Clinical trial NCT02019563: MTA/FS Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial
Official title: Mineral Trioxide Aggregate/Ferric Sulfate Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Caries
Dental Pulp Exposure
Keywords: pediatrics
dental caries
dental pulp exposure
incisor
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure.
timeFrame: 12 months after the procedure
measure: Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcomes 18 Months Post-procedure.
timeFrame: 18 months after the procedure
Secondary outcomes:
measure: Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-procedure.
timeFrame: 12 months after the procedure
measure: Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 18 Months Post-procedure.
timeFrame: 18 months after the procedure
measure: MTA/FS Pulpotomy and RCT Treated Incisor Survival
timeFrame: 12 and 18 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Peter Judd, DDS
role: PRINCIPAL_INVESTIGATOR
References: