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Clinical Trials/NCT05747300
NCT05747300
Not yet recruiting
Not Applicable

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

Cairo University0 sites24 target enrollmentMarch 2023
ConditionsPulpotomy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulpotomy
Sponsor
Cairo University
Enrollment
24
Primary Endpoint
Pain to percussion
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 2023
End Date
December 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Doaa Gamal

Doaa Gamal Mohamed

Cairo University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Pain to percussion

Time Frame: 1 year

Binary (present/absent) Percussion test by the back of the dental mirror

Soft tissue pathology

Time Frame: 1 year

Binary (present/absent) Visual clinical examination

Pathologic mobility

Time Frame: 1 year

Binary (present/absent) Mobility test (pressure using the end of two dental mirrors)

Post-operative pain

Time Frame: 1 year

Binary (present/absent) Verbal question to patient/ parent

Secondary Outcomes

  • Absence of furcation or periapical radiolucency Absence of external or internal root resorption(1 year)

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