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

T

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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