Wellroot PT Versus MTA in Pulpotomy of Primary Molars
Clinical and Radiographic Evaluation of Premixed Bioceramic Paste (Wellroot PT) Versus Mineral Trioxide Aggregate (MTA) in Pulpotomy of Primary Molars: A Randomized Clinical Pilot Study
1 other identifier
interventional
24
0 countries
N/A
Brief Summary
compare the clinical and radiographic success of mineral trioxide aggregate (MTA) versus premixed bioceramic paste (Wellroot PT) as pulpotomy medicaments in 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 2023
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
February 17, 2023
CompletedFirst Posted
Study publicly available on registry
February 28, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedFebruary 28, 2023
February 1, 2023
1 year
February 17, 2023
February 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Post-operative pain
Binary (present/absent) Verbal question to patient/ parent
1 year
Soft tissue pathology
Binary (present/absent) Visual clinical examination
1 year
Pain to percussion
Binary (present/absent) Percussion test by the back of the dental mirror
1 year
Pathologic mobility
Binary (present/absent) Mobility test (pressure using the end of two dental mirrors)
1 year
Secondary Outcomes (1)
Absence of furcation or periapical radiolucency Absence of external or internal root resorption
1 year
Study Arms (2)
MTA pulpotomy
ACTIVE COMPARATORVital pulpotomy primary Molars using MTA
Wellroot PT pulpotomy
EXPERIMENTALVital pulpotomy primary Molars using premixed bioceramic paste wellroot PT
Interventions
Vital pulpotomy primary Molars using premixed bioceramic paste wellrootPT
Eligibility Criteria
You may qualify if:
- Children aged between 4 years and 7 years.
- Mandibular second primary molar with deep caries involving pulp.
- No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of the vestibule.
- Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.
- Radiographic criteria:
- No sign of radiolucency in periapical or furcation area.
- No widening of PDL space or loss of lamina dura continuity.
- No evidence of internal/external pathologic root resorption.
You may not qualify if:
- Uncooperative children.
- Children with systemic disease.
- Lack of informed consent by the child patient's parent.
- Unable to attend follow-up visits.
- Refusal of participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doaa Gamal Mohamed
Study Record Dates
First Submitted
February 17, 2023
First Posted
February 28, 2023
Study Start
March 1, 2023
Primary Completion
March 1, 2024
Study Completion
December 1, 2024
Last Updated
February 28, 2023
Record last verified: 2023-02