Clinical trial NCT05747300: Wellroot PT Versus MTA in Pulpotomy of Primary Molars
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulpotomy
Keywords: Pulpotomy wellroot PT bioceramic paste
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 24
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative pain
timeFrame: 1 year
measure: Soft tissue pathology
timeFrame: 1 year
measure: Pain to percussion
timeFrame: 1 year
measure: Pathologic mobility
timeFrame: 1 year
Secondary outcomes:
measure: Absence of furcation or periapical radiolucency Absence of external or internal root resorption
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: