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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pulpotomy
• Intervention / Treatment: Other: Premixed bioceramic paste wellroot PT

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MTA pulpotomy; Vital pulpotomy primary Molars using MTA	Other: Premixed bioceramic paste wellroot PT; Vital pulpotomy primary Molars using premixed bioceramic paste wellrootPT; Other Names: Wellroot PT
Experimental: Wellroot PT pulpotomy; Vital pulpotomy primary Molars using premixed bioceramic paste wellroot PT	Other: Premixed bioceramic paste wellroot PT; Vital pulpotomy primary Molars using premixed bioceramic paste wellrootPT; Other Names: Wellroot PT

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Estimate): February 28, 2023

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Pulpotomy wellroot PT bioceramic paste
• Other Study ID Numbers: Experimental

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No