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This prospective controlled clinical trial investigates whether metabolic biomarkers measured in pulpal blood at the time of carious pulp exposure can predict the 12-month outcomes of vital pulp treatment in symptomatic permanent teeth. Eligible patients aged 16-50 years presenting with deep carious pulp exposure will undergo vital pulp therapy (partial pulpotomy or full pulpotomy). Pulpal blood samples will be collected at the time of exposure and analyzed using High-Performance Liquid Chromatography (HPLC). Treatment outcomes will be assessed clinically and radiographically at 12 months. The study aims to identify objective, measurable biomarkers that can improve pulpal diagnosis and guide clinical decision-making in vital pulp therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vital Pulp Treatment (VPT) | Experimental | Participants with symptomatic teeth and carious pulp exposure will receive vital pulp treatment after caries removal. The specific procedure will be determined intraoperatively based on clinical criteria. Pulpal blood samples will be collected for metabolic biomarker analysis, followed by placement of a calcium silicate- based material and definitive restoration. Clinical and radiographic outcomes will be assessed over 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vital pulp treatment | Procedure | Vital pulp treatment (VPT) is defined by the European Society of Endodontology as a group of biologically based procedures aimed at preserving the health and function of the dental pulp that has been exposed or is at risk of exposure. These procedures involve removal of infected or inflamed tissue where necessary, protection of the remaining vital pulp with a biocompatible material, and placement of a definitive restoration to achieve a hermetic seal and support healing. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulp survival: is overall clinical success at 12 months | Pulp survival: is overall clinical success at 12 months, defined according to COS-ENDO domains as the absence of patient-reported pain, absence of clinical signs of infection, maintenance of normal periradicular status radiographically, preservation of functional tooth structure, and no need for further intervention. | From enrollment to the end of 12 months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abeer G Abdulkhaliq, master degree | Contact | 964+7755564526 | abeer.ghalib@codental.uobaghdad.edu.iq |
| Name | Affiliation | Role |
|---|---|---|
| Anas F Mahdee, professor | College of dentistry\ University of Baghdad | Study Chair |
| Abeer G Abdulkhaliq | College of dentistry\ University of Baghdad | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of dentistry\ University of Baghdad | Recruiting | Baghdad | 964 | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34352305 | Background | AAE Position Statement on Vital Pulp Therapy. J Endod. 2021 Sep;47(9):1340-1344. doi: 10.1016/j.joen.2021.07.015. Epub 2021 Aug 3. No abstract available. | |
| 37772327 | Background | Duncan HF, Kirkevang LL, Peters OA, El-Karim I, Krastl G, Del Fabbro M, Chong BS, Galler KM, Segura-Egea JJ, Kebschull M; ESE Workshop Participants and Methodological Consultant. Treatment of pulpal and apical disease: The European Society of Endodontology (ESE) S3-level clinical practice guideline. Int Endod J. 2023 Oct;56 Suppl 3:238-295. doi: 10.1111/iej.13974. Epub 2023 Sep 29. |
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Individual participant data will not be shared due to ethical and privacy considerations. The study involves collection of biological samples (pulpal blood) and clinical data from patients at the University of Baghdad College of Dentistry. Participant confidentiality is protected under the terms of the signed informed consent forms, which do not include provisions for third-party data sharing. Additionally, as this is a PhD research protocol conducted within an institutional academic setting, data governance policies of the University of Baghdad restrict the external sharing of raw participant-level data. Summary-level findings will be disseminated through peer-reviewed publication.
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| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D011671 | Pulpitis |
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
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This study uses a prospective, controlled, non-randomized interventional clinical trial model conducted at a single academic center. Participants with symptomatic teeth presenting with carious pulp exposure. Allocation to the specific intervention (partial pulpotomy or full pulpotomy) is determined intraoperatively by a calibrated operator based on predefined biological and clinical criteria, including extent of pulp exposure, bleeding characteristics, and tissue appearance.
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The lab personnel who will perform the biomarker measurement test (HPLC)
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| 31121241 | Background | 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |