Dental Caries, Dental Pulp Exposure
Conditions
Keywords
pediatrics, dental caries, dental pulp exposure, incisor
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.
Interventions
PROCEDURERCT Group
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.
PROCEDUREMTA/FS pulpotomy Group
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.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Canada
Participant flow
Recruitment details
Subjects were recruited at The Hospital for Sick Children between September 2010 and September 2012.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 30 |
| Total | 70 |
Baseline characteristics
| Characteristic | MTA/FS Pulpotomy Group | RCT Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 40 Participants | 30 Participants | 70 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Incisors | 100 incisors | 72 incisors | 172 incisors |
| Region of Enrollment Canada | 40 participants | 30 participants | 70 participants |
| Sex: Female, Male Female | 21 Participants | 16 Participants | 37 Participants |
| Sex: Female, Male Male | 19 Participants | 14 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 30 |
| serious Total, serious adverse events | 0 / 40 | 0 / 30 |
Outcome results
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.
Time frame: 12 months after the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MTA/FS Pulpotomy Group | Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure. | .97 Proportion of incisors |
| RCT Group | Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure. | .92 Proportion of incisors |
Comparison: Radiographic outcomes were compared using univariate repeated measures logistic regression. A binary logistic generalized estimating equation model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups.p-value: 0.1595% CI: [0.08, 1.49]Chi-squared
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.
Time frame: 18 months after the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MTA/FS Pulpotomy Group | Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcomes 18 Months Post-procedure. | .93 Proportion of incisors |
| RCT Group | Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcomes 18 Months Post-procedure. | .92 Proportion of incisors |
Comparison: Radiographic outcomes were compared using univariate repeated measures logistic regression. A binary logistic generalized estimating equation model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups.p-value: 0.3895% CI: [0.19, 1.89]Chi-squared
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.
Time frame: 12 months after the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MTA/FS Pulpotomy Group | Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-procedure. | .98 Proportion of incisors |
| RCT Group | Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-procedure. | 1.0 Proportion of incisors |
Comparison: A binary logistic generalized estimating equation (GEE) model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups for radiographic and clinical outcomes.p-value: 0.51Fisher Exact
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.
Time frame: 18 months after the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MTA/FS Pulpotomy Group | Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 18 Months Post-procedure. | .97 Proportion of incisors |
| RCT Group | Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 18 Months Post-procedure. | .98 Proportion of incisors |
Comparison: A binary logistic generalized estimating equation (GEE) model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups for radiographic and clinical outcomes.p-value: 0.64Fisher Exact
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.
Time frame: 12 and 18 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MTA/FS Pulpotomy Group | MTA/FS Pulpotomy and RCT Treated Incisor Survival | Survival at 12 months | 1 Proportion of participants |
| MTA/FS Pulpotomy Group | MTA/FS Pulpotomy and RCT Treated Incisor Survival | Survival at 18 months | .94 Proportion of participants |
| RCT Group | MTA/FS Pulpotomy and RCT Treated Incisor Survival | Survival at 12 months | .97 Proportion of participants |
| RCT Group | MTA/FS Pulpotomy and RCT Treated Incisor Survival | Survival at 18 months | .97 Proportion of participants |
p-value: 0.11Log Rank