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Evaluate clinically and radiographically the effect of biodentine and hyaluronic acid (HA) versus formocresol (FC) as pulpotomy medications in primary molars.
Split mouth randomized controlled clinical trial. This study will be conducted on 96 teeth from 48 children in age group 4-7 years and have bilateral lower primary molars indicated for vital pulpotomy procedure. for:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control: Formocresol | Active Comparator | Teeth will be treated by using squeezed sterile cotton pellet with 20% formcresol for 1 minute then removed and pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste. |
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| Group A : (Biodentine) | Experimental | The biodentine mix will be prepared according to the manufacturer's instructions and condensed lightly with a condenser on the pulp stumps, and allowed to set. |
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| Group B : (Hyaluronic acid gel) | Experimental | Hyaluronic acid gel will be compressed against the amputated pulp for 5 minutes. Then the pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formocresol | Drug | Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.Teeth will be treated by using squeezed sterile cotton pellet with 20% formcresol for 1 minute |
| Measure | Description | Time Frame |
|---|---|---|
| clinically successful pulpotomy |
| 18 months |
| radiographically successful pulpotomy |
| 18 months |
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Inclusion Criteria:
-Clinical criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weaam I El-tantawy | assistant lecturer ,Faculty of Dentistry, Mansoura University B.D.S (2016) | Principal Investigator |
| Nadia M Farrag | Professor ,Faculty of Dentistry, Mansoura University | Study Director |
| Hossam E Hammouda | Lecturer, Faculty of Dentistry, Mansoura University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dentistry | Al Mansurah | 35511 | Egypt |
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| ID | Term |
|---|---|
| C031025 | formocresol |
| C506393 | tricalcium silicate |
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the observer and the recipients will be blinded to the study group to avoid bias (double blind randomized controlled trial)
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| Biodentine | Drug | Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.The biodentine mix will be prepared according to the manufacturer's instructions and condensed lightly with a condenser on the pulp stumps |
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| Hyaluronic acid gel | Drug | Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.Hyaluronic acid gel will be compressed against the amputated pulp for 5 minutes. |
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