iranian Center for Endodontic Research
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the outcome of pulpotomy on permanent mature molars with carious pulp exposure with conventional root canal therapy: A comparative randomized clinical trial
Public title
Outcome of root canal therapy and pulpotomy on permanent mature molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A vital molar tooth (confirmed with cold spray and electric pulp tester before treatment and visual inspection of pulpal hemorrhage after access cavity preparation) A history of pain indicating irreversible pulpitis (i.e. spontaneous localized/generalized pain, pain stimulated by hot and cold fluids that lasts after elimination of the stimulus and is reproducible with cold testing) Pulp exposure during caries removal when no sign of irreversible pulpitis is present Patients in the range of 12 to 65 years Patients who accept to attend for recalls Patients who approve and sign the written informed consent
Exclusion criteria:
Patients with systemic conditions that disturbe tissue healing process (including diabetes, cancer, endocrine diseases, AIDS and consumption of corticosteroids) Patients with epinephrine intolerance Pregnant/nursing women Physically disabled or mentally retarded patients Patients with poor oral hygiene or those with periodontal diseases, where the long term preservation of the tooth may not be possible Immigrants such as those from Afghanistan, who are likely to leave the country during the subsequent two years Patients younger than 12 (for 1st molar treatment) and 17 (for 2nd molar treatment) and patients older than 65; Non-vital/partially necrotic teeth confirmed with primary examinations or diagnosed after access cavity preparation Teeth with pulpal inflammation spreading beyond the canal orifices, and continuous bleeding after placement of cotton pellet soaked in 2.5% sodium hypochlorite for a maximum of 10 minutes Teeth that are not appropriate candidates for class I and II (Occlusal, MO, DO, MOD) restoration and require complicated build-ups, crown lengthening or prosthetic crown Teeth with localized periodontal disease (i.e. probing depth more than 3 mm) where the tooth survival is not endangered but pulpal irritation and disturbed healing due to root exposure is likely Internal/external root resorption or pulp calcification detectable in periapical radiography Teeth with history of trauma Swelling of surrounding soft tissues Teeth with immature apices Presence of sinus tract
Age
From 12 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 900
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a software has been designed to randomize the treatment group of participating patients. For each practitioner, eligible patients will be randomized into three study arms, using a computer-generated system; Randomization performed online via www.mcrct.ir website right after the recording of patient's demographic data and before the starting of treatment (allocation concealment). Patients stratified with 1:1:1 allocation in the three study arms.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Research Institute of Dental Sciences, Iranian Center for Endodontic Research, Sha
Street address
Research Institute of Dental Sciences, Shahid Beheshti Dental School, Evin
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2017-01-12, 1395/10/23
Ethics committee reference number
IR.SBMU.RIDS.REC.1395.320

Health conditions studied

1

Description of health condition studied
Diseases of pulp and periapical tissues
ICD-10 code
K04
ICD-10 code description
Diseases of pulp and periapical tissues

2

Description of health condition studied
Inflammation of the pulp
ICD-10 code
K04.0
ICD-10 code description
Pulpitis

3

Description of health condition studied
Necrosis of pulp
ICD-10 code
K04.1
ICD-10 code description
Necrosis of pulp

4

Description of health condition studied
Pulp degeneration
ICD-10 code
K04.2
ICD-10 code description
Pulp degeneration

5

Description of health condition studied
Acute apical periodontitis of pulpal origin
ICD-10 code
K04.4
ICD-10 code description
Acute apical periodontitis of pulpal origin

6

Description of health condition studied
Chronic apical periodontitis
ICD-10 code
K04.5
ICD-10 code description
Chronic apical periodontitis

7

Description of health condition studied
Periapical abscess with sinus
ICD-10 code
K04.6
ICD-10 code description
Periapical abscess with sinus

8

Description of health condition studied
Periapical abscess without sinus
ICD-10 code
K04.7
ICD-10 code description
Periapical abscess without sinus

Primary outcomes

1

Description
Sign and symptoms of pulpal inflammation/infection (spontaneous unstimulated pain)
Timepoint
One week and 6, 12 and 24 months after intervention
Method of measurement
Clinical examination and VAS (visual analogue scale) questionnaire

2

Description
Sign and symptoms of pulpal inflammation (internal/external resorption)
Timepoint
One week and 6, 12 and 24 months after intervention
Method of measurement
Periapical radiographs

3

Description
Sign and symptoms of periapical inflammation (pain on percussion and palpation)
Timepoint
One week and 6, 12 and 24 months after intervention
Method of measurement
Clinical examination and VAS (visual analogue scale) questionnaire

4

Description
Sign and symptoms of periapical infection (pain, redness, swelling or formation of sinus tract)
Timepoint
One week and 6, 12 and 24 months after intervention
Method of measurement
Clinical examination and VAS (visual analogue scale) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Pulpotomy with CEM Cement
Category
Prevention

2

Description
Intervention group 2: Pulpotomy with ProRoot MTA
Category
Prevention

3

Description
Control group: Root canal therapy
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Post Graduate Endodontic Department of Shahid Beheshti Dental School
Full name of responsible person
Ali Haeri
Street address
Department of Endodontics, Shahid Beheshti Dental School, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1936833481
Phone
+98 21 2242 7753
Email
haeri.a@yahoo.com

2

Recruitment center
Name of recruitment center
Post Graduate Endodontic Department of Tehran Azad University, Dental School
Full name of responsible person
Ali Haeri
Street address
Department of Endodontics, Shahid Beheshti Dental School, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1936833481
Phone
+98 21 2242 7753
Email
haeri.a@yahoo.com

3

Recruitment center
Name of recruitment center
Post Graduate Endodontic Department of Shahed Dental School
Full name of responsible person
Ali Haeri
Street address
Department of Endodontics, Shahid Beheshti Dental School, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1936833481
Phone
+98 21 2242 7753
Email
haeri.a@yahoo.com

4

Recruitment center
Name of recruitment center
Post Graduate Endodontic Department of Tabriz Dental School
Full name of responsible person
Ali Haeri
Street address
Department of Endodontics, Shahid Beheshti Dental School, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1936833481
Phone
+98 21 2242 7753
Email
haeri.a@yahoo.com

5

Recruitment center
Name of recruitment center
Post Graduate Endodontic Department of Yazd Dental School
Full name of responsible person
Ali Haeri
Street address
Department of Endodontics, Shahid Beheshti Dental School, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1936833481
Phone
+98 21 2242 7753
Email
haeri.a@yahoo.com

6

Recruitment center
Name of recruitment center
Post Graduate Endodontic Department of Kerman Dental School
Full name of responsible person
Ali Haeri
Street address
Department of Endodontics, Shahid Beheshti Dental School, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1936833481
Phone
+98 21 2242 7753
Email
haeri.a@yahoo.com

7

Recruitment center
Name of recruitment center
Post Graduate Endodontic Department of Zahedan Dental School
Full name of responsible person
Ali Haeri
Street address
Department of Endodontics, Shahid Beheshti Dental School, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1936833481
Phone
+98 21 2242 7753
Email
haeri.a@yahoo.com

8

Recruitment center
Name of recruitment center
Post Graduate Endodontic Department of Khorasgan Azad University, Dental School
Full name of responsible person
Ali Haeri
Street address
Department of Endodontics, Shahid Beheshti Dental School, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1936833481
Phone
+98 21 2242 7753
Email
haeri.a@yahoo.com

9

Recruitment center
Name of recruitment center
Post Graduate Endodontic Department of Shiraz Dental School
Full name of responsible person
Ali Haeri
Street address
Department of Endodontics, Shahid Beheshti Dental School, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1936833481
Phone
+98 21 2242 7753
Email
haeri.a@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Ministry of Health and Medical Education, Islamic Republic of Iran
Full name of responsible person
Dr. Ali Asghar Peyvandi
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2242 7753
Email
haeri.a@yahoo.com
Grant name
Grant code / Reference number
IR.SBMU.RIDS.REC.1395.320
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Ministry of Health and Medical Education, Islamic Republic of Iran
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Department of Endoodntics, Shahid Beheshti Dental School
Full name of responsible person
Ali Haeri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Dental School, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2241 3897
Fax
Email
Haeri.a@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Endodontics, Shahid Beheshti Dental School
Full name of responsible person
Mohammad Jafar Eghbal
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Dental School, Danshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
00219822413897
Fax
Email
mje782002@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iranian Center for Endodontic Research, Research Institute of Dental Sciences, Shahid Beheshti Denta
Full name of responsible person
Mahta Fazlyab
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Dental School, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 22413897
Fax
Email
dr.mfazlyab@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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