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| ID | Type | Description | Link |
|---|---|---|---|
| 20240457 . | Other Grant/Funding Number | Jordan University of Science and Technology |
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| Name | Class |
|---|---|
| Jordan University of Science and Technology | OTHER |
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The aim of this study is to compare the clinical and radiographic outcomes of selective versus nonselective caries removal in MIH affected teeth with deep carious lesions using enhanced clinical protocols.
The aim of this study is to compare the clinical and radiographic outcomes of selective versus nonselective caries removal in MIH affected teeth with deep carious lesions using enhanced clinical protocols.Cases will be collected from the undergraduate and postgraduate clinics over a 6 months' period according to predetermined inclusion criteria. Preoperative clinical and radiographic assessment will be conducted to MIH affected molars. MIH molars with deep caries (assymptomatic/ with symptoms of reversible pulpitis) will be randomly allocated for the choice of treatment with selective or non -selective caries excavation. Randomization of teeth between the 2 treatment groups will be performed using an online block randomization technique (block of 6) with the tooth as unit of randomization. Time taken for each procedure will be recorded by the research assistant each visit prospectively after achieving local anaesthesia till the end of procedure. Patients will be asked to rate their satisfaction with the received treatment on the end of treatment visit using a designed questionnaire. Clinical and radiographic success, and patient satisfaction will be evaluated at 6 and 12 months follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selective caries removal | Experimental | Selective carious removal to firm dentine. Subsequently, 2 mm of Biodentine will be placed as a liner over the pulpal wall leaving the peripheries of the cavity available for bonding of the subsequent restoration. |
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| Non-Selective caries removal | Experimental | Complete caries excavation will be done to hard scratchy dentine, with the aid of caries detector dye.If no pulp exposure is evident 2 mm of Biodentine will be placed and the cavity will be restored. If pulp exposure occurred, and it is bleeding normally and uniformly red with no zones of degeneration or necrosis then direct pulp capping will be attempted with Biodentine as a capping material. If no hemostasis is achieved, then the procedure will be modified to either partial pulpotomy, full pulpotomy or RCT depending on the clinical assessment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective caries removal | Procedure | Selective carious removal to firm dentine. Subsequently, 2 mm of Biodentine will be placed as a liner over the pulpal wall leaving the peripheries of the cavity available for bonding of the subsequent restoration. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Radiographic Success | No radiographic evidence of periapical changes indicative of apical periodontitis | 6,12 months |
| Rate of Clinical Success | Absence of clinical symptoms of spontaneous pain, pain on percussion, pathologic mobility or abscess formation.,assessed through taking pain history and clinical examination. | 6,12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient acceptance of treatment | Self-reported child acceptance using questionnaire | immediately following intervention, and at 6 and 12 months recall |
| Time taken for intervention | Time taken to perform intervention in minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University of Science and Technology | Irbid | Jordan |
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| ID | Term |
|---|---|
| D000094604 | Molar Hypomineralization |
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
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| Non-Selective caries removal | Procedure | Complete caries excavation will be done to hard scratchy dentine, with the aid of caries detector dye.If no pulp exposure is evident 2 mm of Biodentine will be placed and the cavity will be restored. If pulp exposure occurred, and it is bleeding normally and uniformly red with no zones of degeneration or necrosis then direct pulp capping will be attempted with Biodentine as a capping material. If no hemostasis is achieved, then the procedure will be modified to either partial pulpotomy, full pulpotomy or RCT depending on the clinical assessment. |
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| Perioperative/Periprocedural: from the time the child sits on the dental chair and until the intervention is completed. |
| Child pain score | Self-reported Child pain score preoperatively and one week after intervention, recorded on a scale of 0-10. | preoperatively and one week following the intervention |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017001 | Tooth Demineralization |