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A randomized clinical trial that aims to evaluate clinical and radiographic success rates of indirect pulp capping and direct pulp capping in primary molars with reversible pulpitis using a light-cured tri-calcium silicate base material (TheraCal (LC)).
Participating primary molars will be randomly allocated to one of the following groups: Indirect pulp capping group or Direct pulp capping group. A light-cured tri-calcium silicate base material (TheraCal (LC) ) will be used in the two groups as a dressing material. Patients will be recruited from the outpatient clinic of the pediatric dentistry department, Faculty of Dentistry Ain Shams University. The participant will be recalled for follow-up assessments at 3, 6,9, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indirect Pulp Capping | Experimental | TheraCal (LC) will be applied to affected dentin after excavation of infected dentin |
|
| Direct Pulp Capping | Experimental | TheraCal (LC) will be applied to pinpoint pulp exposures (less than 1mm ) in vital pulps surrounded by sound dentin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light cured tri-calcium silicate base material | Drug | TheraCal (LC) (BISCO Inc., Schamburg, IL, USA) was introduced in (2011), are available commercially as flowable cement applicable via syringe |
| Measure | Description | Time Frame |
|---|---|---|
| recording signs and symptoms through clinical examination | All the primary molars participating in this study will be examined clinically under the illumination of dental unit, percussion and palpation test will be performed to ensure absence of any sign and symptoms of irreversible pulpitis or nectrotic pulp during follow -up period. | one year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| recording pathological Changes in Radiographic examination | All the primary molars participating in this study will be examined radiographically every (3,6,9,12 months) to ensure the absence of any pathological changes . | one year follow-up |
| Evaluation of TheraCal (LC) as a pulp capping material |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yomna Hussein Moselhy, M.Sc. | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Faculy of Dentistry | Cairo | 02112 | Egypt | |||
| Department of pediatric dentistry - Ain Shams University |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C000632580 | TheraCal |
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Simple parallel randomization was performed by using computerized random numbers
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The participants and the outcome assessor were blinded. The primary investigator blinding was impossible
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Clinical and radiographic examination will be done to each tooth participating in this study to evaluate the efficiency of TheraCal (LC) when used as a pulp capping material in primary molars . |
| one year follow-up |
| Cairo |
| 02112 |
| Egypt |
| Outpatient Clinic of the Department of Pediatric Dentistry, Ain Shams University | Cairo | 11566 | Egypt |