Pulp Disease, DentalNCT07452614
Predicting Vital Pulp Treatment Outcomes in Symptomatic Pulpits Using Metabolic Biomarker
A study testing vital pulp treatment in people with Pulp Disease, Dental and Pulpitis, run by Abeer Ghalib Abdul-khaliq at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Disease, Dental, Pulpitis, Reversible Pulpitis
- What is being tested?
- vital pulp treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 20 Feb 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
College of dentistry\ University of Baghdad
Baghdad, 964
Abeer G Abdulkhaliq, master, 964+7755564526, abeer.ghalib@codental.uobaghdad.edu.iq
About this study
Official 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
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.
- Being tested
- vital pulp treatment
- Keywords
- Vital pulp treatment, Metabolic biomarker, Pulpitis, Carious pulp exposure
- Medical subject headings
- Dental Pulp Diseases, Pulpitis, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vital pulp treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Vital Pulp Treatment (VPT) | Experimental | 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. Receives: Procedure: vital pulp treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start20 Feb 2026
- Primary completionJun 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulp Disease, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abeer Ghalib Abdul-khaliq
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abeer Ghalib Abdul-khaliq, University of Baghdad
- Investigators
- Anas F Mahdee, professor, Study chair, College of dentistry\ University of BaghdadAbeer G Abdulkhaliq, Principal investigator, College of dentistry\ University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452614
- Sponsor's protocol ID
- 1176526
- Status last verified
- Mar 2026
- First submitted
- 28 Feb 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 34352305Duncan 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 37772327Ricucci 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07452614
- Acronym / sponsor ID
- 1176526
- Keywords
- Vital pulp treatment, Metabolic biomarker, Pulpitis, Carious pulp exposure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Abeer Ghalib Abdul-khaliqUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vital Pulp Treatment (VPT) | Experimental | Procedure: vital pulp treatmentParticipants 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. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vital pulp treatmentVital 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. | Procedure or surgery | Vital Pulp Treatment (VPT) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 34352305AAE 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.
- Background: PubMed 37772327Duncan 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.
- Background: PubMed 31121241Ricucci 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anas F Mahdee, professor study chair
College of dentistry\ University of Baghdad
Abeer G Abdulkhaliq principal investigator
College of dentistry\ University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vital pulp treatment in people with Pulp Disease, Dental and Pulpitis, run by Abeer Ghalib Abdul-khaliq at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abeer G Abdulkhaliq, master degree (964+7755564526, abeer.ghalib@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulp survival: is overall clinical success at 12 months (time frame: From enrollment to the end of 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07452614, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.