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The aim of this clinical trial is to learn how successful Biodentine and Theracal PT dental filling materials are in treating deep tooth decay in adults. It will also provide information about post-treatment pain. The main questions it aims to answer are:
Do Biodentine and Theracal PT dental filling materials treat exposed tooth decay in participants? Do they reduce the need for root canal treatment? After the application of Biodentine and Theracal PT dental filling materials to the participants, the pain and symptoms that cause pain may not decrease. In this case, the tooth may be treated with root canal treatment. The researchers will compare the clinical success of Biodentine and Theracal PT dental filling materials with each other.
Participants will undergo a single-session partial pulpotomy treatment with the dental filling materials mentioned above. Clinical and radiographic follow-ups will then be performed at 3, 6 and 12 months, and records will be kept.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial Pulpotomy with Biodentine | Active Comparator |
| |
| Partial Pulpotomy with Theracal PT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France) | Device | It will be placed on the exposed pulp with the help of a carrier and the exposed pulp will be covered with material |
| Measure | Description | Time Frame |
|---|---|---|
| "Tooth survival". Both clinical and radiographic healing means "Tooth survival". Clinical healing; absence of clinical symptoms. Radiographic healing; absence of emerging periapical radiolucency. | From enrollment to the end of treatment at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| "Post operative pain". It will be evaluated with a 10-unit visual analog scale. 0: no pain, 1-3 mild pain, 4-6 moderate-severe pain, 7-9 very severe pain, 10 worst pain. | From enrollment to the follow up at 1 week, 3,6.12 months" |
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Inclusion Criteria:
• Patient age should be between 18-50 years
Exclusion Criteria:
Teeth with incomplete root development
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Firat University | Elâzığ | 23119 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35080024 | Result | Duncan HF. Present status and future directions-Vital pulp treatment and pulp preservation strategies. Int Endod J. 2022 May;55 Suppl 3(Suppl 3):497-511. doi: 10.1111/iej.13688. Epub 2022 Feb 3. | |
| 31121241 | Result | Ricucci D, Siqueira JF Jr, Li Y, Tay FR. Vital pulp therapy: histopathology and histobacteriology-based guidelines to treat teeth with deep caries and pulp exposure. J Dent. 2019 Jul;86:41-52. doi: 10.1016/j.jdent.2019.05.022. Epub 2019 May 21. |
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Title: Data Sharing for Parial Pulpotomy Treatment in Teeth with Cariously Exposed:
The objective of this IPD (Individual Participant Data) sharing plan is to enhance the understanding of the success of partial pulpotomy treatment in cariously exposed teeth using Biodentine and Theracal PT materials, by encouraging and supporting data analysis.
Data Access Conditions: Access to the data is available to researchers who present a valid proposal for research purposes and sign a data use agreement. All applications will be reviewed by the study management committee.
Data Use: Data may only be used for scientific and ethical research purposes. Data Storage: Data will be stored for a period of ten years following the completion of the study and will be securely disposed of at the end of this period.
Data Protection: Data will be stored under strict security protocols and accessible only to authorized personnel.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 5, 2023 | Jan 20, 2025 |
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statistician
| Theracal PT (resin modified calcium silicate-based cement) (Bisco Inc., Schaumburg, IL, USA) | Device | It will be placed on the exposed pulp with the help of its injection tip and the exposed pulp will be covered with material |
|
| 30664240 | Result | European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080. |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 5, 2023 | Jan 25, 2025 | ICF_001.pdf |