Back to resultsConservative Pulp Therapy of Primary Molars Using TheraCAL
Primary Purpose
Reversible Pulpitis
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Dual cured resin modified tricalcium silicate cement
Sponsored by
About this trial
This is an interventional treatment trial for Reversible Pulpitis focused on measuring indirect pulp capping, direct pulp capping, partial pulpotomy, pulpotomy, TheraCal, primary molars
Eligibility Criteria
Inclusion Criteria:
- Four to six years old healthy children
- Cooperative (frankle scale + and ++)
- With at least one vital and restorable primary molar with deep caries.
Exclusion Criteria:
- History of spontaneous pain, swelling, or sinus tract
- Pathological mobility
- pain on percussion
- Furcation or periapical radiolucency
- Internal or external pathological root resorption
- Widening of periodontal membrane space
- Discontinuity of lamina dura.
Sites / Locations
- Faculty of Dentistry, Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
indirect pulp capping
Direct pulp Capping
Partial Pulpotomy
pulpotomy
Arm Description
TheraCAL PT will be applied to affected dentin covering the pup.
TheraCAL PT will be applied to pinpoint pulp exposures surrounded by sound dentin.
Pulp exposure will be enlarged to a depth of 1-3 mm by a sterile round diamond bur, and then TheraCAL PT will applied after hemostasis.
complete removal of coronal pulp tissue will be attempted if bleeding persisted after attempting Partial pulpotomy for exposures that are not eligible for DPC. TheraCAL PT will be applied thereafter, after achieving hemostasis.
Outcomes
Primary Outcome Measures
Changes in Visual and tactile clinical examination
Teeth will examined for any clinical signs of irreversible pulpitis or pulp necrosis
Secondary Outcome Measures
Change in Dental Periapical Radiographic examination
Teeth will be examined for any radiographic signs of pulp necrosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04167943
Brief Title
Conservative Pulp Therapy of Primary Molars Using TheraCAL
Official Title
Indirect Pulp Capping, Direct Pulp Capping, Partial Pulpotomy, Pulpotomy of Primary Molars Using TheraCal; A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)
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
5. Study Description
Brief Summary
The study is a clinical trial that assesses the clinical and radiographic success rates of 3 conservative pulp therapy treatments in primary molars compared to conventional pulpotomy using a bioactive dual cured calcium silicate cement (TheraCAL PT).
Detailed Description
Participating Children will be recruited from the outpatient's clinic of pediatric dentistry department , Faculty of Dentistry Ain Shams University and will be allocated to one of the following groups; Indirect pulp capping, direct pulp capping, partial pulpotomy or pulpotomy. TheraCAL PT, a dual cured tricalcium silicate cement will be used in all groups as the pulp capping material. Children will be followed every 6 months for a period of 1 year to evaluate clinical and radiographic success.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reversible Pulpitis
Keywords
indirect pulp capping, direct pulp capping, partial pulpotomy, pulpotomy, TheraCal, primary molars
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
indirect pulp capping
Arm Type
Experimental
Arm Description
TheraCAL PT will be applied to affected dentin covering the pup.
Arm Title
Direct pulp Capping
Arm Type
Experimental
Arm Description
TheraCAL PT will be applied to pinpoint pulp exposures surrounded by sound dentin.
Arm Title
Partial Pulpotomy
Arm Type
Experimental
Arm Description
Pulp exposure will be enlarged to a depth of 1-3 mm by a sterile round diamond bur, and then TheraCAL PT will applied after hemostasis.
Arm Title
pulpotomy
Arm Type
Experimental
Arm Description
complete removal of coronal pulp tissue will be attempted if bleeding persisted after attempting Partial pulpotomy for exposures that are not eligible for DPC. TheraCAL PT will be applied thereafter, after achieving hemostasis.
Intervention Type
Drug
Intervention Name(s)
Dual cured resin modified tricalcium silicate cement
Other Intervention Name(s)
TheraCal PT
Intervention Description
A resin based, dual cured tricalcium silicate based cement
Primary Outcome Measure Information:
Title
Changes in Visual and tactile clinical examination
Description
Teeth will examined for any clinical signs of irreversible pulpitis or pulp necrosis
Time Frame
every 6 months
Secondary Outcome Measure Information:
Title
Change in Dental Periapical Radiographic examination
Description
Teeth will be examined for any radiographic signs of pulp necrosis
Time Frame
every 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Four to six years old healthy children
Cooperative (frankle scale + and ++)
With at least one vital and restorable primary molar with deep caries.
Exclusion Criteria:
History of spontaneous pain, swelling, or sinus tract
Pathological mobility
pain on percussion
Furcation or periapical radiolucency
Internal or external pathological root resorption
Widening of periodontal membrane space
Discontinuity of lamina dura.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariem Wassel
Organizational Affiliation
Faculty of Dentistry, Ain Sham University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Ain Shams University
City
Cairo
ZIP/Postal Code
1156
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Conservative Pulp Therapy of Primary Molars Using TheraCAL
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