Biodentine Versus White MTA Pulpotomy

University Ghent

Status and phase: Completed; Phase 3

Conditions: Extensive Decay in Primary Molars

Treatments: Drug: Tempophore pulpotomy; Drug: Biodentine pulpotomy; Drug: White MTA pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01733420

2011/538

Details and patient eligibility

About

A clinical trial to evaluate and compare three different products used for endodontic treatment (taking the infected nerve out of the teeth) of primary teeth.

Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the former iodoform product.

Enrollment: 120 patients

Sex: All

Ages: 2 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients (Children with carious deciduous molars indicated for pulpotomy) belonging to the category of ASA I according to the 'American Society of Anaesthesiologists'.
• Patients without any known medical history of systemic complications contradicting pulp treatment.
• Patients are indicated for treatment under general anaesthesia due to polycaries / fear / anxiety / very young age.
• Written consent is obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Biodentine

Experimental group

Description:

Pulpotomy using Biodentine as pulpotomy medicine.

Treatment:

Drug: Biodentine pulpotomy

White Mineral trioxide Aggregate (MTA)

Active Comparator group

Description:

Pulpotomy using white MTA as pulpotomy medicine.

Treatment:

Drug: White MTA pulpotomy

Tempophore

Active Comparator group

Description:

Pulpotomy using Tempophore as pulpotomy medicine in a control group.

Treatment:

Drug: Tempophore pulpotomy