MTA/FS Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial

The Hospital for Sick Children

Status and phase: Completed; Phase 2

Conditions: Dental Caries; Dental Pulp Exposure

Treatments: Procedure: RCT Group; Procedure: MTA/FS pulpotomy Group

Study type: Interventional

Funder types: Other

Identifiers

NCT02019563

1000019443

Details and patient eligibility

About

To compare radiographic and clinical outcomes and survival of mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy and root canal therapy (RCT) in carious vital primary maxillary incisors.

Full description

Dental caries is the most common chronic disease in children. Caries of the primary maxillary incisors is common in young children; often necessitating either extraction or pulp therapy. The premature loss of primary maxillary incisors can adversely affect a child's dental occlusion, ability to properly size food boluses for swallowing, speech articulation, facial esthetics and psychosocial development. Pulp treatment of cariously exposed vital primary incisors may prevent premature tooth loss as well as eliminate pain. Currently, there is a paucity of outcome investigations with regard to pulp therapy in primary incisors.

Enrollment: 70 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• children with one or more carious primary maxillary incisors where removal of dental caries will likely to produce a vital pulp exposure
• reside in the GTA at time of inclusion
• English-speaking

Exclusion criteria

• history of spontaneous or lingering stimulated pain, swelling, fistula or sinus tract, tenderness to percussion and pathological mobility
• incisors with preoperative radiographic evidence of periapical or periradicular radiolucency, a widened periodontal ligament space, physiological resorption, incomplete root formation, internal or external root resorption, pulp canal obliteration or pulp calcifications
• non-restorable tooth

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

MTA/FS pulpotomy Group

Experimental group

Description:

Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).

Treatment:

Procedure: MTA/FS pulpotomy Group

RCT Group

Active Comparator group

Description:

Children randomized to this group will undergo the root canal therapy (RCT) technique.

Treatment:

Procedure: RCT Group