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Will Calcium-Enriched Mixture (CEM) cement pulpotomy have less postoperative pain and more clinical and radiographic success compared to Calcium Hydroxide/Iodoform (Metapex) pulpectomy when managing second primary molars with irreversible pulpitis?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulpotomy Group | Experimental | Children in this group will undergo pulpotomy of second primary molars diagnosed with irreversible pulpitis using Calcium-Enriched Mixture (CEM) cement. The procedure includes coronal pulp removal, hemostasis, placement of CEM cement as a base over the pulp tissue, and final restoration with glass ionomer cement followed by stainless steel crown. |
|
| pulpectomy group | Experimental | Children in this group will undergo pulpectomy of second primary molars diagnosed with irreversible pulpitis using Calcium Hydroxide/Iodoform paste (Metapex). The procedure includes complete removal of the pulp tissue, canal instrumentation and irrigation, obturation with Metapex, and final restoration with glass ionomer cement followed by stainless steel crown. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulpotomy using Calcium-Enriched Mixture (CEM) Cement | Procedure | pulpotomy procedure using (CEM) Cement as pulp dressing material |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Intensity | Pain intensity will be evaluated using the Visual Analog Scale (VAS) of faces, rated from 0 (no pain) to 5 (severe pain). Assessment will be performed at 1, 3, 6, 9, and 12 months after treatment. Clinical success will be considered when the patient reports no pain (score = 0). | 1, 3, 6, 9, and 12 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Clinical Success | Clinical success will be evaluated by the absence of pain, swelling, tenderness to percussion, sinus, fistula, and pathological mobility. Clinical assessment will be performed at 1, 3, 6, 9, and 12 months postoperatively. | 1, 3, 6, 9, and 12 months post-treatment |
| Evaluation of Radiographic Success |
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Inclusion Criteria:
Aged 6-8 years of both sexes. Cooperative and medically free. Diagnosed with irreversible pulpitis based on clinical and radiographic criteria.
Parents/legal guardians provide written informed consent. Parents able to attend follow-up visits.
Teeth:
Deep carious second primary molars with signs of irreversible pulpitis. No clinical signs of necrosis (abscess, fistula, mobility). No radiographic signs of necrosis (periapical lesion or resorption).
Exclusion Criteria:
With systemic or mental disorders. Whose parents refuse to give consent. Uncooperative behavior.
Teeth:
Signs of pulpal necrosis (swelling, fistula, pathological mobility). Periapical or furcal radiolucency exceeding half the furcation-apical distance. Non-restorable teeth, root caries, internal/external resorption, or calcified canals.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alaa Hassab Elrasoul Abdelmajed, Master degree | Contact | 00201507339601 | alaa.abdelmagid@dentistry.cu.edu.eg |
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| ID | Term |
|---|---|
| D002721 | omega-Chloroacetophenone |
| D003738 | Dental Cements |
| C498115 | Metapex |
| ID | Term |
|---|---|
| D000098 | Acetophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D003764 | Dental Materials |
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statistician
| Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex) | Procedure | pulpectomy procdure performed using Metapex paste as root canal filling material |
|
Radiographic success will be defined as the absence of widening of the periodontal ligament space, internal/external root resorption, or radiolucency in the furcation or periapical area. Radiographic failure will be recorded if any of these findings are observed. |
| 6 and 12 months post-treatment |
| D001697 |
| Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |