Deep CariesPulp capNCT06495242
Direct Pulp Capping Compared to Partial Pulpotomy in Carious Pulp Exposures
A study testing Direct pulp capping and partial pulpotomy in people with Deep Caries, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
This a prospective randomized clinical trial that compare vital pulp therapy procedures in permanent teeth with carious pulp exposure. Patients are recruited from the dental teaching clinics at JUST following preset inclusion criteria. They are subsequently randomly assigned to one of treatment procedures. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries
- What is being tested?
- Direct pulp capping and partial pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteJordan
- Study dates
- 25 Mar 2023to 2 Dec 2027
- 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 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Non -contributory medical history (ASA 1)
- Molar tooth with extremely deep caries extending>2/3 of dentin or exposing the pulp on the periapical radiograph
- The tooth should give positive response to cold testing
- Clinical diagnosis of reversible pulpitis with mild to moderate symptoms
- The tooth is restorable, probing pocket depth and mobility are within normal limits
- No signs of pulpal necrosis including sinus tract or swelling
- No radiographic evidence of periapical changes indicative of apical periodontitis
Who cannot join
- Immature teeth
- Nonvital teeth
- Irreversible pulpitis and periapical periodontitis, i.e spontaneous and lingering pain.
- Inability to achieve hemostasis after 6 minutes of application of 5% NaOCl moist pellet
- No pulp exposure after nonselective caries removal
Trial locations and contacts
1 site in 1 country.
Jordan1 site
Faculty of Dentistry, Jordan University of Science and Technology
Irbid, Irbid Governorate, 3030
About this study
Official title: Outcome of Direct Pulp Capping Compared to Partial Pulpotomy in the Management of Carious Pulp Exposures in Mature Teeth: A Randomized Clinical Trial
This a prospective randomized clinical trial that compare vital pulp therapy procedures in permanent teeth with carious pulp exposure. Patients are recruited from the dental teaching clinics at JUST following preset inclusion criteria. They are subsequently randomly assigned to one of treatment procedures. Clinical and radiographic follow up is performed after 6 months and yearly up to 5 years.
Read the detailed description
Background: Deep carious lesions are commonly encountered in both adults and children with no clear consensus on the ideal clinical management. Vital pulp therapy including direct pulp capping and pulpotomy is increasingly considered in the management of carious pulp exposures when the clinical diagnosis is reversible pulpitis with variable reports of success rates with different materials used and different diagnostic categories.
Aims: The aims of this study are to evaluate the clinical and radiographic outcomes of direct pulp capping and partial pulpotomy in deep carious lesions of mature permanent teeth using a calcium silicate based material (Biodentine, Septodont, France), and to investigate the relationship between matrix metalloproteinase (MMP 9) levels in the pulpal blood and the outcome of these procedures.
Methods: 120 mature molar teeth in 120 patients with deep carious lesions exposing the pulps on the radiograph and with symptoms of reversible pulpitis will be included in the study. The teeth will be subsequently randomly divided into 2 groups (n=60). One group will receive direct pulp capping and composite restoration, and the second group will receive partial pulpotomy and composite restoration. Pulpal blood will be collected from the exposure site and will be tested for the level of MMP9 using special ElISA kit. Preoperative and postoperative pain level at 48 hours and 7 days will be evaluated on a scale from 0-10.
The treated teeth will be further evaluated clinically and radiographically at 6 and 12 months follow up and yearly afterward. The relationship of the outcome to the level of MMP9 will be investigated. The results will be statistically analyzed using appropriate tests in the SPSS software.
Expected results: Since partial pulpotomy includes the removal of 2-3 mm of the exposed pulp tissue which is theoretically inflamed, it is expected to be more effective in alleviating the patient's symptoms and to have a higher success rate than simply pulp capping the carious exposure. High levels of MMP9 are also expected to have a correlation with the failure rate.
- Conditions
- Deep Caries
- Being tested
- Direct pulp capping and partial pulpotomy
- Keywords
- Caries, pulpitis, direct pulp capping, partial pulpotomy,, pain
- Medical subject headings
- Pulpitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct pulp capping and partial pulpotomyProcedure or surgery
Also called Partial pulpotomy
Two types of vital pulp therapy procedures
| Study group | Role | What they receive |
|---|---|---|
| Direct pulp capping | Active comparator | After caries excavation and pulp exposure, the cavity is disinfected . the capping material is applied and the tooth is restored. Receives: Procedure: Direct pulp capping and partial pulpotomy |
| Partial pulpotomy | Active comparator | After caries excavation and pulp exposure, 2-3 mm of the exposed pulp are cut . The capping material is applied and the tooth is restored. Receives: Procedure: Direct pulp capping and partial pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term clinical outcome
Resolution of clinical symptoms
Measured: one week
Secondary outcomes (1)
long term outcome
Maintenance of pulp vitality
Measured: 1-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start25 Mar 2023
- Primary completion28 Dec 2024
- Study completion2 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Deep CariesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomized clinical trial including 2 treatment groups with 1;1 allocation ration
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Principal investigator, Nessrin Taha, King Abdullah University Hospital
- Investigators
- Prof Nessrin A Taha, PhD, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495242
- Sponsor's protocol ID
- 131/2023
- Acronym
- Pulp cap
- Status last verified
- Aug 2026
- First submitted
- 2 Jul 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Original data can be provided upon a reasonable request, and may be available after publication
Publications
Taha NA, Albakri SW. Outcome and Prognostic Factors for Partial and Full Pulpotomy in the Management of Spontaneous Symptomatic Pulpitis in Carious Mature Permanent Teeth: A Randomized Clinical Trial. J Endod. 2024 Jul;50(7):889-898. doi: 10.1016/j.joen.2024.03.012. Epub 2024 Apr 5.
PubMed 38583758Taha NA, Khazali MA. Partial Pulpotomy in Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2017 Sep;43(9):1417-1421. doi: 10.1016/j.joen.2017.03.033. Epub 2017 Jun 30.
PubMed 28673494Taha 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 Jan;48(1):87-95. doi: 10.1016/j.joen.2021.09.008. Epub 2021 Sep 24.
PubMed 34563506Taha 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 May;55(5):416-429. doi: 10.1111/iej.13707. Epub 2022 Mar 17.
PubMed 35152464Taha NA, Ahmad MB, Ghanim A. Assessment of Mineral Trioxide Aggregate pulpotomy in mature permanent teeth with carious exposures. Int Endod J. 2017 Feb;50(2):117-125. doi: 10.1111/iej.12605. Epub 2016 Jan 30.
PubMed 26715408
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
- Outcome of Direct Pulp Capping Compared to Partial Pulpotomy in the Management of Carious Pulp Exposures in Mature Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06495242
- Acronym / sponsor ID
- Pulp cap / 131/2023
- Conditions
- Deep Caries
- Keywords
- Caries, pulpitis, direct pulp capping, partial pulpotomy,, pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 25 Mar 2023 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 2 Dec 2027 (estimated)
- First posted
- 10 Jul 2024 (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 a prospective randomized clinical trial that compare vital pulp therapy procedures in permanent teeth with carious pulp exposure. Patients are recruited from the dental teaching clinics at JUST following preset inclusion criteria. They are subsequently randomly assigned to one of treatment procedures. Clinical and radiographic follow up is performed after 6 months and yearly up to 5 years.
Detailed description
Background: Deep carious lesions are commonly encountered in both adults and children with no clear consensus on the ideal clinical management. Vital pulp therapy including direct pulp capping and pulpotomy is increasingly considered in the management of carious pulp exposures when the clinical diagnosis is reversible pulpitis with variable reports of success rates with different materials used and different diagnostic categories.
Aims: The aims of this study are to evaluate the clinical and radiographic outcomes of direct pulp capping and partial pulpotomy in deep carious lesions of mature permanent teeth using a calcium silicate based material (Biodentine, Septodont, France), and to investigate the relationship between matrix metalloproteinase (MMP 9) levels in the pulpal blood and the outcome of these procedures.
Methods: 120 mature molar teeth in 120 patients with deep carious lesions exposing the pulps on the radiograph and with symptoms of reversible pulpitis will be included in the study. The teeth will be subsequently randomly divided into 2 groups (n=60). One group will receive direct pulp capping and composite restoration, and the second group will receive partial pulpotomy and composite restoration. Pulpal blood will be collected from the exposure site and will be tested for the level of MMP9 using special ElISA kit. Preoperative and postoperative pain level at 48 hours and 7 days will be evaluated on a scale from 0-10.
The treated teeth will be further evaluated clinically and radiographically at 6 and 12 months follow up and yearly afterward. The relationship of the outcome to the level of MMP9 will be investigated. The results will be statistically analyzed using appropriate tests in the SPSS software.
Expected results: Since partial pulpotomy includes the removal of 2-3 mm of the exposed pulp tissue which is theoretically inflamed, it is expected to be more effective in alleviating the patient's symptoms and to have a higher success rate than simply pulp capping the carious exposure. High levels of MMP9 are also expected to have a correlation with the failure rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel randomized clinical trial including 2 treatment groups with 1;1 allocation ration
| Arm | Type | Receives |
|---|---|---|
| Direct pulp capping | Active comparator | Procedure: Direct pulp capping and partial pulpotomyAfter caries excavation and pulp exposure, the cavity is disinfected . the capping material is applied and the tooth is restored. |
| Partial pulpotomy | Active comparator | Procedure: Direct pulp capping and partial pulpotomyAfter caries excavation and pulp exposure, 2-3 mm of the exposed pulp are cut . The capping material is applied and the tooth is restored. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Non -contributory medical history (ASA 1)
- Molar tooth with extremely deep caries extending>2/3 of dentin or exposing the pulp on the periapical radiograph
- The tooth should give positive response to cold testing
- Clinical diagnosis of reversible pulpitis with mild to moderate symptoms
- The tooth is restorable, probing pocket depth and mobility are within normal limits
Key exclusion criteria (5 listed)
- Immature teeth
- Nonvital teeth
- Irreversible pulpitis and periapical periodontitis, i.e spontaneous and lingering pain.
- Inability to achieve hemostasis after 6 minutes of application of 5% NaOCl moist pellet
- No pulp exposure after nonselective caries removal
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 |
|---|---|---|
| Direct pulp capping and partial pulpotomyAlso: Partial pulpotomyTwo types of vital pulp therapy procedures | Procedure or surgery | Direct pulp capping, Partial pulpotomy |
Primary outcome
Short term clinical outcome
Time frame: one week
Resolution of clinical symptoms
1 secondary outcome
long term outcome
Time frame: 1-5 years
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 38583758Taha NA, Albakri SW. Outcome and Prognostic Factors for Partial and Full Pulpotomy in the Management of Spontaneous Symptomatic Pulpitis in Carious Mature Permanent Teeth: A Randomized Clinical Trial. J Endod. 2024 Jul;50(7):889-898. doi: 10.1016/j.joen.2024.03.012. Epub 2024 Apr 5.
- Background: PubMed 28673494Taha NA, Khazali MA. Partial Pulpotomy in Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2017 Sep;43(9):1417-1421. doi: 10.1016/j.joen.2017.03.033. Epub 2017 Jun 30.
- Background: PubMed 34563506Taha 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 Jan;48(1):87-95. doi: 10.1016/j.joen.2021.09.008. Epub 2021 Sep 24.
- Background: PubMed 35152464Taha 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 May;55(5):416-429. doi: 10.1111/iej.13707. Epub 2022 Mar 17.
- Background: PubMed 26715408Taha NA, Ahmad MB, Ghanim A. Assessment of Mineral Trioxide Aggregate pulpotomy in mature permanent teeth with carious exposures. Int Endod J. 2017 Feb;50(2):117-125. doi: 10.1111/iej.12605. Epub 2016 Jan 30.
- Individual participant dataSharing planned: Undecided. Original data can be provided upon a reasonable request, and may be available after 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. This study is not recruiting at the moment.
Prof Nessrin A Taha, PhD 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 Direct pulp capping and partial pulpotomy in people with Deep Caries, 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 7 inclusion and 5 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?
Short term clinical outcome (time frame: one week). 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 NCT06495242, which also lists 5 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.