Clinical and Radiographic Success of MTA vs Biodentine

Part of paid clinical trials in Danville, Pennsylvania.

Sponsor
Geisinger Clinic
Study ID
NCT04863222
Phase
PHASE4
Status
Recruiting

Conditions

  • Indirect Pulp Cap
  • Pulpotomy

Eligibility Criteria

Sex
ALL
Age
2 Years - 12 Years
Healthy Volunteers
Accepted

Interventions

  • Biodentine — DEVICE
    During a patients procedure, one tooth will receive Biodentine instead of MTA.
  • mineral trioxide aggregate (MTA) — BIOLOGICAL
    mineral trioxide aggregate (MTA)

Study Details

The purpose of this prospective study is to compare the clinical and radiographic success of MTA and Biodentine as a medicament in vital pulp therapy in maxillary and mandibular primary molars in a pediatric population. There is limited research currently on Biodentine since it's a novel product. Biodentine is less expensive than MTA and does not cause discoloration like MTA. Biodentine may be an alternative medicament used for vital pulp therapy in primary molars.

Key Dates

Start date
Nov 12, 2021
Status verified
Dec 2025
Primary completion
Aug 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
646 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MTA, then Biodentine
    The participant will receive the standard of care procedure using MTA in on a right primary molar. A left primary molar will then be treated using Biodentine.
  • Experimental: Biodentine, then MTA
    Investigators will prepare and treat a participants right primary molar with Biodentine. The participant will then receive the standard of care procedure using MTA in on a left primary molar.

Primary Outcome Measure

Rate of clinical success in pulpotomies and indirect pulp caps [ Time Frame: 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
GeisingerDanvillePennsylvania17822
Gayatri Malik, DMD

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