Wellroot PT Versus MTA in Pulpotomy of Primary Molars

Not Applicable

Not yet recruiting

• Conditions: Pulpotomy
• Interventions: Other: Premixed bioceramic paste wellroot PT

• Registration Number: NCT05747300
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-02-17
• Last Update Submitted: 2023-02-17
• Study First Posted: 2023-02-28
• Last Update Posted: 2023-02-28
• Study Start: 2023-03
• Primary Completion: 2024-03
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MTA pulpotomy	Premixed bioceramic paste wellroot PT	Vital pulpotomy primary Molars using MTA
Wellroot PT pulpotomy	Premixed bioceramic paste wellroot PT	Vital pulpotomy primary Molars using premixed bioceramic paste wellroot PT

Primary Outcome Measures

Name	Time	Method
Pain to percussion	1 year	Binary (present/absent) Percussion test by the back of the dental mirror
Soft tissue pathology	1 year	Binary (present/absent) Visual clinical examination
Pathologic mobility	1 year	Binary (present/absent) Mobility test (pressure using the end of two dental mirrors)
Post-operative pain	1 year	Binary (present/absent) Verbal question to patient/ parent

Secondary Outcome Measures

Name	Time	Method
Absence of furcation or periapical radiolucency Absence of external or internal root resorption	1 year	Binary (present/absent) Intraoral digital periapical X-ray