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Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol pulpotomy in primary molars.
sixty primary molars were either treated with Theracal LC or formocresol pulpotomy. Teeth were followed up clinicaly and radiographically for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theracal LC | Experimental | Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. |
|
| Formocresol | Active Comparator | Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theracal LC | Drug | pulpotomy |
| |
| Formocresol |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Examination | Number of participants with tooth mobility, restoration loss, gingival swelling/fistula, pain on percussion. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Examination | Number of participants showing teeth with inter-radicular bone resorption, periapical bone resorption, internal root resorption, external root resorption, widening of periodontal ligament space. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Ain Shams University | Cairo | 1156 | Egypt |
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| ID | Title | Description |
|---|---|---|
| FG000 | Theracal LC | Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Theracal LC: pulpotomy |
| FG001 | Formocresol | Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Formocresol: Pulpotomy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Theracal LC | Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Theracal LC: pulpotomy |
| BG001 | Formocresol |
| 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 | Clinical Examination | Number of participants with tooth mobility, restoration loss, gingival swelling/fistula, pain on percussion. | Posted | Count of Participants | Participants | 12 months |
|
12 months
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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 | Theracal LC | Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Theracal LC: pulpotomy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| internal resorption | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mariem Wassel | Faculty of Dentistry Ain Shams University | +2 0064871416 | mariem.wassel@dent.asu.edu.eg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2017 | Jul 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C031025 | formocresol |
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| Drug |
Pulpotomy |
|
Formocresol (1/5 th concentration) was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Formocresol: Pulpotomy |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| radiographic and clinical examinations | Number | participants |
|
|
|
| Secondary | Radiographic Examination | Number of participants showing teeth with inter-radicular bone resorption, periapical bone resorption, internal root resorption, external root resorption, widening of periodontal ligament space. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 3 |
| 30 |
| EG001 | Formocresol | Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Formocresol: Pulpotomy | 0 | 30 | 0 | 30 | 5 | 30 |
| interradicular bone resorption | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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