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pulpotomy will be done I primary molars with occlusal or proximal decay and level of cytokines will be measured as an indicator for pulp inflammation levels
The proposed trial interventions, pulpotomy, will follow standard clinical procedural guidelines. Participants will be allocated to one of the two intervention groups only after intra-operative confirmation of pulp vitality and achievement of radicular pulp hemostasis.
Standard clinical protocol for both groups with occlusal and proximal decay:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| occlusal decay | Experimental | Primary molars diagnosed with reversible pulpits caused by occlusal decay |
|
| Proximal decay | Active Comparator | Primary molars diagnosed with reversible pulpits caused by Proximal decay. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulpotomy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post operative Pain | The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10). | pain will be measured at one week , 3 months , 6 months and 12 months. |
| Preapical lesion | by Clinical examination: presence of Swelling, sinus tract, or fistula: ,(binary outcome: present or absent ) | will be measured at 3 months , 6 months and 12 months |
| Pain on percussion | Tapping the tooth with the blunt end of the mirror binary outcome: present or absent | will be measured at 3 months , 6 months and 12 months |
| Mobility | using Miller's mobility test :involves holding the tooth firmly between two instruments and assessing its mobility on a scale from 0 to 3. A score of 0 indicates no detectable movement, while scores of 1-3 represent increasing degrees of mobility. it will be measured as present for any score from 1 to 3 (binary: present or absent) | will be measured at 3 months , 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| radiographic success | using Digital periapical intraoral radiograph Radiographic Success: • Radiolucency at the furcation or periapical area, internal or external root resorption, will be examined (present or not) through digital periapical radiographs. Criteria for radiographic success
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasmin Ma Khalifa, PhD Candidate | Contact | +201000300634 | Ymkhalifa1991@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hany Saber | Professor of Pediatric Dentistry, Faculty of dentistry, Cairo Univeristy | Study Chair |
| Maii Mohammed | lecturer of Pediatric Dentistry, Faculty of dentistry, Cairo Univeristy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo Univeristy | Cairo | Egypt |
|
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| Measuring Cytokines level | Other | measuring cytokines level as an indicator for pulp inflammation |
|
| baseline data at the first visit following the procedure completion and at 6 and 12 months |
| Cytokines level | blood sample will be collected from exposed pulp chamber before removal and IL-8 & IL-10 levels will be measured using Enzyme-linked immunoassay ( ELISA) kit. unit of measurement: ng/L | at the time of pulpotomy procedure |
| Yasmin Magdi Khalifa | Principal Investigator |
| ID | Term |
|---|---|
| D011672 | Pulpotomy |
| ID | Term |
|---|---|
| D004708 | Endodontics |
| D003813 | Dentistry |
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