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RecruitingNCT07452614Updated Apr 1, 2026

Predicting Vital Pulp Treatment Outcomes in Symptomatic Pulpits Using Metabolic Biomarker

An interventional study of vital pulp treatment in Pulp Disease, Dental, Pulpitis and Reversible Pulpitis, sponsored by Abeer Ghalib Abdul-khaliq. Recruiting at 1 site in Iraq. Open to participants aged 16 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-01.

Primary conditionPulpitisRegistry: Dental Pulp DiseasesReclassifiedWhy we changed it
Registry
Dental Pulp Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pulpitis
Why
  1. The study's listed conditions name Pulpitis, a narrower term within Dental Pulp Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Abeer Ghalib Abdul-khaliq · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
16 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

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

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Keywords

  • Vital pulp treatment
  • Metabolic biomarker
  • Pulpitis
  • Carious pulp exposure
03

In context

Pulpitis Reclassified

316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.

This study's planned enrollment of 60 is close to the median of 64 across 288 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

This is the only study on the registry with Abeer Ghalib Abdul-khaliq as lead sponsor.

Compared within Pulpitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dental Pulp Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
16 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 forms.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Vital Pulp Treatment (VPT)

    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

  • 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.

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What researchers measure

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.

    Time frame: From enrollment to the end of 12 months follow-up

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 34352305 ↗
  • 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. PubMed 37772327 ↗
  • 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. PubMed 31121241 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared due to ethical and privacy considerations. The study involves collection of biological samples (pulpal blood) and clinical data from patients at the University of Baghdad College of Dentistry. Participant confidentiality is protected under the terms of the signed informed consent forms, which do not include provisions for third-party data sharing. Additionally, as this is a PhD research protocol conducted within an institutional academic setting, data governance policies of the University of Baghdad restrict the external sharing of raw participant-level data. Summary-level findings will be disseminated through peer-reviewed publication.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07452614
Lead sponsor
Abeer Ghalib Abdul-khaliq
Responsible party
Abeer Ghalib Abdul-khaliq (Dr., University of Baghdad) — Sponsor-investigator
First posted
Mar 5, 2026
Start date
Feb 20, 2026
Primary completion
Jun 2028 (estimated)
Completion
Oct 2028 (estimated)
Last update
Apr 1, 2026

Study contacts

Abeer G Abdulkhaliq, master degree
Contact
abeer.ghalib@codental.uobaghdad.edu.iq
964+7755564526
Anas F Mahdee, professor
study chair · College of dentistry\ University of Baghdad
Abeer G Abdulkhaliq
principal investigator · College of dentistry\ University of Baghdad

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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