Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars.
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
The aim of the study is to assess the effect of TheraCal PT pulpotomy versus MTA pulpotomy on the survival rate of cariously exposed vital primary molars.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
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 22, 2020
CompletedFirst Posted
Study publicly available on registry
November 5, 2020
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedMarch 4, 2022
March 1, 2022
3 months
October 22, 2020
March 2, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Survival rate (Absence of spontaneous pain)
Binary outcome measured with direct questioning to the patient
"3 months"
Survival rate (Absence of spontaneous pain)
Binary outcome measured with direct questioning to the patient
"6 months"
Survival rate (Absence of swelling)
Binary outcome measured visually by intraoral/extraoral examination
"3 months"
Survival rate (Absence of swelling)
Binary outcome measured visually by intraoral/extraoral examination
"6 months"
Secondary Outcomes (2)
Absence of periapical radiolucency or absence of internal/external root resorption
"6 months"
Time lapse till final restoration performed.
"During procedure".
Study Arms (2)
Mineral trioxide aggregate (MTA)
ACTIVE COMPARATORSurvival rate of cariously exposed vital primary molars using MTA+ Curamed (UI, Kwiatkowskiego 1, 37-450 Staleya Wola, Polka)
TheraCal PT
EXPERIMENTALSurvival rate of cariously exposed vital primary molars using TheraCal PT (BISCO Dental Products, Schamberg IL, U.S.A.)
Interventions
Survival rate using MTA in cariously exposed vital primary molars
Survival rate using TheraCal PT in cariously exposed vital primary molars
Eligibility Criteria
You may qualify if:
- Aged 4 to 7 years , in good general health and mentally free.
- The parents provided written informed consent.
- Cariously exposed primary molars with reversible pulpitis.
- Teeth should be vital.
- Restorable teeth.
- Hemostasis achieved after complete pulpotomy
You may not qualify if:
- With systemic disease.
- Physical or mental disability.
- Unable to attend follow-up visits.
- Refusal of participation.
- Previously accessed teeth.
- History of spontaneous or prolonged pain.
- Swelling, tenderness to percussion or palpation, or pathological mobility.
- Pre-operative radiographic pathology such as resorption(internal or external),per-radicular or furcation radiolucency.
- Haemorrhage control is unachievable after pulpotomy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 22, 2020
First Posted
November 5, 2020
Study Start
March 1, 2022
Primary Completion
June 1, 2022
Study Completion
November 1, 2022
Last Updated
March 4, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share