Predicting Vital Pulp Treatment Outcomes in Symptomatic Pulpits Using Metabolic Biomarker

NCT07452614 | Recruiting

• 1 other identifier: 1176526
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulp Disease, Dental; Pulpitis; Reversible Pulpitis; Irreversible Pulpitis (Toothache)

Keywords

Vital pulp treatment; Metabolic biomarker; Pulpitis; Carious pulp exposure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Procedure: vital pulp treatment

Interventions

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.

Vital Pulp Treatment (VPT)

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Abeer Ghalib Abdul-khaliq: lead

Study Sites (1)

College of dentistry\ University of Baghdad

Baghdad, 964, Iraq

RECRUITING

Related Publications (3)

• 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 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.

  PMID: 37772327 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.

  PMID: 31121241 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases; Pulpitis; Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anas F Mahdee, professor

  College of dentistry\ University of Baghdad

  STUDY CHAIR

• Abeer G Abdulkhaliq

  College of dentistry\ University of Baghdad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abeer G Abdulkhaliq, master degree

CONTACT

964+7755564526; abeer.ghalib@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The lab personnel who will perform the biomarker measurement test (HPLC)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 5, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)