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

NCT06844448 | Recruiting

• 1 other identifier: 885
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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)

  4 years

Secondary Outcomes (1)

• To establish a relationship between success rate, age, and other co-factors

  4 years

Study Arms (3)

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

with Biodentine PROCEDURE

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

complete pulpotomy; direct pulp capping; partial pulpotomy

with MTA PROCEDURE

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

complete pulpotomy; direct pulp capping; partial pulpotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Department for Restorative Dentistry and Endodontics, Semmelweis University

Budapest, 1088, Hungary

RECRUITING

Related Publications (3)

• 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.

  PMID: 31515048 BACKGROUND

• 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.

  PMID: 24771228 BACKGROUND

• 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.

  PMID: 30664240 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases; Pulpitis

Interventions

tricalcium silicate; Septodont; Pemetrexed

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• János Vág, DMD, PhD

  Semmewleis University, Department of Restorative Dentistry and Endodontics

  STUDY CHAIR

Central Study Contacts

Melinda Zs Polyák, DMD

CONTACT

+36 1 459 1500; polyak.melinda@semmelweis.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)