Conservative Pulp Therapy of Primary Molars Using TheraCAL
Indirect Pulp Capping, Direct Pulp Capping, Partial Pulpotomy, Pulpotomy of Primary Molars Using TheraCal; A Clinical Trial
1 other identifier
interventional
216
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2019
CompletedFirst Posted
Study publicly available on registry
November 19, 2019
CompletedStudy Start
First participant enrolled
November 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedJune 14, 2022
June 1, 2022
1.7 years
October 26, 2019
June 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Visual and tactile clinical examination
Teeth will examined for any clinical signs of irreversible pulpitis or pulp necrosis
every 6 months
Secondary Outcomes (1)
Change in Dental Periapical Radiographic examination
every 6 months
Study Arms (4)
indirect pulp capping
EXPERIMENTALTheraCAL PT will be applied to affected dentin covering the pup.
Direct pulp Capping
EXPERIMENTALTheraCAL PT will be applied to pinpoint pulp exposures surrounded by sound dentin.
Partial Pulpotomy
EXPERIMENTALPulp 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.
pulpotomy
EXPERIMENTALcomplete 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.
Interventions
A resin based, dual cured tricalcium silicate based cement
Eligibility Criteria
You may qualify if:
- Four to six years old healthy children
- Cooperative (frankle scale + and ++)
- With at least one vital and restorable primary molar with deep caries.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, Ain Shams University
Cairo, 1156, Egypt
Related Publications (1)
Wassel M, Hamdy D, Elghazawy R. Evaluation of four vital pulp therapies for primary molars using a dual-cured tricalcium silicate (TheraCal PT): one-year results of a non-randomized clinical trial. J Clin Pediatr Dent. 2023 Mar;47(2):10-22. doi: 10.22514/jocpd.2023.004. Epub 2023 Mar 3.
PMID: 36890738DERIVED
Study Officials
- STUDY DIRECTOR
Mariem Wassel
Faculty of Dentistry, Ain Sham University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of pediatric dentistry
Study Record Dates
First Submitted
October 26, 2019
First Posted
November 19, 2019
Study Start
November 25, 2019
Primary Completion
August 1, 2021
Study Completion
September 1, 2021
Last Updated
June 14, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share