Wellroot PT Versus MTA in Pulpotomy of Primary Molars

NCT ID: NCT05747300

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2024-12-31

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.

Conditions

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Pulpotomy

Keywords

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Pulpotomy wellroot PT bioceramic paste

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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MTA pulpotomy

Vital pulpotomy primary Molars using MTA

Group Type ACTIVE_COMPARATOR

Premixed bioceramic paste wellroot PT

Intervention Type OTHER

Vital pulpotomy primary Molars using premixed bioceramic paste wellrootPT

Wellroot PT pulpotomy

Vital pulpotomy primary Molars using premixed bioceramic paste wellroot PT

Group Type EXPERIMENTAL

Premixed bioceramic paste wellroot PT

Intervention Type OTHER

Vital pulpotomy primary Molars using premixed bioceramic paste wellrootPT

Interventions

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Premixed bioceramic paste wellroot PT

Vital pulpotomy primary Molars using premixed bioceramic paste wellrootPT

Intervention Type OTHER

Other Intervention Names

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Wellroot PT

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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Doaa Gamal

Doaa Gamal Mohamed

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Experimental

Identifier Type: -

Identifier Source: org_study_id