Primary Teeth, Pulpotomy
Conditions
Keywords
Clinical and Radiograph
Brief summary
Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months and 12 months.
Detailed description
Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months and 12 months. Regular recall and follow up will be performed for patients who has MTA or FS pulpotomies. Clinical and radiographic findings will be recorded.
Interventions
DEVICEMTA
Mineral Trioxide Aggregate grey paste
DRUGFerric Sulfate
Ferric Sulfate paste
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* ASA I,II * Primary Molars diagnosed with normal or reversible pulpitis with vital carious pulp exposures * Teeth that can have hemostasis can be achieved with pressure * No clinical symptoms * No radiographic signs of internal resorption or external root resorption
Exclusion criteria
* Primary Molars diagnosed with irreversible pulpitis or necrotic pulp * Teeth that can not achieve hemostasis * Teeth with abscess or fistula * Teeth that have radiographic signs of internal resorption or external resorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars | 1 year | At recall visits 6,9,12 months, blinded clinical examination will be completed by participating faculty members who are calibrated to clinical scaring criteria. Periapical radiographs will be taken and evaluated by 2 pediatric dentists and 1 endodontist, for presence of various pathologies. Scored based on the criteria established by Zurn and Seale 2008. Scores will be transferred to Microsoft Excel. The difference between the two materials will be analyzed using the Mann-Whiteney U test, chi-square test and Fisher's exact test. Intra- and inter-rater agreement will be measured for radiographic assessment using Cohen's kappa test |
Participant flow
Pre-assignment details
3-10 years old, deep caries, No radiographic signs of internal/external root resorption, No pathology change, no swelling or abscess.
Participants by arm
| Arm | Count |
|---|---|
| Mineral Trioxide Aggregate Subject with pulpotomy treated with MTA MTA paste (\< 1gm) will be placed on pulp orifice once for the life of the primary teeth
MTA: Mineral Trioxide Aggregate grey paste | 11 |
| Ferric Sulfate Subject with pulpotomy treated with FS FS paste (\<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth
Ferric Sulfate: Ferric Sulfate paste | 46 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 32 |
Baseline characteristics
| Characteristic | Ferric Sulfate | Total | Mineral Trioxide Aggregate |
|---|---|---|---|
| Age, Categorical <=18 years | 46 Participants | 57 Participants | 11 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 81.3 Months STANDARD_DEVIATION 19.9 | 78.5 Months STANDARD_DEVIATION 18.8 | 73.9 Months STANDARD_DEVIATION 16.9 |
| patient has deep caries | 46 Participants | 57 Participants | 11 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 17 Participants | 25 Participants | 8 Participants |
| Sex: Female, Male Male | 29 Participants | 32 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 46 |
| other Total, other adverse events | 0 / 11 | 0 / 46 |
| serious Total, serious adverse events | 0 / 11 | 0 / 46 |
Outcome results
Primary
Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars
At recall visits 6,9,12 months, blinded clinical examination will be completed by participating faculty members who are calibrated to clinical scaring criteria. Periapical radiographs will be taken and evaluated by 2 pediatric dentists and 1 endodontist, for presence of various pathologies. Scored based on the criteria established by Zurn and Seale 2008. Scores will be transferred to Microsoft Excel. The difference between the two materials will be analyzed using the Mann-Whiteney U test, chi-square test and Fisher's exact test. Intra- and inter-rater agreement will be measured for radiographic assessment using Cohen's kappa test
Time frame: 1 year
Population: The patients who came back for follow up for long term clinical and radiographic success.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Mineral Trioxide Aggregate | Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars | Clinical success | 7 tooth |
| Mineral Trioxide Aggregate | Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars | Clinical fail | 2 tooth |
| Ferric Sulfate | Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars | Clinical success | 11 tooth |
| Ferric Sulfate | Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars | Clinical fail | 4 tooth |
p-value: 0.808Chi-squared