Actively Recruiting

Phase Not Applicable
Age: 16Years - 50Years
All Genders
Healthy Volunteers
ID07452614

Efficacy of Metabolic Biomarkers in Predicting 12-Month Outcomes of Vital Pulp Treatment in Symptomatic Teeth with Carious Pulp Exposure

Led by Abeer Ghalib Abdul-khaliq · Updated on 2026-04-01

60

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether metabolic biomarkers found in pulpal blood at the time of carious pulp exposure can predict the success of vital pulp treatment in symptomatic permanent teeth over 12 months. This controlled clinical trial focuses on patients aged 16 to 50 years with deep carious pulp exposure, aiming to improve pulpal diagnosis and guide treatment decisions using measurable biomarkers. Participants will receive vital pulp treatment, including partial or full pulpotomy, after caries removal. During treatment, pulpal blood samples will be collected and analyzed using High-Performance Liquid Chromatography to detect metabolic biomarkers. Afterward, a calcium silicate-based material will be placed and the tooth will be restored. Outcomes will be tracked clinically and with X-rays over a 12-month period. Throughout the study, participants will undergo clinical and radiographic assessments to evaluate pulp survival and overall treatment success at 12 months. Researchers will monitor participants from enrollment through the follow-up period to measure the primary outcome of pulp vitality. The total participation time spans from initial treatment through one year of observation to assess long-term results.

CONDITIONS

Brief Title

Predicting Vital Pulp Treatment Outcomes in Symptomatic Pulpits Using Metabolic Biomarker

Who Can Participate

Age: 16Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 16 and 50 years
  • Presence of pulp exposure during treatment of deep caries
  • No periodontitis or systemic disease
  • Only one or two proximal tooth surfaces lost with remaining walls greater than 2 mm
  • Good compliance and signed informed consent
Not Eligible

You will not qualify if you...

  • Teeth with large, unrestorable defects or needing root canal treatment for aesthetic reasons
  • Teeth that do not respond to cold testing
  • Current pregnancy or breastfeeding
  • Poor compliance or inability to complete the trial
  • Use of antibiotics, bisphosphonates, or statins within 3 weeks before study
  • Inadequate blood sample collection after pulpal exposure

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment visit

Participants receive vital pulp treatment which involves removal of infected tissue, collection of pulpal blood samples for metabolic biomarker analysis, and placement of a biocompatible material followed by a definitive restoration.

1 visit (in-person)

Follow-up

Duration - 12 months

Participants are monitored for clinical and radiographic outcomes to assess pulp survival over a 12-month period after treatment.

Multiple follow-up visits over 12 months

Trial Site Locations

Total: 1 location

1

College of dentistry\ University of Baghdad

Baghdad, Iraq, 964

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Research Team

A

Abeer G Abdulkhaliq, master degree

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Treatment of pulpal and apical disease: The European Society of Endodontology (ESE) S3-level clinical practice guideline.

Henry F Duncan, Lise-Lotte Kirkevang, Ove A Peters...

https://pubmed.ncbi.nlm.nih.gov/37772327

Vital pulp therapy: histopathology and histobacteriology-based guidelines to treat teeth with deep caries and pulp exposure.

Domenico Ricucci, José F Siqueira, Yuanyuan Li...

https://pubmed.ncbi.nlm.nih.gov/31121241