Using pulpal blood biomarkers to predict success of vital pulp therapy in symptomatic teeth
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 trial will test whether measuring metabolic biomarkers in pulpal blood at the time of carious pulp exposure can help predict 12-month success of vital pulp treatment in people aged 16–50 with symptomatic deep caries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | All |
| Sponsor | University of Baghdad Academic / other |
| Locations | 1 site (Baghdad) |
| Trial ID | NCT07452614 on ClinicalTrials.gov |
What this trial studies
This prospective controlled clinical trial collects pulpal blood at the moment of carious pulp exposure from symptomatic permanent teeth undergoing vital pulp therapy (partial or full pulpotomy). Samples are analyzed by high-performance liquid chromatography (HPLC) to identify metabolic biomarkers. Clinical and radiographic outcomes are recorded at 12 months to determine treatment success. The goal is to find objective, measurable markers that can improve pulpal diagnosis and guide clinicians when choosing vital pulp therapy versus other treatments.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16–50 with symptomatic permanent teeth and deep carious pulp exposure that are restorable, without periodontitis or systemic disease, who can consent and comply with follow-up.
Not a fit: Patients unlikely to benefit include those with nonvital teeth (negative cold test), unrestorable or large defects needing RCT for esthetic reasons, pregnant or breastfeeding individuals, those who recently used certain medications, or those unable to provide an adequate pulpal blood sample or complete follow-up.
Why it matters
Potential benefit: If successful, this approach could give dentists an objective test at the time of exposure to better predict which teeth will do well with vital pulp therapy and reduce unnecessary root canal treatments.
How similar studies have performed: Some preliminary biomarker work in pulp biology shows promise, but using pulpal metabolic profiles by HPLC to predict vital pulp therapy outcomes is a relatively novel approach that is not yet validated in large trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Baghdad
- College of dentistry\ University of Baghdad — Baghdad, Iraq (Recruiting)
Study contacts
- Principal investigator: Abeer G Abdulkhaliq — College of dentistry\ University of Baghdad
- Study coordinator: Abeer G Abdulkhaliq, master degree
- Email: abeer.ghalib@codental.uobaghdad.edu.iq
- Phone: 964+7755564526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.