Actively Recruiting

Age: 18Years +
All Genders
ID06844448

The Effect of Different Risk Factors on the Success Rate of Vital Pulp Therapy An Observational Prospective Cohort Study

Led by Semmelweis University · Updated on 2025-03-06

400

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the effectiveness of different vital pulp therapy (VPT) methods—direct pulp capping, partial pulpotomy, and complete pulpotomy—in preserving the vitality of dental pulp after pulp exposure. This observational prospective cohort study also explores how factors such as age influence treatment success, aiming to identify if there is an age threshold that affects the choice of VPT over root canal therapy. The study involves adult patients with restorable teeth and exposed pulp chambers, tracking outcomes over a period of up to four years. The study treatments begin with local anesthesia and isolation of the tooth, followed by disinfection and removal of caries under a microscope. Depending on the severity and extent of pulp inflammation, participants receive one of three VPT methods: direct pulp capping, partial pulpotomy removing a small portion of pulp tissue, or complete pulpotomy removing all coronal pulp tissue. Materials such as Biodentine or MTA are applied to the pulp, followed by temporary and then permanent restorations. Treatments are delivered carefully with bleeding control steps and follow-up procedures at specified intervals. Participants will be monitored through clinical and radiological examinations at 7 days, 6 months, and annually up to 4 years after treatment. Data including patient complaints, clinical findings, and radiographs are recorded to assess success using standardized indexes. The study tracks healing and pulp vitality, measuring treatment success by combining patient symptoms with clinical and X-ray results. This thorough follow-up allows researchers to compare the success rates of different VPT methods and understand the influence of age and other factors on outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years of age who have at least one tooth with a pulp chamber opened or likely to be opened during dental restoration
  • The affected tooth responds to a sensitivity test with cold spray
  • The coronal part of the tooth is restorable
  • The probing depth around the tooth is 3.5 mm or less, indicating healthy gum support
Not Eligible

You will not qualify if you...

  • Presence of internal or external resorption in the tooth
  • Tooth root development is incomplete or the tooth is a deciduous (baby) tooth
  • Unable to achieve absolute isolation during the dental procedure
  • No pulp exposure occurs even after complete caries removal
  • The crown of the tooth cannot be restored
  • Moderate to severe marginal periodontitis affecting the tooth (probing depth greater than 3.5 mm)
  • Pulp exposure caused by traumatic injury
  • Baseline radiograph shows severe pulp calcification
  • Presence of periapical lesion around the root with an index greater than 2

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 week

Participants receive one of three types of vital pulp therapy procedures (direct pulp capping, partial pulpotomy, or complete pulpotomy) according to clinical indications. After local anaesthesia and tooth isolation, the pulp is treated with either Biodentine or MTA. One week later, participants return for removal of temporary restoration and placement of permanent restoration.

2 visits (in-person): initial treatment and 1-week restoration visit

Follow-up

Duration - 4 years

Participants are monitored through clinical examinations and radiographs to assess treatment success and any changes in symptoms or tooth condition.

Visits at 7 days, 6 months, 1 year, 2 years, 3 years, and 4 years after treatment

Trial Site Locations

Total: 1 location

1

Department for Restorative Dentistry and Endodontics, Semmelweis University

Budapest, Hungary, 1088

Actively Recruiting

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Research Team

M

Melinda Zs Polyák, DMD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Outcome of Partial Pulpotomy in Cariously Exposed Posterior Permanent Teeth: A Systematic Review and Meta-analysis.

Firas Elmsmari, Xavier-Fructuós Ruiz, Queralt Miró...

https://pubmed.ncbi.nlm.nih.gov/31515048

Five-year results of vital pulp therapy in permanent molars with irreversible pulpitis: a non-inferiority multicenter randomized clinical trial.

Saeed Asgary, Mohammad Jafar Eghbal, Mahta Fazlyab...

https://pubmed.ncbi.nlm.nih.gov/24771228

European Society of Endodontology position statement: Management of deep caries and the exposed pulp.

European Society of Endodontology (ESE) developed by:, H F Duncan, K M Galler...

https://pubmed.ncbi.nlm.nih.gov/30664240