Wellroot PT Versus MTA in Pulpotomy of Primary Molars

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05747300
Collaborator
(none)
24
2
21.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Premixed bioceramic paste wellroot PT
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Post-operative pain [1 year]

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

    2. Soft tissue pathology [1 year]

      Binary (present/absent) Visual clinical examination

    3. Pain to percussion [1 year]

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

    4. Pathologic mobility [1 year]

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

    Secondary Outcome Measures

    1. Absence of furcation or periapical radiolucency Absence of external or internal root resorption [1 year]

      Binary (present/absent) Intraoral digital periapical X-ray

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Doaa Gamal, Doaa Gamal Mohamed, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05747300
    Other Study ID Numbers:
    • Experimental
    First Posted:
    Feb 28, 2023
    Last Update Posted:
    Feb 28, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Doaa Gamal, Doaa Gamal Mohamed, Cairo University

    Study Results

    No Results Posted as of Feb 28, 2023