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RecruitingNCT06844448Updated Mar 6, 2025

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

An observational study in Dental Caries Extending to Pulp, Pulp Disease, Dental and Irreversible Pulpitis, sponsored by Semmelweis University. Recruiting at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-06.

Primary conditionPulpitisRegistry: Dental Pulp DiseasesReclassifiedWhy we changed it
Registry
Dental Pulp Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pulpitis
Why
  1. The study's listed conditions name Pulpitis, a narrower term within Dental Pulp Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Semmelweis University · Observational

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Dental Caries Extending to Pulp
  • Pulp Disease, Dental
  • Irreversible Pulpitis
  • Reversible Pulpitis
  • Pulpitis

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03

In context

Pulpitis Reclassified

316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.

This study's planned enrollment of 400 is above the median of 75 across 23 observational studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.

Compared within Pulpitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dental Pulp Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Target follow-up
4 Years
Patient registry
Yes

Groups and cohorts

  • direct pulp capping

    After 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.

    Procedure: with Biodentine · Procedure: with MTA

  • partial pulpotomy

    After 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.

    Procedure: with Biodentine · Procedure: with MTA

  • complete pulpotomy

    After 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.

    Procedure: with Biodentine · Procedure: with MTA

Interventions

  • Procedurewith Biodentine

    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.

    Also known as: Biodentine, Septodont

  • Procedurewith MTA

    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.

    Also known as: MTA +, Cercamed

06

What researchers measure

Primary outcomes

  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)

    Time frame: 4 years

Secondary outcomes

  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

    Time frame: 4 years

07

Study locations

1 of 1 sites recruiting
  • Department for Restorative Dentistry and Endodontics, Semmelweis University
    Budapest, 1088, Hungary
    Recruiting
    • János Vág, DMD, PhD · Contactvag.janos@semmelweis.hu · +36209577245
    • Melinda Zs Polyák, DMD · Principal investigator
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2024 (actual). Primary completion is estimated for Jun 2030, 72 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 19, 2025
First posted
Feb 25, 2025
StartActual
Jun 1, 2024
Primary completionEst.
Jun 1, 2030
CompletionEst.
Jun 1, 2030
Last update
Mar 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06844448
Responsible party
Dr. Vag Janos (Professor, Semmelweis University) — Principal investigator
First posted
Feb 25, 2025
Start date
Jun 1, 2024
Primary completion
Jun 1, 2030 (estimated)
Completion
Jun 1, 2030 (estimated)
Last update
Mar 6, 2025

Study contacts

Melinda Zs Polyák, DMD
Contact
polyak.melinda@semmelweis.hu
+36 1 459 1500 ext. 59371
János Vág, DMD, PhD
study chair · Semmewleis University, Department of Restorative Dentistry and Endodontics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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