Pulpitis in Permanent TeethpulpitisNCT06960603
Pulp Inflammatory Markers and Outcome of Pulpotomy
A study testing Full pulpotomy in people with Pulpitis in Permanent Teeth and Dental Caries Extending to Pulp, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
This is a prospective clinical study that aims to investigate the level of inflammatory mediators in the inflamed dental pulp and its potential relationship to the outcome of full pulpotomy in mature permanent teeth with carious pulp exposure. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulpitis in Permanent Teeth, Dental Caries Extending to Pulp
- What is being tested?
- Full pulpotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJordan
- Study dates
- 7 Oct 2024to Dec 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Non -contributory medical history (ASA 1)
- Molar tooth with deep caries extending>= 2/3 of dentine or exposing the pulp on the radiograph
- The tooth should give positive response to cold sensibility testing
- Clinical diagnosis of either reversible or irreversible pulpitis based on the symptoms and results of cold testing.
- The tooth is restorable, probing pocket depth and mobility are within normal limits
Who cannot join
- Non-restorable tooth.
- Signs of pulpal necrosis including sinus tract or swelling.
- No enough bleeding after the pulpotomy procedure.
- Inability to achieve hemostasis within 10 min after the pulpotomy.
Trial locations and contacts
1 site in 1 country.
Jordan1 site
Jordan university of science and Technology
Irbid, Irbid Governorate, 22110
About this study
Official title: Effect of Pulp Inflammatory Mediators' Level on the Outcome of Full Pulpotomy in Teeth With Symptomatic Pulpitis
This is a prospective clinical study that aims to investigate the level of inflammatory mediators in the inflamed dental pulp and its potential relationship to the outcome of full pulpotomy in mature permanent teeth with carious pulp exposure.
Pulp blood samples from the teeth will be collected during treatment, MMP9 levels will be recorded using Elisa kits. The teeth will be restored and followed up at 1 week, 6 months, 1, and 2 years. The teeth will be assesses both clinically and radiographically. The procedure will be success if the tooth is asymptomatic clinically and with normal periapical findings. The relationship between MMP9 level and success of treatment will be investigated.
Read the detailed description
Dental caries is one of the most common chronic diseases of adults and children. If left untreated, the disease can have a wide range of dental, medical, social, and quality of life consequences, such as pain, infection, early tooth loss, and loss of self-confidence.
Full pulpotomy is a vital pulp therapy procedure that involves the removal of the coronal pulp to the levels of canal orifices followed by achieving hemostasis and placement of a biocompatible capping material. Full pulpotomy has been proved to be a promising alternative treatment option to the conventional root canal treatment in cariously exposed molars with either diagnosis of reversible or irreversible pulpitis.
Clinically, diagnosing the actual histopathological status of the inflamed pulp is challenging and is an empirical guess based on the results of sensibility testing and patients' symptoms. In recent years there has been an attempt to investigate the level of inflammatory mediators in the pulp, with an attempt to develop a chairside diagnosis tool that will help better in diagnosing the state of the pulp; and therefore, predict the outcome of treatment procedures.
In recent years matrix metalloproteinases (MMPs) have been increasingly studied for their role in the diagnosis of dental inflammatory processes. Several studies evaluated the correlation between inflammation of the dental pulp and the levels of MMPs (MMP-1, -2, -3,-8 and -9), in addition to other molecular markers like interluekins and prostaglandins.
However, the use of concentrations of MMPs in the pulpal blood as a marker to differentiate between reversible and irreversible pulpitis has not been thoroughly investigated yet.
The aim of the study is to investigate the inflammatory mediators' level in inflamed pulps and to assess its relation to the outcome of full pulpotomy in carious teeth with symptomatic pulpitis.
- Being tested
- Full pulpotomy
- Keywords
- Permanent teeth, Deep caries, Reversible pulpitis, Irrevrsible pulpitis, Pulpotomy, Inflammatory mediators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full pulpotomyOther
Also called Cervical pulpotomy
First: Cutting the coronal pulp tissue to the level of the root canal orifices. Second: Followed by taking samples of the pulpal blood Third: Placement of calcium silicate material capping over the pulp
| Study group | Role | What they receive |
|---|---|---|
| Full pulpotomy using calcium silicate based material for teeth with carious pulp exposure | Experimental | The tooth with carious pulp exposure will be treated with full pulpotomy, Blood samples will be collected from the tooth for investigation of inflammatory mediator level. Calcium silicate based material will be placed over the pulp and the tooth will restored with resin composite.
Patients symptoms will be monitored at 1 week postoperatively, the patient will score their pain levels on a scale from 0-10.
The patients will be recalled at 6 and 12 months post procedure. The tooth will be examined for symptoms of pain, and radiographs will be taken. based on the findings it will be scored as success or failure of the pro cedure.
this result will be corelated with the level of measure inflammatory mediators that were taken during the procedure. Receives: Other: Full pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Pain levels after the procedure will be assessed on a scale from 0-10, at 1 week, 6 months an 12 months postoperatively.
The procedure will be considered success if the tooth is symptom free and pain levels range form 0-3.
It will be considered as a failure If pain levels are >0-3
Measured: 1 week, 6 months , 12 months
Secondary outcomes (1)
Radiographic Findings
A periapical x-ray will be taken for the tooth immediately after treatment and at 6 12, and 24 months follow up.
For success the tooth should be free of root resorption and free of bone resorption around the root
Measured: 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start7 Oct 2024
- Primary completion31 Dec 2025
- Study completionDec 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 Pulpitis in Permanent TeethStudies 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
- Permanent teeth with deep caries reaching the dental pulp and requires full pulpotomy treatment
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nessrin Taha, Jordan University of Science and Technology
- Investigators
- Nessrin A Taha, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960603
- Sponsor's protocol ID
- 462/2024
- Other IDs
- 462/2024
- Acronym
- pulpitis
- Status last verified
- Aug 2026
- First submitted
- 26 Apr 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be available upon reasonable request after officila publication and termination of recruitment
Publications
Sharma R, Kumar V, Logani A, Chawla A, Mir RA, Sharma S, Kalaivani M. Association between concentration of active MMP-9 in pulpal blood and pulpotomy outcome in permanent mature teeth with irreversible pulpitis - a preliminary study. Int Endod J. 2021 Apr;54(4):479-489. doi: 10.1111/iej.13437. Epub 2020 Dec 13.
PubMed 33128238Taha NA, About I, Sedgley CM et al. Conservative management of mature permanent teeth with carious pulp exposure. J Endod 2020; 46: S33-S4. Taha NA, Al-Khatib H. 4-Year Follow-up of Full Pulpotomy in Symptomatic Mature Permanent Teeth with Carious Pulp Exposure Using a Stainproof Calcium Silicate-based Material. J Endod 2022; 48: 87-95. Taha NA, Al-Rawash MH, IMRAN ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J 2022; 55:416-29.
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulp Inflammatory Mediators' Level on the Outcome of Full Pulpotomy in Teeth With Symptomatic Pulpitis
- ClinicalTrials.gov ID
- NCT06960603
- Acronym / sponsor ID
- pulpitis / 462/2024
- Keywords
- Permanent teeth, Deep caries, Reversible pulpitis, Irrevrsible pulpitis, Pulpotomy, Inflammatory mediators
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 May 2025 (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 is a prospective clinical study that aims to investigate the level of inflammatory mediators in the inflamed dental pulp and its potential relationship to the outcome of full pulpotomy in mature permanent teeth with carious pulp exposure.
Pulp blood samples from the teeth will be collected during treatment, MMP9 levels will be recorded using Elisa kits. The teeth will be restored and followed up at 1 week, 6 months, 1, and 2 years. The teeth will be assesses both clinically and radiographically. The procedure will be success if the tooth is asymptomatic clinically and with normal periapical findings. The relationship between MMP9 level and success of treatment will be investigated.
Detailed description
Dental caries is one of the most common chronic diseases of adults and children. If left untreated, the disease can have a wide range of dental, medical, social, and quality of life consequences, such as pain, infection, early tooth loss, and loss of self-confidence.
Full pulpotomy is a vital pulp therapy procedure that involves the removal of the coronal pulp to the levels of canal orifices followed by achieving hemostasis and placement of a biocompatible capping material. Full pulpotomy has been proved to be a promising alternative treatment option to the conventional root canal treatment in cariously exposed molars with either diagnosis of reversible or irreversible pulpitis.
Clinically, diagnosing the actual histopathological status of the inflamed pulp is challenging and is an empirical guess based on the results of sensibility testing and patients' symptoms. In recent years there has been an attempt to investigate the level of inflammatory mediators in the pulp, with an attempt to develop a chairside diagnosis tool that will help better in diagnosing the state of the pulp; and therefore, predict the outcome of treatment procedures.
In recent years matrix metalloproteinases (MMPs) have been increasingly studied for their role in the diagnosis of dental inflammatory processes. Several studies evaluated the correlation between inflammation of the dental pulp and the levels of MMPs (MMP-1, -2, -3,-8 and -9), in addition to other molecular markers like interluekins and prostaglandins.
However, the use of concentrations of MMPs in the pulpal blood as a marker to differentiate between reversible and irreversible pulpitis has not been thoroughly investigated yet.
The aim of the study is to investigate the inflammatory mediators' level in inflamed pulps and to assess its relation to the outcome of full pulpotomy in carious teeth with symptomatic pulpitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Permanent teeth with deep caries reaching the dental pulp and requires full pulpotomy treatment
| Arm | Type | Receives |
|---|---|---|
| Full pulpotomy using calcium silicate based material for teeth with carious pulp exposure | Experimental | Other: Full pulpotomyThe tooth with carious pulp exposure will be treated with full pulpotomy, Blood samples will be collected from the tooth for investigation of inflammatory mediator level. Calcium silicate based material will be placed over the pulp and the tooth will restored with resin composite. Patients symptoms will be monitored at 1 week postoperatively, the patient will score their pain levels on a scale from 0-10. The patients will be recalled at 6 and 12 months post procedure. The tooth will be examined for symptoms of pain, and radiographs will be taken. based on the findings it will be scored as success or failure of the pro cedure. this result will be corelated with the level of measure inflammatory mediators that were taken during the procedure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Non -contributory medical history (ASA 1)
Key exclusion criteria (4 listed)
- Non-restorable tooth.
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 |
|---|---|---|
| Full pulpotomyAlso: Cervical pulpotomyFirst: Cutting the coronal pulp tissue to the level of the root canal orifices. Second: Followed by taking samples of the pulpal blood Third: Placement of calcium silicate material capping over the pulp | Other | Full pulpotomy using calcium silicate based material for teeth with carious pulp exposure |
Primary outcome
Pain relief
Time frame: 1 week, 6 months , 12 months
Pain levels after the procedure will be assessed on a scale from 0-10, at 1 week, 6 months an 12 months postoperatively. The procedure will be considered success if the tooth is symptom free and pain levels range form 0-3. It will be considered as a failure If pain levels are >0-3
1 secondary outcome
Radiographic Findings
Time frame: 6, 12, 24 months
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 11 Aug 2026.
- Background: PubMed 33128238Sharma R, Kumar V, Logani A, Chawla A, Mir RA, Sharma S, Kalaivani M. Association between concentration of active MMP-9 in pulpal blood and pulpotomy outcome in permanent mature teeth with irreversible pulpitis - a preliminary study. Int Endod J. 2021 Apr;54(4):479-489. doi: 10.1111/iej.13437. Epub 2020 Dec 13.
- BackgroundTaha NA, About I, Sedgley CM et al. Conservative management of mature permanent teeth with carious pulp exposure. J Endod 2020; 46: S33-S4. Taha NA, Al-Khatib H. 4-Year Follow-up of Full Pulpotomy in Symptomatic Mature Permanent Teeth with Carious Pulp Exposure Using a Stainproof Calcium Silicate-based Material. J Endod 2022; 48: 87-95. Taha NA, Al-Rawash MH, IMRAN ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J 2022; 55:416-29.
- 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.
- Individual participant dataSharing planned: Undecided. The data will be available upon reasonable request after officila publication and termination of recruitment
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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. This study is not recruiting at the moment.
Nessrin A Taha principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full pulpotomy in people with Pulpitis in Permanent Teeth and Dental Caries Extending to Pulp, run by King Abdullah University Hospital at 1 site in Jordan.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 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 Jordan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 1 week, 6 months , 12 months). 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 NCT06960603, 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 11 Aug 2026.