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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSemmelweis University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • with Biodentine

    Procedure/Surgery

    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 MTA

    Procedure/Surgery

    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.

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: direct pulp capping2 interventions
Group B: partial pulpotomy2 interventions
Group C: complete pulpotomy2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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