Comparative Study of the Outcome of Partial and Full Pulpotomy in Irreversible Pulpits
Primary Purpose
Carious Exposure of Pulp, Irreversible Pulpitis, Pulpotomy
Status
Recruiting
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Partial pulpotomy
Full Pulpotomy
Sponsored by
About this trial
This is an interventional treatment trial for Carious Exposure of Pulp focused on measuring irreversible pulpits, Pulpotomy, Outcome
Eligibility Criteria
Inclusion Criteria:
- Mature permanent tooth
- Deep caries extending more than two thirds of dentine or exposing the pulp
- Tooth responds positively to cold test
- Clinical symptoms of irreversible pulpits
- Tooth is restorable and can be restored with coronal restoration
- Bleeding normally is confirmed after pulp exposure
- hemostasis could be achieved within 8 minutes
Exclusion Criteria:
- Non restorable teeth
- necrotic teeth
- hemostasis could not be achieved within 8 minutes
Sites / Locations
- Jordan University of science and technologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Partial Pulpotomy
Full Pulpotomy
Arm Description
After pulp exposure 2-3 mm of the pulp tissue will be amputated, a calcium silicate based material will be placed over the pulp and the tooth will be restored.
After pulp exposure the entire coronal pulp to the level of canal orifices will be amputated , calcium silicate based material will be placed over the pulp and the tooth will be restored.
Outcomes
Primary Outcome Measures
Post operative pain level measured by visual analogy scale from 0-10
scale from 0-10
Post operative pain level measured by a numerical scale from 0-10
scale from 0-10
Secondary Outcome Measures
Clinical success as measured by clinical examination
The tooth should be pain free, no sinus tract or swelling, no tenderness to palpation as determined by clinical examination
Radiographic success as evaluated by periapical x-rays
There should be no evidence of bone resorption or root resorption on the x-ray
Full Information
NCT ID
NCT05279820
First Posted
November 28, 2021
Last Updated
March 14, 2022
Sponsor
Jordan University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05279820
Brief Title
Comparative Study of the Outcome of Partial and Full Pulpotomy in Irreversible Pulpits
Official Title
Full Versus Partial Pulpotomy in the Management of Teeth With Clinical Diagnosis of Irreversible Pulpits: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jordan University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims at comparing the outcome of partial pulpotomy and full pulpotomy in the management of carious pulp exposures in permanent teeth with a clinical diagnosis of irreversible pulpits. The primary outcome is resolution of symptoms and the secondary outcome is clinical and radiographic normality at 1 and 2 years follow up.
The study design will be a double blind randomized clinical trial.
Detailed Description
Aim: to compare the outcome of partial and full pulpotomy in managing carious pulp exposures in mature permanent teeth with symptoms of irreversible pulpitis
Methods: Assuming a 10% difference in the success rate in favor of pulpotomy, with 80% power and accounting for possible 10% attrition, the minimum sample size required is estimated to be 80 teeth in 80 patients in every arm.
Patients referred to the postgraduate Endodontic clinic for management of deep carious lesions with symptoms of irreversible pulpits will be assessed for inclusion in the study according to preset inclusion criteria. After a written informed consent baseline demographics of patients and teeth will be recorded.
Pulpotomy (partial or full using block randomization) will be performed under aseptic procedures and the tooth will be permanently restored. Post operative baseline radiographs will be taken.
Primary outcome will be assessed after 48 hours. secondary outcome will be assessed at 6 months, 1 year and 2 years post operatively.
Data of outcome and effect of preoperative and intraoperative variables on the outcome will be compared statistically using appropriate tests
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carious Exposure of Pulp, Irreversible Pulpitis, Pulpotomy
Keywords
irreversible pulpits, Pulpotomy, Outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will run concurrently and the participants will randomly distributed between the two interventions using a block randomization procedure
Masking
ParticipantOutcomes Assessor
Masking Description
The participant will not be informed whether the treatment performed was partial or full pulpotomy the outcome assessor will be blinded to the type of treatment performed, and evaluation of the radiographs will include masking the crown so that the procedure cannot be identified.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Partial Pulpotomy
Arm Type
Active Comparator
Arm Description
After pulp exposure 2-3 mm of the pulp tissue will be amputated, a calcium silicate based material will be placed over the pulp and the tooth will be restored.
Arm Title
Full Pulpotomy
Arm Type
Active Comparator
Arm Description
After pulp exposure the entire coronal pulp to the level of canal orifices will be amputated , calcium silicate based material will be placed over the pulp and the tooth will be restored.
Intervention Type
Procedure
Intervention Name(s)
Partial pulpotomy
Intervention Description
Partial pulp tissue amputation
Intervention Type
Procedure
Intervention Name(s)
Full Pulpotomy
Intervention Description
Full Pulpotomy
Primary Outcome Measure Information:
Title
Post operative pain level measured by visual analogy scale from 0-10
Description
scale from 0-10
Time Frame
48 hours
Title
Post operative pain level measured by a numerical scale from 0-10
Description
scale from 0-10
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Clinical success as measured by clinical examination
Description
The tooth should be pain free, no sinus tract or swelling, no tenderness to palpation as determined by clinical examination
Time Frame
6, 12, 24 months
Title
Radiographic success as evaluated by periapical x-rays
Description
There should be no evidence of bone resorption or root resorption on the x-ray
Time Frame
6, 12, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Mature permanent tooth
Deep caries extending more than two thirds of dentine or exposing the pulp
Tooth responds positively to cold test
Clinical symptoms of irreversible pulpits
Tooth is restorable and can be restored with coronal restoration
Bleeding normally is confirmed after pulp exposure
hemostasis could be achieved within 8 minutes
Exclusion Criteria:
Non restorable teeth
necrotic teeth
hemostasis could not be achieved within 8 minutes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nessrin Taha, PhD
Phone
+962776566110
Email
n.taha@just.edu.jo
First Name & Middle Initial & Last Name or Official Title & Degree
Nessrin Taha, PhD
Email
nessrin_taha@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nessrin Taha, PhD
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Jordan University of science and technology
City
Irbid
ZIP/Postal Code
22110
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nessrin Taha, DCD
Email
n.taha@just.edu.jo
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Until the time of completion of the study, ankylosis of data and submission for publication, then data can be provided to other researchers
Citations:
PubMed Identifier
32950193
Citation
Taha NA, About I, Sedgley CM, Messer HH. Conservative Management of Mature Permanent Teeth with Carious Pulp Exposure. J Endod. 2020 Sep;46(9S):S33-S41. doi: 10.1016/j.joen.2020.06.025.
Results Reference
background
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Comparative Study of the Outcome of Partial and Full Pulpotomy in Irreversible Pulpits
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