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

Phase 2

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
MTA/FS pulpotomy Group	MTA/FS pulpotomy Group	Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).
RCT Group	RCT Group	Children randomized to this group will undergo the root canal therapy (RCT) technique.

Primary Outcome Measures

Name	Time	Method
Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure.	12 months after the procedure	Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.
Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcomes 18 Months Post-procedure.	18 months after the procedure	Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.

Secondary Outcome Measures

Name	Time	Method
Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 18 Months Post-procedure.	18 months after the procedure	Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes.
MTA/FS Pulpotomy and RCT Treated Incisor Survival	12 and 18 months	Kaplan-Meier survival curves were generated for the MTA/FS pulpotomy and RCT treatment groups. One treated incisor was selected by random draw from each subject for survival analysis to preserve independence of observations. The log-rank test was used to statistically compare survival of incisors.
Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-procedure.	12 months after the procedure	Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes. Clinical outcomes between the MTA/FS pulpotomy and RCT groups were compared using Fisher's Exact test.