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Dental Caries Extending to PulpNCT06844448

The Effect of Different Risk Factors on the Success Rate of VPT

An observational study of Dental Caries Extending to Pulp and Pulp Disease, Dental, run by Semmelweis University at 1 site in Hungary.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the effectiveness of various vital pulp therapy (VPT) methods, such as direct pulp capping, partial pulpotomy, and total pulpotomy, in maintaining pulp vitality following pulp exposure. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
with Biodentine and with MTA
Type of treatment
Surgery or procedure
How many people
400 participants
Where
1 siteHungary
Study dates
1 Jun 2024to 1 Jun 2030
How long will I take part?
4 Years
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
  • Adult, Older adult

Study population: Patients for the study will be selected from adult patients presenting at the ambulance of the Semmelweis University Department of Restorative Dentistry and Endodontics and who meet the inclusion criteria

Who may be able to join

  • Patients over 18 years of age who have at least one tooth with a pulp chamber that has been opened during a dental procedure or is likely to be opened during restoration of the tooth
  • The tooth is responsive to a sensitivity test with cold spray
  • The coronal part must be restorable
  • The periodontal depth around the tooth should be 0 according to the Dental Practicality Index Periodontal Treatment Need, i.e. the probing depth around the tooth should not be greater than 3.5 mm

Who cannot join

  • Internal/external resorption in the tooth
  • If the root development of the tooth is not yet complete or if it is a deciduous tooth
  • Absolute isolation cannot be performed during the procedure
  • If pulp exposure does not occur even after complete removal of caries
  • The crown of the tooth cannot be restored
  • Periodontium surrounding tooth affected by moderate/severe marginal periodontitis (probing depth deeper than 3.5 mm)
Show all 9Show fewer
  • Pulp exposure due to traumatic injury
  • Baseline radiograph shows signs of severe pulp palcification
  • Periapical lesion is around the root (Periapical index of the tooth >2)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hungary1 site, 1 recruiting
  • Department for Restorative Dentistry and Endodontics, Semmelweis University

    Budapest, 1088

    János Vág, DMD, PhD, +36209577245, vag.janos@semmelweis.hu

    Melinda Zs Polyák, DMD

    Recruiting

Other trials in Hungary

About this study

Official title: The Effect of Different Risk Factors on the Success Rate of VPT: an Observational Prospective Cohort Study

This study aims to evaluate the effectiveness of various vital pulp therapy (VPT) methods, such as direct pulp capping, partial pulpotomy, and total pulpotomy, in maintaining pulp vitality following pulp exposure. It explores the success rates of these treatments compared and investigates co-factors influencing these rates, including age. This prospective cohort study involves patients over 18 with restorable teeth and exposed pulp chambers. Success is measured through clinical and radiological criteria over a follow-up period of up to four years. The study also aims to identify if there's an age threshold affecting the preference for VPT over root canal therapy.

Read the detailed description

Objectives: The primary objective of this study is to explore the effectiveness of different VPT methods after pulp exposure. A secondary objective is to establish the relationship between success rate, age and other co-factors.

Study methodology: We plan a single-centre, three-arm, observational prospective cohort study. The study will be organised and hosted by the Department of Restorative Dentistry and Endodontics, Semmelweis University. Patients for the study will be selected from patients presenting at the ambulance of the Semmelweis University Department of Restorative Dentistry and Endodontics.

For patients who meet the inclusion criteria, we record the patient's baseline clinical data Baseline data, as well as information obtained during the study and findings during follow-up (7 days, 6 months, 1 year, 2 years, 3 years, 4 years) are recorded by the interventionalist in an online database (REDCap).

Interventions are carried out according to the following steps: After local anaesthesia (Lidocaine-adrenaline 20 mg/0.01 mg/ml, Egis, Budapest, Hungary) and mouth rinsing with 0.2% chlorhexidine, the tooth is absolutely isolated using a rubber dam and liquid dam (Opaldam- Ultradent, South-Jordan, Utah). The coronal part of the tooth is then disinfected with a cotton pellet soaked in 5% sodium hypochlorite (NaOCl). Under an operating microscope, the caries is removed non-selectively, first with a diamond bur under water cooling, then with a steel bur inserted in a handpiece, moving from the periphery of the tooth towards the pulpal wall. The absence of caries on non-pulpal walls is confirmed by caries indicator (Sable Seek-Ultradent, South-Jordan, Utah). The pulp chamber is opened with a sterile diamond bur in a turbine with copious water cooling. After opening the pulp, different types of treatment are used depending on the extent of inflammation and caries.

  1. Direct pulp capping: Pressure of a sterile cotton pellet soaked in 2.5% NaOCl is applied to the exposed pulp to achieve hemostasis. After the bleeding has stopped, the cavity is flushed with sterile saline and Biodentine (Septodont, Saint-Maur-des-Fossés, France) or MTA is mixed according to the manufacturer's instructions. The patient is called back after 1 week, when the temporary restoration is removed and a final restoration is placed in the cavity, which may be a composite filling, inlay or crown, depending on the amount of remaining tooth material. This type of intervention is performed (1) if a healthy tooth with a normal pulp has suffered iatrogenic pulp exposure and the pulp tissue is surrounded by intact dentin tissue, and (2) when it is asymptomatic, or with reversible pulpitis symptoms after extra deep caries removal, there is no dentin chips are the pulp tissue, it is surrounded by healthy dentin, there is no evidence of necrosis in the pulp, and bleeding can be controlled within 5 minutes with a cotton pellet soaked in 2.5% NaOCl. Direct pulp capping will berejected if the patient has spontaneous pain before treatment, bleeding from the pulp is not controllable within 5 minutes, necrotic tissue is present in the pulp chamber, or if the pulp is explose through carious dentin.
  2. Partial pulpotomy After opening of the pulp with a sterile diamond bur, an additional 2-3 mm of coronal pulp tissue is removed with copious water cooling. Subsequently, light pressure is applied to the pulp for 5 minutes with a cotton pellet dipped in 2.5% NaOCl to control bleeding. After controlling the bleeding, the cavity is flushed with sterile saline and Biodentine or MTA is applied the same way as in case of direct pulp capping. Partial pulpotomy is the treatment of choice in the following clinical situations: (1) in case of extra-deep caries the bacterial biofilm and infected dentin can be only removed by superficial pulp excision, (2) when further caries removal is required after pulp exposure due to the risk of infected dentin shavings entering the pulp, (3) in the case of normal pulp after extra-deep caries removal, bleeding cannot be controlled within 5 minutes after direct pulp capping attempt, (4) in the case of reversible pulpitis, if bleeding cannot be stopped within 5 minutes after pulp exposure. We exclude from partial pulpotomy treatment, for any of the above indications, cases where bleeding cannot be stopped within 5 minutes.
  3. Complete pulpotomy During a total coronal pulpotomy, the coronal pulp tissue is removed down to the level of the orifices using a sterile diamond bur with copious water cooling. Bleeding is controlled by gentle pressure with a cotton pellet soaked in 2.5% NaOCl. When the bleeding stops, the cavity is flushed with sterile saline and Biodentine or MTA is applied the same way as in case of direct pulp capping. Complete pulpotomy is the treatment type of choice in the following clinical situations: (1) reversible pulpitis/normal pulp with anemic necrotic tissue in the pulp, (2) reversible pulpitis, normal pulp after partial pulpotomy if bleeding cannot be controlled in 5 minutes, (3) if the patient's complaints include spontaneous or persistent pain/night pain. Exclusion criteria for complete pulpotomy treatment include (1) bleeding uncontrollable in 5 minutes, or (2) anaemic/necrotic tissue at the level of the orifices.

The patients will be consulted about any complaints or changes in complaints 7 days after the procedure, at the same time as the final restoration is made. If there are no previous complaints, the patient will be referred back for a follow-up examination six months after the procedure. Then, after recording any complaints, a control radiograph and clinical examination (inspection, palpation, palpation, periodontal pocket probing) are performed. The same is repeated 1 year, 2 years, 3 years and 4 years after treatment. Evaluation of the results: The success of the treatment is evaluated by combining the patient's subjective complaints with the results of the clinical examination and periapical radiograph. The periapical index (PAI) is used to assess the periapical space on radiographs.

Being tested
with Biodentine, with MTA
Medical subject headings
Dental Pulp Diseases, Pulpitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • with BiodentineProcedure or surgery

    Also called Biodentine, Septodont

    After the bleeding has stopped, the cavity is flushed with sterile saline and Biodentine (Septodont, Saint-Maur-des-Fossés, France) is mixed according to the manufacturer's instructions. First it is applied directly to the pulp wound using light pressure, and then the entire cavity is filled with it. One week later the superficial 2-3 mm is removed and replaced it with permanent restoration.

  • with MTAProcedure or surgery

    Also called MTA +, Cercamed

    After the bleeding has stopped, the cavity is flushed with sterile saline and MTA+ (Cercamed, Stalowa Wola, Poland) is mixed according to the manufacturer's instructions. First it is applied directly to the pulp wound using light pressure, and after its initial setting the cavity is filled with glass ionomer cement. One week later the glass ionomer cement is removed and replaced it with permanent restoration.

Study groups in NCT06844448
Study groupRoleWhat they receive
direct pulp cappingAfter local anaesthesia the tooth is absolutely isolated. The coronal part of the tooth is then disinfected with a cotton pellet soaked in 5% sodium hypochlorite. Under an operating microscope, the caries is removed non-selectively towards the pulpal wall. The absence of caries on non-pulpal walls is confirmed by caries indicator. The pulp chamber is opened with a sterile diamond bur in a turbine with copious water cooling. After opening the pulp gentle pressure of a sterile cotton pellet soaked in 2.5% NaOCl is applied to the exposed pulp to achieve hemostasis.
Receives: Procedure: with Biodentine; Procedure: with MTA
partial pulpotomyAfter local anaesthesia the tooth is absolutely isolated. The coronal part of the tooth is then disinfected with a cotton pellet soaked in 5% sodium hypochlorite. Under an operating microscope, the caries is removed non-selectively towards the pulpal wall. The absence of caries on non-pulpal walls is confirmed by caries indicator. The pulp chamber is opened with a sterile diamond bur in a turbine with copious water cooling. After opening of the pulp with a sterile diamond bur, an additional 2-3 mm of coronal pulp tissue is removed with copious water cooling. Subsequently, light pressure is applied to the pulp for 5 minutes with a cotton pellet dipped in 2.5% NaOCl to control bleeding.
Receives: Procedure: with Biodentine; Procedure: with MTA
complete pulpotomyAfter local anaesthesia the tooth is absolutely isolated. The coronal part of the tooth is then disinfected with a cotton pellet soaked in 5% sodium hypochlorite. Under an operating microscope, the caries is removed non-selectively towards the pulpal wall. The absence of caries on non-pulpal walls is confirmed by caries indicator. After the coronal pulp tissue is removed down to the level of the orifices using a sterile diamond bur with copious water cooling. Bleeding is controlled by gentle pressure with a cotton pellet soaked in 2.5% NaOCl.
Receives: Procedure: with Biodentine; Procedure: with MTA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare the success rate between direct pulp capping, partial pulpotomy, and full pulpotomy

    To measure the percentage of patients without any sympoms (0 on VAS scale), pain on percussion, palpation and without any radiographic sign of periapical pathosis (PAI 1 or 2)

    Measured: 4 years

Secondary outcomes (1)
  1. To establish a relationship between success rate, age, and other co-factors

    The ratio of successful participants in older population, in population with systemic diseases

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2025
  2. Study start1 Jun 2024
  3. Primary completion1 Jun 2030 (estimated)
  4. Study completion1 Jun 2030 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
Target duration
4 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06844448
Sponsor's protocol ID
885
Status last verified
Mar 2025
First submitted
19 Feb 2025
Last updated
6 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Elmsmari F, Ruiz XF, Miro Q, Feijoo-Pato N, Duran-Sindreu F, Olivieri JG. Outcome of Partial Pulpotomy in Cariously Exposed Posterior Permanent Teeth: A Systematic Review and Meta-analysis. J Endod. 2019 Nov;45(11):1296-1306.e3. doi: 10.1016/j.joen.2019.07.005. Epub 2019 Sep 10.

    PubMed 31515048
  • Asgary S, Eghbal MJ, Fazlyab M, Baghban AA, Ghoddusi J. Five-year results of vital pulp therapy in permanent molars with irreversible pulpitis: a non-inferiority multicenter randomized clinical trial. Clin Oral Investig. 2015 Mar;19(2):335-41. doi: 10.1007/s00784-014-1244-z. Epub 2014 Apr 27.

    PubMed 24771228
  • European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.

    PubMed 30664240

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Caries Extending to Pulp and Pulp Disease, Dental, run by Semmelweis University at 1 site in Hungary.

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 4 inclusion and 9 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 6 Mar 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 Hungary. 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 Melinda Zs Polyák, DMD (+36 1 459 1500 ext. 59371, polyak.melinda@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare the success rate between direct pulp capping, partial pulpotomy, and full pulpotomy (time frame: 4 years). 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 NCT06844448, 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 6 Mar 2025.

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