Evaluation of Post Operative Pain and Success Rate After Pulpotomy
Primary Purpose
Root Canal Infection
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
vital pulp therapy
Sponsored by
About this trial
This is an interventional treatment trial for Root Canal Infection focused on measuring pulpotomy, Tricalcium silicate, Biodentine, vital pulp therapy
Eligibility Criteria
Inclusion Criteria:
Patients age between 20 and 40 years old.
- Teeth diagnosed with symptomatic irreversible pulpitis.
- Normal periapical condition confirmed by normal periapical radiograph or that with minimal widening of the PDL space.
- The teeth are restorable.
- Teeth probing depth and mobility should be within normal limits.
Exclusion Criteria:
Teeth with immature roots
- Non restorable teeth
- Bleeding could not be controlled after pulpotomy in 10 minutes.
- Medically compromised patients with systemic complication that would alter the treatment.
Sites / Locations
- Ain Shams UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
biodentine
Theracal PT
Neo Putty
Arm Description
pulptomy with biodentine
pulpotomy with Theracal PT
pulpotomy with Neo putty
Outcomes
Primary Outcome Measures
post operative pain
Each patient will be asked to fill the visual analogue scale to rate the pain level
post operative pain
Each patient will be asked to fill the visual analogue scale to rate the pain level
post operative pain
Each patient will be asked to fill the visual analogue scale to rate the pain level
post operative pain
Each patient will be asked to fill the visual analogue scale to rate the pain level
post operative pain
Each patient will be asked to fill the visual analogue scale to rate the pain level
post operative pain
Each patient will be asked to fill the visual analogue scale to rate the pain level
Secondary Outcome Measures
Pulpotomy success
clinical and radiographic absence of inflammation
Pulpotomy success
clinical and radiographic absence of inflammation
Pulpotomy success
clinical and radiographic absence of inflammation
Pulpotomy success
clinical and radiographic absence of inflammation
Pulpotomy success
clinical and radiographic absence of inflammation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04933955
Brief Title
Evaluation of Post Operative Pain and Success Rate After Pulpotomy
Official Title
Comparative Evaluation of Post Operative Pain and Success Rate After Pulpotomy Using Different Tricalcium Silicate Based Materials (A Randomized Clinical Trial )
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
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
The aim of this randomized controlled trial is to assess the post-operative pain as primary outcome and the success rate as secondary outcome after pulpotomy using different calcium silicate based materials in mature permanent teeth diagnosed with irreversible pulpitis.
Detailed Description
Setting and location :
Out-patients clinic of Endodontic Department, Faculty of Dentistry, Ain Shams University
Patient allocation:
Using computer generated randomization (www.randome.org), the participants will allocated randomly into three groups .
The sequentially numbers that will be generated, will be placed in opaque envelope until the intervention and each participant will be asked to select an envelope that determine which group of intervention he will be assigned.
Patient Classification:
Patients will be randomly divided into three groups according to material used in pulpotomy Group (1) Biodentine (n=20) Group (2) theracal PT (n=20) Group (3) Neoputty (n=20)
Procedural steps:
Pain scale chart will be given to each patient to rate his /her pain level before endodontic treatment as preoperative reading on a visual analogue scale (VAS)
Tooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000.
Rubber dam isolation of tooth
Tooth surface disinfection using guaze soaked in 5.25% sodium hypochlorite
Access cavity will be performed using a carbide steel round bur and tapered diamond stone until complete deroofing.
Using a sterile excavator, the coronal pulp tissue will be excavated14
Cotton pellets soaked in 2.5 % sodium hypochlorite will be used to achieve hemostasis for 2-3 minutes
Once hemostasis will be achieved one of the three materials will be placed according to the manufacturer's instructions
Final restoration will be placed
Methods of evaluation
Post operative pain
Pulpotomy success rate
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Canal Infection
Keywords
pulpotomy, Tricalcium silicate, Biodentine, vital pulp therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
biodentine
Arm Type
Active Comparator
Arm Description
pulptomy with biodentine
Arm Title
Theracal PT
Arm Type
Active Comparator
Arm Description
pulpotomy with Theracal PT
Arm Title
Neo Putty
Arm Type
Active Comparator
Arm Description
pulpotomy with Neo putty
Intervention Type
Procedure
Intervention Name(s)
vital pulp therapy
Intervention Description
pulpotomy
Primary Outcome Measure Information:
Title
post operative pain
Description
Each patient will be asked to fill the visual analogue scale to rate the pain level
Time Frame
pre-operative
Title
post operative pain
Description
Each patient will be asked to fill the visual analogue scale to rate the pain level
Time Frame
6 hours following the end of the procedure.
Title
post operative pain
Description
Each patient will be asked to fill the visual analogue scale to rate the pain level
Time Frame
12 hours following the end of the procedure.
Title
post operative pain
Description
Each patient will be asked to fill the visual analogue scale to rate the pain level
Time Frame
24 hours following the end of the procedure.
Title
post operative pain
Description
Each patient will be asked to fill the visual analogue scale to rate the pain level
Time Frame
48 hours following the end of the procedure.
Title
post operative pain
Description
Each patient will be asked to fill the visual analogue scale to rate the pain level
Time Frame
72 hours following the end of the procedure.
Secondary Outcome Measure Information:
Title
Pulpotomy success
Description
clinical and radiographic absence of inflammation
Time Frame
3 months after the intervention
Title
Pulpotomy success
Description
clinical and radiographic absence of inflammation
Time Frame
6 months after the intervention
Title
Pulpotomy success
Description
clinical and radiographic absence of inflammation
Time Frame
9 months after the intervention
Title
Pulpotomy success
Description
clinical and radiographic absence of inflammation
Time Frame
12 months after the intervention
Title
Pulpotomy success
Description
clinical and radiographic absence of inflammation
Time Frame
18 months after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients age between 20 and 40 years old.
Teeth diagnosed with symptomatic irreversible pulpitis.
Normal periapical condition confirmed by normal periapical radiograph or that with minimal widening of the PDL space.
The teeth are restorable.
Teeth probing depth and mobility should be within normal limits.
Exclusion Criteria:
Teeth with immature roots
Non restorable teeth
Bleeding could not be controlled after pulpotomy in 10 minutes.
Medically compromised patients with systemic complication that would alter the treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdel Rahman m Hashem, phd
Phone
226401884
Email
ahmed@endohashem.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdel Rahman Hashem, phd
Phone
226401884
Email
ahmed@endohashem.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdel Rahman Hashem, phd
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shehabeldin m saber, prof
Phone
+201001413734
Email
saberse@asfd.asu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32553879
Citation
Haikal L, Ferraz Dos Santos B, Vu DD, Braniste M, Dabbagh B. Biodentine Pulpotomies on Permanent Traumatized Teeth with Complicated Crown Fractures. J Endod. 2020 Sep;46(9):1204-1209. doi: 10.1016/j.joen.2020.06.003. Epub 2020 Jun 15.
Results Reference
result
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Evaluation of Post Operative Pain and Success Rate After Pulpotomy
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