Outcome of Pulpotomy Versus Root Canal Therapy
Primary Purpose
Caries, Pulpitis - Irreversible
Status
Recruiting
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Non surgical root canal treatment
Pulpotomy
Sponsored by
About this trial
This is an interventional treatment trial for Caries
Eligibility Criteria
Inclusion Criteria:
- Medically fit patient
- mature permanent tooth with deep caries
- diagnosis of irreversible pulpits.
- tooth is restored with a direct restoration
Exclusion Criteria:
- immature teeth
- teeth were hemostasis cannot be achieved after pulpotomy
- necrotic teeth
- lack of response to cold test
Sites / Locations
- Jordan University of science and technologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Root canal treatment group
Pulpotomy group
Arm Description
This group will receive complete root canal therapy
This group will receive full pulpotomy
Outcomes
Primary Outcome Measures
Post operative pain level on numerical pain scale
Pain level after treatment will be assessed on a numerical scale from 0-10 where is zero refer to no pain and 10 is the most sever pain.
Post operative pain level on visual analogue scale
Pain level after treatment will be assessed on a visual analogy scale from 0-10, where is zero refer to no pain and 10 is the most sever pain.
Secondary Outcome Measures
Clinical success
The tooth should be pain free, no sinus tract, no tenderness to palpation and no swelling. As measured by clinical examination
Radiographic success
Periapical x-ray will be taken it should show no bone lesions or root resorption
Full Information
NCT ID
NCT05279781
First Posted
November 23, 2021
Last Updated
October 24, 2022
Sponsor
Jordan University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05279781
Brief Title
Outcome of Pulpotomy Versus Root Canal Therapy
Official Title
Quality of Life, Satisfaction and Outcome After Full Pulpotomy Compared to Root Canal Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
September 20, 2024 (Anticipated)
Study Completion Date
January 2025 (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
Root canal therapy (RCT) is indicated once the pulp is diagnosed with irreversible pulpitis. Despite favorable success rate reported for RCT in vital cases, it is time consuming, and might increases fracture susceptibility of teeth. With the advancement of materials and better understanding of pulpal healing, vital pulp therapy is practiced as an alternative treatment with high success rate. The aim of this study is to explore the outcome, quality of life and patient satisfaction after full pulpotomy compared to RCT.
Detailed Description
Permanent molar teeth with carious pulp exposure and mature roots as evident on the preoperative periapical radiograph will be included in the study. The teeth will be randomly divided into 2 groups (n=30). The first group will be treated with Biodentine full pulpotomy and the second group will be endodontically treated. Based on a previously validated questionnaire. The quality of life and satisfaction of patients after pulpotomy treatment will be evaluated compared to those after endodontic treatment. Clinical and radiographic assessment of the treated teeth will be done 3, 6 and 12 months postoperatively. Pain level will be recorded preoperatively and 1, 2, 3, 5 and 7 days after treatment.
The questionnaire consists of five components:
Characteristics of the patient; including age, gender, socioeconomic status, smoking, oral hygiene practices, frequency of dental visits, and dental history.
Postoperative complications including postoperative pain, discomfort,or swelling.
These symptoms will be evaluated after 1, 2, 3,5 and 7 days by contacting the patient on the phone and at follow up visits at 3, 6, and 12 months.
Quality of life instruments designed
Semantic scales designed to evaluate patient satisfaction with the treatment received.
Clinical and radiographic assessment of the treated teeth will be recorded. Success will be defined as clinically asymptomatic tooth with no sinus tract or swelling or periapical lesion.
Data will be analysed statistically using appropriate tests based on the distribution of the results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Pulpitis - Irreversible
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups. One will receive root canal treatment t and the other will receive pulpotomy.
Masking
Participant
Masking Description
Participant will not be informed whether complete pulp removal or partial treatment was done.
Operator and investigator cannot be blinded due to differences in the procedure and it will be evident on the radiographs, so it cannot be masked during radiographic evaluation.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Root canal treatment group
Arm Type
Active Comparator
Arm Description
This group will receive complete root canal therapy
Arm Title
Pulpotomy group
Arm Type
Active Comparator
Arm Description
This group will receive full pulpotomy
Intervention Type
Procedure
Intervention Name(s)
Non surgical root canal treatment
Intervention Description
Complete root canal treatment will be performed followed by direct restoration
Intervention Type
Procedure
Intervention Name(s)
Pulpotomy
Intervention Description
Full pulpotomy followed by direct restoration
Primary Outcome Measure Information:
Title
Post operative pain level on numerical pain scale
Description
Pain level after treatment will be assessed on a numerical scale from 0-10 where is zero refer to no pain and 10 is the most sever pain.
Time Frame
7 days
Title
Post operative pain level on visual analogue scale
Description
Pain level after treatment will be assessed on a visual analogy scale from 0-10, where is zero refer to no pain and 10 is the most sever pain.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Clinical success
Description
The tooth should be pain free, no sinus tract, no tenderness to palpation and no swelling. As measured by clinical examination
Time Frame
6, 12, 24, 48 months
Title
Radiographic success
Description
Periapical x-ray will be taken it should show no bone lesions or root resorption
Time Frame
6, 12, 24, 48 months
Other Pre-specified Outcome Measures:
Title
The quality of life questionnaire
Description
A questionnaire validated previously by Dugas et al 2002 will be used to assess Quality of life
Time Frame
6,12, 24, 48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Medically fit patient
mature permanent tooth with deep caries
diagnosis of irreversible pulpits.
tooth is restored with a direct restoration
Exclusion Criteria:
immature teeth
teeth were hemostasis cannot be achieved after pulpotomy
necrotic teeth
lack of response to cold test
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prof Taha
Phone
+962776566110
Email
n.taha@just.edu.jo
First Name & Middle Initial & Last Name or Official Title & Degree
Nessrin Taha, PhD
Phone
+962776566110
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
Principal Investigator
Facility Information:
Facility Name
Jordan University of science and technology
City
Irbid
ZIP/Postal Code
21110
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nessrin Taha, PhD
Phone
(62776566110
Email
n.taha@just.edu.jo
Phone
+962776566110
Email
nessrin_taha@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
After collection of data and publication , data might be made available for the benefit off 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
result
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Outcome of Pulpotomy Versus Root Canal Therapy
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