Wellroot PT Versus MTA in Pulpotomy of Primary Molars

Pulpotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05747300
• Other study ID #: Experimental
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpotomy

Intervention

Other:
• Premixed bioceramic paste wellroot PT
Vital pulpotomy primary Molars using premixed bioceramic paste wellrootPT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	Binary (present/absent) Verbal question to patient/ parent	1 year
Primary	Soft tissue pathology	Binary (present/absent) Visual clinical examination	1 year
Primary	Pain to percussion	Binary (present/absent) Percussion test by the back of the dental mirror	1 year
Primary	Pathologic mobility	Binary (present/absent) Mobility test (pressure using the end of two dental mirrors)	1 year
Secondary	Absence of furcation or periapical radiolucency Absence of external or internal root resorption	Binary (present/absent) Intraoral digital periapical X-ray	1 year