Wellroot PT Versus MTA in Pulpotomy of Primary Molars

Study Overview
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Brief Summary
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compare the clinical and radiographic success of mineral trioxide aggregate (MTA) versus premixed bioceramic paste (Wellroot PT) as pulpotomy medicaments in primary molars.

Detailed Description
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Preservation of primary dentition decreases the risk of developing any occlusal abnormalities caused by premature loss of primary teeth, which are considered natural space maintainers for the successor permanent teeth, therefore vital pulp therapy is of a big concern in the research field in pediatric dentistry . One of the most commonly used regenerative materials in pulpotomies is Mineral Trioxide Aggregate (MTA) which showed a high success rate clinically and radiographically when compared to other materials due to its biocompatibility, antibacterial properties and excellent sealing ability . However it has some drawbacks such as difficult manipulation and handling because it is supplied in powder and liquid form which need mixing. Mixing is operator dependant and may be not uniform if handled wrongly, technique sensitive, potential discoloration, and long setting time. Premixed bioceramics Well-Root™ PT (Vericom, Gangwon-Do, Korea) have been introduced into the market and present with desirable properties as a pulp capping agent. Owing to good handling characteristics, biocompatibility, odontogenic property and antibacterial action, the premixed bioceramic materials are recommended for procedures such as pulp capping, pulpotomy, perforation repair, root-end filling, and obturation.

Official Title
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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

Conditions
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Pulpotomy

Intervention / Treatment
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* Other: Premixed bioceramic paste wellroot PT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 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. Exclusion Criteria: • 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MTA pulpotomy<br>Vital pulpotomy primary Molars using MTA | Other: Premixed bioceramic paste wellroot PT<br>* Vital pulpotomy primary Molars using premixed bioceramic paste wellrootPT<br>* Other names: Wellroot PT;|
| Experimental: Wellroot PT pulpotomy<br>Vital pulpotomy primary Molars using premixed bioceramic paste wellroot PT | Other: Premixed bioceramic paste wellroot PT<br>* Vital pulpotomy primary Molars using premixed bioceramic paste wellrootPT<br>* Other names: Wellroot PT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of furcation or periapical radiolucency Absence of external or internal root resorption | Binary (present/absent) Intraoral digital periapical X-ray | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpotomy wellroot PT bioceramic paste