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

Study Overview
=================
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.

Official Title
-----------------
Mineral Trioxide Aggregate/Ferric Sulfate Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial

Conditions
-----------------
Dental Caries, Dental Pulp Exposure

Intervention / Treatment
-----------------
* Procedure: RCT Group
* Procedure: MTA/FS pulpotomy Group


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MTA/FS pulpotomy Group<br>Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS). | Procedure: MTA/FS pulpotomy Group<br>* After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface.<br>|
| Active Comparator: RCT Group<br>Children randomized to this group will undergo the root canal therapy (RCT) technique. | Procedure: RCT Group<br>* After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-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. | 12 months after the procedure | 
| Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcomes 18 Months Post-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. | 18 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-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. | 12 months after the procedure | 
| Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 18 Months Post-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. | 18 months after the procedure | 
| MTA/FS Pulpotomy and RCT Treated Incisor Survival | 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. | 12 and 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatrics, dental caries, dental pulp exposure, incisor