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| ID | Type | Description | Link |
|---|---|---|---|
| 20240506 | Other Grant/Funding Number | Jordan University of Science and Technology |
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This is a randomized clinical trial that aims to compare the clinical and radiographic success of Hall technique (HT) versus Indirect pulp capping (IPC) for the management of deep dentinal caries in primary molars and to compare the child and parent acceptance of HT versus IPC for the management of deep dentinal caries in primary molars.
This is a randomized clinical trial that aims to compare the clinical and radiographic success of Hall technique (HT) versus Indirect pulp capping (IPC) for the management of deep dentinal caries in primary molars and to compare the child and parent acceptance of HT versus IPC for the management of deep dentinal caries in primary molars.
Children aged 4-9 years old presenting with occlusal or proximal carious lesions of primary molars radiographically extending into the inner third or quarter of dentin will be invited to participate in this study. Patients will be randomized into two treatment groups using online block randomization technique (block of 6) and sealed envelope techniques. Time taken for clinical procedure will be recorded by a research assistant prospectively from the time the child sits on the dental chair till the end of procedure. Child pain perception will be recorded during intervention by a blinded research assistant using the Sound Eye Motor scale (SEM). Parental preference and child acceptance for each procedure will be recorded immediately after treatment using parent and child questionnaires. 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 |
|---|---|---|---|
| Hall Crown Technique | Experimental | preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side. |
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| Indirect pulp capping | Experimental | Selective caries removal to firm dentin followed by placing RMGI base material and subsequent preformed metal crown (PMC) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hall Technique | Procedure | preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient pain perception | will be evaluated by an observer (research assistant who will be trained, calibrated, and blinded to the treatment used) and recorded using the Sound, Eyes, and motor scale (SEM);Based on the intensity of the child's discomfort, each parameter is scored into one of four categories (comfort (score 0), mild discomfort (score 1), moderately painful (score 2), and painful (score 3)). The total score can range from 0 to 9, with 9 indicating the highest level of discomfort. | Perioperatively |
| Rate of Radiographic Success | Absence of radiographic pathology in the root and the bone in the inter-radicular area. | 6,12 months |
| Child acceptance of treatment | Self-reported child acceptance using questionnaire | immediately following intervention |
| Parent acceptance of treatment | Parental acceptance using questionnaire | immediately following intervention |
| 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. | 3,6,12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time taken for intervention | Time taken for providing the intervention, measured in minutes | Perioperative/Periprocedural: from the moment the child sits in the chair until the intervention is completed. |
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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 |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Indirect pulp capping | Procedure | Selective caries removal to hard dentin followed with G.I base material and subsequent preformed metal crown (PMC). |
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