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This clinical trial will be conducted to clinical, radiographical and histological evaluation of pulp condition with reversible pulpities after total and selective removal of primary and secondary caries (randomized clinical trial and exo-vivo study)
Randomized clinical trial Sample size 144 case…
Randomization method used:
Sample size calculation was performed using R statistical analysis software version 4.3.2 for Windows
Outcome variables:
Pulp vitality and post operative pain Grouping classified into four groups as follows: The first group : total caries removal of primary caries(PTCR) 27 The second group: selective caries removal of primary caries(PSCR) The third group: total caries removal of secondary caries(STCR) The fourth group : selecive caries removal of secondary caries(SSCR)
Expected Time table:
2 years Recall of patient after 3,6,9 and 12 months 6 months for writing and 6 months for data analyzed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total caries removal in primary caries | Active Comparator | Total caries removal Removal of all caries and application of bioactive material |
|
| Total caries removal of secondary caries | Active Comparator | Total caries removal of caries of recurrent caries |
|
| Partial caries removal of primary caries | Active Comparator | Partial caries removal and application of bioactive material |
|
| Partial caries removal of secondary caries | Active Comparator | Partical caries removal of recurrent caries |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total caries removal | Procedure | Total caries removal and application of bioactive material |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical evaluation ………. Radiographic evaluation: | clinical evaluation: absence of pain , pulp vitality, ………. Radiographic evaluation: absence of any periapical lesion or recurrent caries | 1year |
| Measure | Description | Time Frame |
|---|---|---|
| histological evaluation and follow up | histological evaluation after one year. T (Time): follow up evaluation periods of pulp condition immediately post operative (base line ), after 3, 6, 9 and 12 month and exo-vivo study. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Systemic medical conditions, pregnancy, alcoholic and smoker patients. 2- Teeth with spontaneous pain or percussion sensitivity in periodontal lesions, external or internal root resorption, sinus opening, mobility, or abscessed tooth. 3- Radiographic evidence of widened periodontal space, broken or interrupted lamina dura, and periapical radiolucency. 4- Intensified erosion damage or periodontitis. Patient reported clenching or bruxism, hopeless or non-restorable teeth. Immature teeth. 5- Patients with physical disabilities preventing tooth brushing. Patient had removable partial denture abutments, dental abscesses, pulp lesions, atypical facial pain, or pulpitis. 6- Patients had non-carious lesions like abrasion, erosion, attrition, or abfraction.
7- Patients with history of antibiotic or analgesics intake within few days of operative intervention. 8- Patients with previously root canal-treated teeth. 9- Periodontally compromised teeth. 10-Teeth that will be extracted for periodontal or orthodontic reasons as it will conduct for histological evaluation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abeer M. Shehata, MASTER | Contact | 00201094238606 | abeer.shehata@mu.edu.eg | |
| Abeer M. Shehata, master | Contact | 00201094830487 | abeermasr@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Abeer Mohmaed Shehata, Master | Minia University | Principal Investigator |
| Rasha Saad, lecturer | Minia University | Study Director |
| Mohammed Torky, Associate professor |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39442480 | Background | Taha NA, Ali MM, Abidin IZ, Khader YS. Pulp survival and postoperative treatment needs following selective vs. total caries removal in mature permanent teeth with reversible pulpitis: A randomized clinical trial. J Dent. 2024 Dec;151:105408. doi: 10.1016/j.jdent.2024.105408. Epub 2024 Oct 22. | |
| 36110733 | Background |
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|
| Partial caries removal | Procedure | Partial caries removal then application of biodentin |
|
|
| Minia University |
| Study Director |
| Nermin Mahmoud, Associate professor | Minia University | Study Director |
| Ahlawat M, Grewal MS, Goel M, Bhullar HK, Saurabh, Nagpal R. Direct Pulp Capping with Mineral Trioxide Aggregate and Biodentine in Cariously Exposed Molar Teeth: 1-Year Follow-up - An In vivo Study. J Pharm Bioallied Sci. 2022 Jul;14(Suppl 1):S983-S985. doi: 10.4103/jpbs.jpbs_837_21. Epub 2022 Jul 13. |
| 37250608 | Background | Drouri S, El Merini H, Sy A, Jabri M. Evaluation of Direct and Indirect Pulp Capping With Biodentine in Vital Permanent Teeth With Deep Caries Lesions. Cureus. 2023 May 23;15(5):e39374. doi: 10.7759/cureus.39374. eCollection 2023 May. |