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NCT Number: NCT07452614

Predicting Vital Pulp Treatment Outcomes in Symptomatic Pulpits Using Metabolic Biomarker

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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Key information

Conditions

Pulp Disease, Dental Dental Pulp Diseases Facial Pain Irreversible Pulpitis (Toothache) Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pulpitis Reversible Pulpitis Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of dentistry\ University of Baghdad

Baghdad, 964, Iraq

Location status: Recruiting

Location contact

Abeer G Abdulkhaliq, master

CONTACT

[email protected]

964+7755564526

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abeer G Abdulkhaliq, master degree

CONTACT

[email protected]

964+7755564526

Sponsors and collaborators

Lead sponsor

Abeer Ghalib Abdul-khaliq

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 5, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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