Predicting Vital Pulp Treatment Outcomes in Symptomatic Pulpits Using Metabolic Biomarker

March 26, 2026 updated by: Abeer Ghalib Abdul-khaliq

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vital Pulp Treatment (VPT)
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.
Procedure: vital pulp treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulp survival: is overall clinical success at 12 months
Time Frame: 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.
From enrollment to the end of 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abeer Ghalib Abdul-khaliq

Investigators

  • Study Chair: Anas F Mahdee, professor, College of dentistry\ University of Baghdad
  • Principal Investigator: Abeer G Abdulkhaliq, College of dentistry\ University of Baghdad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

February 28, 2026

First Submitted That Met QC Criteria

February 28, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1176526

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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