The present study aims to investigate the response to pulp sensitivity tests after complete pulpotomy in mandibular permanent teeth with symptomatic irreversible pulpitis.
Design
The clinical trial has an intervention group and is conducted on 36 patients.
Settings and conduct
The present study is conducted in clinics and private offices in Ilam city.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Age range 16-35 years
- adult permanent mandibular molars with deep or very deep occlusal/proximal caries with marked irreversible pulpitis
- After providing complete and informative explanations about Root Canal therapy (RCT) and complete pulpotomy, its advantages and disadvantages and success and failure rates in this type of treatment, complete pulpotomy was performed with the patient's consent. If the treatment fails, RCT treatment is used as an alternative treatment.
Exit criteria:
- Caries in the buccal and lingual area
- History of trauma and orthodontic treatment and therapy and special parafunctional habits
- Mandibular molar teeth with proximal occlusal decay with diagnosis of necrosis and reversible pulpitis
Intervention groups
In the present study, electric pulp test and cold test are used to check the success rate of complete pulpotomy treatment after 12 months. First intervention: electrical test, second intervention: cold test
Main outcome variables
suggestion an effective pulp sensitivity test in the field of complete pulpotomy in mandibular permanent teeth with symptomatic irreversible pulpitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230525058289N1
Registration date:2023-06-14, 1402/03/24
Registration timing:registered_while_recruiting
Last update:2023-06-14, 1402/03/24
Update count:0
Registration date
2023-06-14, 1402/03/24
Registrant information
Name
mehdi ziagham ahvaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 8541
Email address
mehdiziagham@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-11, 1402/03/21
Expected recruitment end date
2023-07-12, 1402/04/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation Response to Pulp Sensitivity Tests after Full Pulpotomy in Permanent Mandibular Teeth with Symptomatic Irreversible Pulpitis
Public title
Investigation Response to Pulp Sensitivity Tests after Full Pulpotomy in Permanent Mandibular Teeth with Symptomatic Irreversible Pulpitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 16-35 years
adult permanent mandibular molars with deep or very deep occlusal/proximal caries with marked irreversible pulpitis
After providing complete and informative explanations about RCT treatment and complete pulpotomy, its advantages and disadvantages and success and failure rates in this type of treatment, complete pulpotomy was performed with the patient's consent. In case of treatment failure, RCT treatment was used as an alternative treatment.
Exclusion criteria:
Buccal and lingual caries
History of trauma and orthodontic and restorative treatments as well as specific parafunctional habits
Mandibular molar teeth with proximal occlusal caries with diagnosis of necrosis and reversible pulpitis
Age
From 16 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ilam University of Medical Sciences
Street address
Ilam University of Medical Sciences campus, Banganjab, Research Blvd, Ilam
City
ilam
Province
Ilam
Postal code
6939177143
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.MEDILAM.REC.1402.025
Health conditions studied
1
Description of health condition studied
In this study, patients with adult permanent teeth with deep or very deep occlusal/proximal caries with symptomatic irreversible pulpitis are examined.
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Success and failure of full pulpotomy
Timepoint
Success was assessed 12 months after full pulpotomy
Method of measurement
- Examination of radiographs, clinical examination (using cold and electrical tests)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, two electric and cold tests were used to check the success of full pulpotomy treatment. First intervention: Electric test: In the electric pulp test, the opposite and treated tooth is removed with a cotton roll. The lip clip is placed in the corner of the patient's mouth. The tip of the electrode is covered with water-based gel and is placed between the gingival edge and the occlusal edge of the buccal surface of the mandibular molar tooth, and the contact of the electrode with the free edge of the gingiva is prevented. Finally, the patient is asked to raise his hand if he feels any emotion. The response is recorded as "Reply Received" or "No Response". The second intervention: Cold test: The cold test is performed using a cooling spray of tetrafluoroethene 2,1,1,1 and size 2 cotton, which is applied in the same position as the electric electrode on the buccal surface of the tooth. This test is performed by an endodontist for 5 seconds.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics and private offices in Ilam city
Full name of responsible person
Dr Amin Kheytri
Street address
3rd Floor, Razi Complex, Adib Alley, South Saadi, Ilam
City
Ilam
Province
Khouzestan
Postal code
6931916564
Phone
+98 912 675 4750
Email
amin.kheiry64@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Abas Maleki
Street address
Ilam University of Medical Sciences campus, Banganjab, Research Blvd, Ilam
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
info@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Mehdi Ziagham Ahwaz
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 21, between Nabii and Razavi, Mohammadian St, South Shariati,
City
Ahwaz
Province
Khouzestan
Postal code
6194695761
Phone
+98 61 3222 8541
Email
mehdiziagham@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Mehdi Ziagham Ahwaz
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 21, between Nabii and Razavi, Mohammadian St, South Shariati
City
Ahwaz
Province
Khouzestan
Postal code
6194695761
Phone
+98 61 3222 8541
Email
mehdiziagham@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Mehdi Ziagham Ahwaz
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 21, between Nabii and Razavi, Mohammadian St, South Shariati, Ahwaz
City
Ilam
Province
Ilam
Postal code
6194695761
Phone
+98 61 3222 8541
Email
mehdiziagham@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Title and more details about the data/document
Data of patients after full pulpotomy in mandibular permanent teeth with symptomatic irreversible pulpitis
When the data will become available and for how long
The access period starts 1 year after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Other statistical analyzes are allowed in these data.
From where data/document is obtainable
Send a message to the following email to receive the data
mehdiziagham@yahoo.com
What processes are involved for a request to access data/document