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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MTA/FS pulpotomy Group | Experimental | Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS). |
|
| RCT Group | Active Comparator | Children randomized to this group will undergo the root canal therapy (RCT) technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RCT Group | Procedure | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Judd, DDS | The Hospital for Sick Children, Toronto Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
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Subjects were recruited at The Hospital for Sick Children between September 2010 and September 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: 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. |
| FG001 | RCT Group | Children randomized to this group will undergo the root canal therapy (RCT) technique. Root canal therapy (RCT): 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The MTA/FS group consisted of 100 incisors in 40 subjects (19 males; 21 females) and the RCT group consisted of 72 primary incisors in 30 subjects (14 males; 16 females).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Proportion of incisors | 12 months after the procedure | Incisors | Participants |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: 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. |
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Limitations of the study design included no blinding of personnel providing treatment or raters assessing clinical and radiographic outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trang Nguyen | The Hospital for Sick Children | 6473300825 | trang.nguyen@easternhealth.ca |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D003789 | Dental Pulp Exposure |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D003788 | Dental Pulp Diseases |
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| MTA/FS pulpotomy Group | Procedure | 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. |
|
| 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 |
| BG001 | RCT Group | Children randomized to this group will undergo the root canal therapy (RCT) technique. Root canal therapy (RCT): 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Incisors | Number | incisors |
|
| OG001 | RCT Group | Children randomized to this group will undergo the root canal therapy (RCT) technique. Root canal therapy (RCT): 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. |
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| Primary | 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. | Posted | Number | Proportion of incisors | 18 months after the procedure | Incisors | Participants |
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| Secondary | 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. | Posted | Number | Proportion of incisors | 12 months after the procedure | Incisors | Participants |
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| Secondary | 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. | Posted | Number | Proportion of incisors | 18 months after the procedure | Incisors | Participants |
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| Secondary | 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. | Four participants in the MTA/FS and two participants in the RCT group did not have data collected due to lost to follow-up. Remaining participants were censored if lost to follow-up, exfoliated, lost to trauma or had a non-occurrence of a failure before the trial end. | Posted | Number | Proportion of participants | 12 and 18 months |
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| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | RCT Group | Children randomized to this group will undergo the root canal therapy (RCT) technique. Root canal therapy (RCT): 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. | 0 | 30 | 0 | 30 |
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