An interventional study of MTA and Ferric Sulfate in Primary Teeth and Pulpotomy, sponsored by Loma Linda University. Terminated. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment
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.
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.
Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject with pulpotomy treated with MTA MTA paste (\< 1gm) will be placed on pulp orifice once for the life of the primary teeth
Device: MTA
Subject with pulpotomy treated with FS FS paste (\<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth
Drug: Ferric Sulfate
Mineral Trioxide Aggregate grey paste
Ferric Sulfate paste
Also known as: FS
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
| Milestone | Mineral Trioxide Aggregate | Ferric Sulfate |
|---|---|---|
| Started | 11 | 46 |
| Completed | 8 | 14 |
| Not completed | 3 | 32 |
| Withdrew: Lost to follow-up | 3 | 32 |
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
| tooth | Mineral Trioxide Aggregate | Ferric Sulfate |
|---|---|---|
| Clinical success | 7 | 11 |
| Clinical fail | 2 | 4 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mineral Trioxide Aggregate | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Ferric Sulfate | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
some participants has more than one tooth needs pulpotomy treatment
| Age, Categorical(Participants) | Mineral Trioxide Aggregate | Ferric Sulfate | Total |
|---|---|---|---|
| <=18 years | 11 | 46 | 57 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Months) | Mineral Trioxide Aggregate | Ferric Sulfate | Total |
|---|---|---|---|
| Mean | 73.9 ± 16.9 | 81.3 ± 19.9 | 78.5 ± 18.8 |
| Sex: Female, Male(Participants) | Mineral Trioxide Aggregate | Ferric Sulfate | Total |
|---|---|---|---|
| Female | 8 | 17 | 25 |
| Male | 3 | 29 | 32 |
| Race and Ethnicity Not Collected(Participants) | Mineral Trioxide Aggregate | Ferric Sulfate | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| patient has deep caries(Participants) | Mineral Trioxide Aggregate | Ferric Sulfate | Total |
|---|---|---|---|
| Count of participants | 11 | 46 | 57 |
No study locations are listed for this record.
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Plan to share: No
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