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 controlled clinical trial aims on a total of 90 volunteers from the population of patients with irreversible pulpitis of molar teeth, referring to the post graduate endodontic departments of dental faculty of Zahedan. Volunteers who meet the inclusion criteria are randomly (computer randomization) assigned into 3 mentioned study groups (each group consists of 30 patients) .
Settings and conduct
Location of study : Endodontic department of Zahedan university 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 50 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 tracts.
Intervention groups
1- Root Canal Therapy and coronal restoration 2- Pulpotomy with new calcium silicate Cement and coronal restoration 3- Pulpotomy with MTA and coronal restoration
Main outcome variables
Clinical and radiographic signs/symptoms at 6 months post-treatment.

General information

Reason for update
Acronym
Root canal therapy and pulpotomy
IRCT registration information
IRCT registration number: IRCT20220305054200N1
Registration date: 2022-04-25, 1401/02/05
Registration timing: registered_while_recruiting

Last update: 2022-04-25, 1401/02/05
Update count: 0
Registration date
2022-04-25, 1401/02/05
Registrant information
Name
Farnaz Faramarzian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 1814
Email address
farnazfaramarzian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-24, 1401/02/04
Expected recruitment end date
2022-10-21, 1401/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of full pulpotomy in cariously exposed mature permanent molar teeth with new calcium silicate cement : A 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 50 years Patients who accept to attend for recalls Patients who approve and sign the written informed consent
Exclusion criteria:
Patients with systemic conditions that disturb 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 15 (for 2nd molar treatment) and patients older than 50 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 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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 right after the recording of patient's demographic data and before the starting of treatment. 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 of Zahedan University of Medical Sciences
Street address
Dental Faculty Of Zahedan, Azadegan Sharghi Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Approval date
2022-02-26, 1400/12/07
Ethics committee reference number
IR.ZAUMS.REC.1400.412

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
Pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis

Primary outcomes

1

Description
Sign and symptoms of pulpal inflammation/infection (spontaneous unstimulated pain)
Timepoint
Six months after treatmentOne week and 6 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
Six months after treatmentOne week and 6 months after intervention
Method of measurement
Periapical radiographs

3

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

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Root canal therapy
Category
Prevention

2

Description
Intervention group 1: Pulpotomy with new calcium silicate cement
Category
Prevention

3

Description
Intervention group 2: Pulpotomy with MTA
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental faculty of Zahedan
Full name of responsible person
Farnaz Faramarzian
Street address
Dental Faculty Of Zahedan, Azadegan sharghi Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1814
Email
farnazfaramarzian@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Somaye Ansari Moghadam
Street address
Dental Faculty Of Zahedan, Azadegan Sharghi Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1814
Email
s_a_moghadam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
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
Zahedan University of Medical Sciences
Full name of responsible person
Farnaz Faramarzian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental Faculty Of Zahedan, Azadegan Sharghi Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1814
Fax
Email
farnazfaramarzian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farnaz Faramarzian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental Faculty Of Zahedan, Azadegan Sharghi Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1814
Fax
Email
farnazfaramarzian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farnaz Faramarzian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental Faculty Of Zahedan, Azadegan Sharghi Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1814
Fax
Email
farnazfaramarzian@gmail.com

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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