Predicting Vital Pulp Treatment Outcomes in Symptomatic Pulpits Using Metabolic Biomarker

NCT07452614 — Not applicable, Recruiting, 60 participants, Abeer Ghalib Abdul-khaliq

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Efficacy of Metabolic Biomarkers in Predicting Twelve-Month Outcomes of Vital Pulp Treatment in Symptomatic Teeth With Carious Pulp Exposure: A Controlled Clinical Trial

Registry	NCT07452614
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	60 (Estimated)
Sponsor	Abeer Ghalib Abdul-khaliq (Other)
Conditions	Pulp Disease, Dental, Pulpitis, Reversible Pulpitis, Irreversible Pulpitis (Toothache)
Interventions	vital pulp treatment (Procedure)
Dates	start 2026-02-20, primary completion 2028-06-01 (estimated), completion 2028-10-01 (estimated), first posted 2026-03-05, last updated 2026-04-01
Locations	1 site in Iraq

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Vital Pulp Treatment (VPT)	Experimental	Procedure: vital pulp treatment	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.

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.

+Outcome measures

Primary outcomes

Pulp survival: is overall clinical success at 12 months [From enrollment to the end of 12 months follow-up]: 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.

+Eligibility

Sex: All, ages: 16 Years to 50 Years, accepts healthy volunteers

Inclusion Criteria:

1. Age range of 16-50 years.
2. Pulp exposure during treatment of deep caries.
3. Absence of periodontitis or systemic disease.
4. Only one or two proximal surfaces lost with remaining walls > 2 mm; and
5. Good compliance and signed informed consent forms.

Exclusion Criteria:

1. Patients who meet any of the following criteria will be excluded:
2. Teeth with unrestorable large defects or the need for RCT for aesthetic reasons;
3. Teeth with a negative response to cold testing
4. Current pregnancy or breastfeeding;
5. Poor compliance or inability to complete the trial.
6. The use of medications, including antibiotics, bisphosphonates, or statins, within 3 weeks before the study.
7. Inadequate blood sample collection after pulpal exposure.

+Locations (1)

Facility	City	Country	Status
College of dentistry\ University of Baghdad	Baghdad	Iraq	Recruiting

+Publications

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. PMID 34352305
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. PMID 37772327
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. PMID 31121241

+Investigators

Anas F Mahdee, professor, Study chair, College of dentistry\ University of Baghdad
Abeer G Abdulkhaliq, Principal investigator, College of dentistry\ University of Baghdad