Irreversible PulpitisNCT06918639
Effectiveness of Pulpotomy in Symptomatic Permanent Teeth With Deep Caries Lesions
An observational study of Irreversible Pulpitis and Pulpotomy of Permanent Molars, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Preservation of pulp tissue would allow it to continue to exert its defensive and physiological functions and more tooth tissue would be preserved, leading to less weakening of the tooth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irreversible Pulpitis, Pulpotomy of Permanent Molars
- What is being tested?
- Pulpotomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 11 Apr 2024to 1 Jan 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients (a minimum of 50 teeth, based on previous studies evaluating the success of pulpotomies requiring partial pulpotomy or complete pulpotomy treatment in permanent teeth with closed apex, with symptomatology of pulpitis, both reversible and irreversible, who meet the remaining inclusion criteria, will be recruited.
Who may be able to join
- Patients over 18 years of age.
- Patients in good general health, ASA I or ASA II with no contraindications to contraindications to receive a TPV procedure under local anaesthesia.
- Tooth with symptomatology of pulpitis, both reversible and irreversible, to be determined by history of spontaneous pain, exacerbation of pain with heat and cold confirmed by the cold test and radiating pain.
- Tooth without signs of pulp necrosis and absence of sinus tract and abscess.
- Tooth in occlusion with antagonist tooth and without discomfort on chewing.
- Tooth that can be directly restored.
- Tooth with pocket depth and mobility within normal limits.
- Extent of the caries lesion greater than two thirds of the amelodentine distance or which tooth or the pulp has been exposed during caries removal.
Who cannot join
- Patients with allergies or intolerance to any anaesthetic solution.
- Pregnant patients or patients who suspect pregnancy due to the impossibility of complementary radiographic tests cannot be carried out.
- Patients with systemic pathology that prevents the use of a vasoconstrictor or with a compromised immune system that may influence the response to treatment.
- Tooth with an immature apex.
- Tooth that is not restorable or not viable for preservation.
- Tooth with negative response to thermal sensitivity test or electrical test.
- Tooth in which haemostasis cannot be achieved after exposure of the pulp, or with a pulp, or with a haemostasis time exceeding 10 minutes, where there is no pulp bleeding or partial or complete tissue necrosis is observed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Rey Juan Carlos University
Alcorcón, Madrid, 28922
Laura Ceballos, Full Professor, +34 667056606, laura.ceballos@urjc.es
Olga González-Castro, DDS
About this study
Preservation of pulp tissue would allow it to continue to exert its defensive and physiological functions and more tooth tissue would be preserved, leading to less weakening of the tooth. In addition, root canal treatment is a more complex therapeutic process that requires the use of more instruments, more time and more visits. To date, most clinical studies that have evaluated the success of pulpotomy treatments have been conducted on teeth with immature apexes. More studies are needed to evaluate VPT success in the permanent dentition in the long term.
In accordance with the above, the main objective of the study will be to determine the success of partial or total pulpotomy treatment in permanent teeth (\>18 adults) with a closed apex and symptoms compatible with irreversible pulpitis. At the same time, the association of factors related to the patient, the treated tooth and specific treatment factors with the success of pulpotomies will be determined. On the other hand, the patient, perception and satisfaction with the treatment received will be evaluated.
Read more
All treatments (pulpotomies and restorations) will be carried out by the principal investigator.
After recording the preoperative data, clinical and radiographic examination, a diagnosis will be made according to the classification of Wolters and collaborators , which will also guide us in the choice of pulp treatment: PP o CP Partial pulpotomy or complete pulpotomy. The maximum pulp haemostasis time will be 10 minutes. In both treatments, in the same appointment, the definitive restoration of the tooth will be carried out.
The evaluations will be performed at one week, 3 , 6 and 12 months postoperatively. This evaluation shall be performed by an examiner who shall be different from the one performing the treatment.
The main outcome of the present study will be the determination of the success of the pulpotomies.
- Is vital pulp therapy a highly successful treatment for teeth with irreversible pulpitis?.
Outcome measure 1: Success rate of vital pulp therapy
- Do patients feel satisfied with this conservative pulp treatment? Outcome measure 2: Patient´s satisfaction with vital pulp therapy
Read the detailed description
Success shall be determined by the absence of signs and symptoms in addition to maintenance of pulp vitality. The presence of symptoms compatible with the presence of pulp pathology or the observation of pathological radiolucent lesions will indicate the need for root canal treatment and will be considered failure of vital pulp therapy treatment.
After completion of the procedure, a patient survey will be given to the patient to record the patients, perception and satisfaction with the treatment received.
- Being tested
- Pulpotomy
- Keywords
- pulpotomy, vitalpulptherapy, partialpulpotomy, biodentinexp, fullpulpotomy, completepulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
VPT: Partial pulpotomy: 2 mm of pulp tissue is removed with a high speed 014 diamond round bur different from the one used to remove carious tissue. In those cases in which access to the pulp tissue induces a painful sensation due to failure of the anaesthetic technique, intrapulpal anaesthesia shall be used, and this parameter shall be recorded.Cotton wool impregnated with 2.5% stabilised sodium hypochlorite shall be held over the pulp exposure to achieve haemostasis. If it is not possible to control bleeding, proceed to a complete pulpotomy procedure. If in this case it is impossible to achieve haemostasis, the possibility of performing a TPV is ruled out and the RCT is excluded from the study. Once haemostasis has been achieved, BiodentineXp is applied according to the manufacturer's instructions and a material thickness of 2-3 mm is ensured. Full pulpotomy: The same anterior procedure .Complete removal of the tissue from the pulp chamber. Maximum haemostasis time: 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| to determinate the success of partial and total pulpotomy in permanent teeth | The main outcome of the present study will be the success rate of the treatment, determined by the absence of symptoms of irreversible pulpitis and the absence of radiological images compatible with pathology. The type of pulpotomy (partial or total) to be performed on each tooth will not be randomised for ethical reasons but, unlike other studies, will be determined clinically at the time of treatment according to the indication. Subsequently, the success of each treatment will be compared. Receives: Procedure: Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of the vital pulpt treatment
The evaluation will be according to clinical and radiographic parameters:
- Clinical: absence of spontaneous pain, normal probing depth, no movility, no sinus tract or swelling.
- Radiographic findings: No periapical lesions.
Measured: From the treatment to the one-year follow-up.
Secondary outcomes (1)
Patient satisfaction with vital pulp treatment
A specific questionnaire has been designed in which patients are asked about the characteristics of the pain before the treatment and 24 hours, 3 and 7 days afterwards, using a visual rating scale. The values ranged between 0 and 10, being 0 the absence of pain and 10 the maximum pain. Moreover, they were also asked regarding the treatment impact on esthetics, function and comfort. Also, a numerical rating scale was used, ranging from 1 to 10, being 10 the maximum satisfaction.
Measured: From enrollement to the first control visit, 7 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start11 Apr 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Irreversible PulpitisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OLGA GONZÁLEZ CASTRO, Universidad Rey Juan Carlos
- Investigators
- Laura Ceballos, Full Professor, DDS, PhD, Study director, Universidad Rey Juan CarlosVictoria Fuentes, Associate Professor, DDS, PhD, Study director, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918639
- Sponsor's protocol ID
- 100120240392024
- Status last verified
- Apr 2025
- First submitted
- 27 Jun 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Careddu R, Plotino G, Cotti E, Duncan HF. The management of deep carious lesions and the exposed pulp amongst members of two European endodontic societies: a questionnaire-based study. Int Endod J. 2021 Mar;54(3):366-376. doi: 10.1111/iej.13418. Epub 2020 Oct 19.
PubMed 32970860Wolters WJ, Duncan HF, Tomson PL, Karim IE, McKenna G, Dorri M, Stangvaltaite L, van der Sluis LWM. Minimally invasive endodontics: a new diagnostic system for assessing pulpitis and subsequent treatment needs. Int Endod J. 2017 Sep;50(9):825-829. doi: 10.1111/iej.12793. No abstract available.
PubMed 28776717Ramani A, Sangwan P, Tewari S, Duhan J, Mittal S, Kumar V. Comparative evaluation of complete and partial pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2022 May;55(5):430-440. doi: 10.1111/iej.13714. Epub 2022 Mar 10.
PubMed 35226769Jassal A, Nawal RR, Yadav S, Talwar S, Yadav S, Duncan HF. Outcome of partial and full pulpotomy in cariously exposed mature molars with symptoms indicative of irreversible pulpitis: A randomized controlled trial. Int Endod J. 2023 Mar;56(3):331-344. doi: 10.1111/iej.13872. Epub 2022 Dec 4.
PubMed 36403208Esteve-Pardo G, Barreiro-Gabeiras P, Esteve-Colomina L. Pulpectomy vs. Pulpotomy as Alternative Emergency Treatments for Symptomatic Irreversible Pulpitis-A Multicenter Comparative Randomised Clinical Trial on Patient Perceptions. Clin Pract. 2023 Aug 2;13(4):898-913. doi: 10.3390/clinpract13040082.
PubMed 37623263Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12.
PubMed 36504246Taha NA, Abdelkhader SZ. Outcome of full pulpotomy using Biodentine in adult patients with symptoms indicative of irreversible pulpitis. Int Endod J. 2018 Aug;51(8):819-828. doi: 10.1111/iej.12903. Epub 2018 Feb 27.
PubMed 29397003Taha 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, Abuzaid AM, Khader YS. A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction. J Endod. 2023 Jun;49(6):624-631.e2. doi: 10.1016/j.joen.2023.04.001. Epub 2023 Apr 19.
PubMed 37080387Ricucci 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 31121241Smith AJ, Duncan HF, Diogenes A, Simon S, Cooper PR. Exploiting the Bioactive Properties of the Dentin-Pulp Complex in Regenerative Endodontics. J Endod. 2016 Jan;42(1):47-56. doi: 10.1016/j.joen.2015.10.019.
PubMed 26699924
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pulpotomy in Symptomatic Permanent Teeth With Deep Caries Lesions
- ClinicalTrials.gov ID
- NCT06918639
- Acronym / sponsor ID
- 100120240392024
- Keywords
- pulpotomy, vitalpulptherapy, partialpulpotomy, biodentinexp, fullpulpotomy, completepulpotomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 9 Apr 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.
Preservation of pulp tissue would allow it to continue to exert its defensive and physiological functions and more tooth tissue would be preserved, leading to less weakening of the tooth. In addition, root canal treatment is a more complex therapeutic process that requires the use of more instruments, more time and more visits. To date, most clinical studies that have evaluated the success of pulpotomy treatments have been conducted on teeth with immature apexes. More studies are needed to evaluate VPT success in the permanent dentition in the long term.
In accordance with the above, the main objective of the study will be to determine the success of partial or total pulpotomy treatment in permanent teeth (\>18 adults) with a closed apex and symptoms compatible with irreversible pulpitis. At the same time, the association of factors related to the patient, the treated tooth and specific treatment factors with the success of pulpotomies will be determined. On the other hand, the patient, perception and satisfaction with the treatment received will be evaluated.
All treatments (pulpotomies and restorations) will be carried out by the principal investigator.
After recording the preoperative data, clinical and radiographic examination, a diagnosis will be made according to the classification of Wolters and collaborators , which will also guide us in the choice of pulp treatment: PP o CP Partial pulpotomy or complete pulpotomy. The maximum pulp haemostasis time will be 10 minutes. In both treatments, in the same appointment, the definitive restoration of the tooth will be carried out.
The evaluations will be performed at one week, 3 , 6 and 12 months postoperatively. This evaluation shall be performed by an examiner who shall be different from the one performing the treatment.
The main outcome of the present study will be the determination of the success of the pulpotomies.
- Is vital pulp therapy a highly successful treatment for teeth with irreversible pulpitis?.
Outcome measure 1: Success rate of vital pulp therapy
- Do patients feel satisfied with this conservative pulp treatment? Outcome measure 2: Patient´s satisfaction with vital pulp therapy
Detailed description
Success shall be determined by the absence of signs and symptoms in addition to maintenance of pulp vitality. The presence of symptoms compatible with the presence of pulp pathology or the observation of pathological radiolucent lesions will indicate the need for root canal treatment and will be considered failure of vital pulp therapy treatment.
After completion of the procedure, a patient survey will be given to the patient to record the patients, perception and satisfaction with the treatment received.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| to determinate the success of partial and total pulpotomy in permanent teeth | – | Procedure: PulpotomyThe main outcome of the present study will be the success rate of the treatment, determined by the absence of symptoms of irreversible pulpitis and the absence of radiological images compatible with pathology. The type of pulpotomy (partial or total) to be performed on each tooth will not be randomised for ethical reasons but, unlike other studies, will be determined clinically at the time of treatment according to the indication. Subsequently, the success of each treatment will be compared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients (a minimum of 50 teeth, based on previous studies evaluating the success of pulpotomies requiring partial pulpotomy or complete pulpotomy treatment in permanent teeth with closed apex, with symptomatology of pulpitis, both reversible and irreversible, who meet the remaining inclusion criteria, will be recruited.
Key inclusion criteria (8 listed)
- Patients over 18 years of age.
- Patients in good general health, ASA I or ASA II with no contraindications to contraindications to receive a TPV procedure under local anaesthesia.
- Tooth with symptomatology of pulpitis, both reversible and irreversible, to be determined by history of spontaneous pain, exacerbation of pain with heat and cold confirmed by the cold test and radiating pain.
- Tooth without signs of pulp necrosis and absence of sinus tract and abscess.
- Tooth in occlusion with antagonist tooth and without discomfort on chewing.
Key exclusion criteria (7 listed)
- Patients with allergies or intolerance to any anaesthetic solution.
- Pregnant patients or patients who suspect pregnancy due to the impossibility of complementary radiographic tests cannot be carried out.
- Patients with systemic pathology that prevents the use of a vasoconstrictor or with a compromised immune system that may influence the response to treatment.
- Tooth with an immature apex.
- Tooth that is not restorable or not viable for preservation.
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 |
|---|---|---|
| PulpotomyVPT: Partial pulpotomy: 2 mm of pulp tissue is removed with a high speed 014 diamond round bur different from the one used to remove carious tissue. In those cases in which access to the pulp tissue induces a painful sensation due to failure of the anaesthetic technique, intrapulpal anaesthesia shall be used, and this parameter shall be recorded.Cotton wool impregnated with 2.5% stabilised sodium hypochlorite shall be held over the pulp exposure to achieve haemostasis. If it is not possible to control bleeding, proceed to a complete pulpotomy procedure. If in this case it is impossible to achieve haemostasis, the possibility of performing a TPV is ruled out and the RCT is excluded from the study. Once haemostasis has been achieved, BiodentineXp is applied according to the manufacturer's instructions and a material thickness of 2-3 mm is ensured. Full pulpotomy: The same anterior procedure .Complete removal of the tissue from the pulp chamber. Maximum haemostasis time: 10 minutes | Procedure or surgery | to determinate the success of partial and total pulpotomy in permanent teeth |
Primary outcome
Success rate of the vital pulpt treatment
Time frame: From the treatment to the one-year follow-up.
The evaluation will be according to clinical and radiographic parameters: * Clinical: absence of spontaneous pain, normal probing depth, no movility, no sinus tract or swelling. * Radiographic findings: No periapical lesions.
1 secondary outcome
Patient satisfaction with vital pulp treatment
Time frame: From enrollement to the first control visit, 7 days later
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 9 Apr 2025.
- Background: PubMed 32970860Careddu R, Plotino G, Cotti E, Duncan HF. The management of deep carious lesions and the exposed pulp amongst members of two European endodontic societies: a questionnaire-based study. Int Endod J. 2021 Mar;54(3):366-376. doi: 10.1111/iej.13418. Epub 2020 Oct 19.
- Background: PubMed 28776717Wolters WJ, Duncan HF, Tomson PL, Karim IE, McKenna G, Dorri M, Stangvaltaite L, van der Sluis LWM. Minimally invasive endodontics: a new diagnostic system for assessing pulpitis and subsequent treatment needs. Int Endod J. 2017 Sep;50(9):825-829. doi: 10.1111/iej.12793. No abstract available.
- Background: PubMed 35226769Ramani A, Sangwan P, Tewari S, Duhan J, Mittal S, Kumar V. Comparative evaluation of complete and partial pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2022 May;55(5):430-440. doi: 10.1111/iej.13714. Epub 2022 Mar 10.
- Background: PubMed 36403208Jassal A, Nawal RR, Yadav S, Talwar S, Yadav S, Duncan HF. Outcome of partial and full pulpotomy in cariously exposed mature molars with symptoms indicative of irreversible pulpitis: A randomized controlled trial. Int Endod J. 2023 Mar;56(3):331-344. doi: 10.1111/iej.13872. Epub 2022 Dec 4.
- Background: PubMed 37623263Esteve-Pardo G, Barreiro-Gabeiras P, Esteve-Colomina L. Pulpectomy vs. Pulpotomy as Alternative Emergency Treatments for Symptomatic Irreversible Pulpitis-A Multicenter Comparative Randomised Clinical Trial on Patient Perceptions. Clin Pract. 2023 Aug 2;13(4):898-913. doi: 10.3390/clinpract13040082.
- Background: PubMed 36504246Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12.
- Background: PubMed 29397003Taha NA, Abdelkhader SZ. Outcome of full pulpotomy using Biodentine in adult patients with symptoms indicative of irreversible pulpitis. Int Endod J. 2018 Aug;51(8):819-828. doi: 10.1111/iej.12903. Epub 2018 Feb 27.
- 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 37080387Taha NA, Abuzaid AM, Khader YS. A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction. J Endod. 2023 Jun;49(6):624-631.e2. doi: 10.1016/j.joen.2023.04.001. Epub 2023 Apr 19.
- 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.
- Background: PubMed 26699924Smith AJ, Duncan HF, Diogenes A, Simon S, Cooper PR. Exploiting the Bioactive Properties of the Dentin-Pulp Complex in Regenerative Endodontics. J Endod. 2016 Jan;42(1):47-56. doi: 10.1016/j.joen.2015.10.019.
- Individual participant dataSharing planned: No
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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.
Laura Ceballos, Full Professor, DDS, PhD study director
Universidad Rey Juan Carlos
Victoria Fuentes, Associate Professor, DDS, PhD study director
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irreversible Pulpitis and Pulpotomy of Permanent Molars, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 8 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 9 Apr 2025. 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 Spain. 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 OLGA GONZÁLEZ-CASTRO, DDS (+34667938051, olga.gonzalez.castro@clinica.urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of the vital pulpt treatment (time frame: From the treatment to the one-year 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 NCT06918639, which also lists 11 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 9 Apr 2025.