Irreversible Pulpitis (Toothache), Pulp Disease, Dental, Pulpitis, Reversible Pulpitis
Conditions
Keywords
Vital pulp treatment, Metabolic biomarker, Pulpitis, Carious pulp exposure
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.
Interventions
PROCEDUREvital 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.
Sponsors
Abeer Ghalib Abdul-khaliq
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The lab personnel who will perform the biomarker measurement test (HPLC)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulp survival: is overall clinical success at 12 months | 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. |
Countries
Iraq
Contacts
CONTACTAbeer G Abdulkhaliq, master degree
STUDY_CHAIRAnas F Mahdee, professor
College of dentistry\ University of Baghdad
PRINCIPAL_INVESTIGATORAbeer G Abdulkhaliq
College of dentistry\ University of Baghdad
Outcome results
None listed