Effectiveness of Pulpotomy in Symptomatic Permanent Teeth With Deep Caries Lesions

April 6, 2025 updated by: OLGA GONZÁLEZ CASTRO, Universidad Rey Juan Carlos

Preservation of pulp tissue would allow it to continue to exert its defensive and physiological functions and more tooth tissue would be preserved, leading to less weakening of the tooth. In addition, root canal treatment is a more complex therapeutic process that requires the use of more instruments, more time and more visits. To date, most clinical studies that have evaluated the success of pulpotomy treatments have been conducted on teeth with immature apexes. More studies are needed to evaluate VPT success in the permanent dentition in the long term.

In accordance with the above, the main objective of the study will be to determine the success of partial or total pulpotomy treatment in permanent teeth (>18 adults) with a closed apex and symptoms compatible with irreversible pulpitis. At the same time, the association of factors related to the patient, the treated tooth and specific treatment factors with the success of pulpotomies will be determined. On the other hand, the patient, perception and satisfaction with the treatment received will be evaluated.

All treatments (pulpotomies and restorations) will be carried out by the principal investigator.

After recording the preoperative data, clinical and radiographic examination, a diagnosis will be made according to the classification of Wolters and collaborators , which will also guide us in the choice of pulp treatment: PP o CP Partial pulpotomy or complete pulpotomy. The maximum pulp haemostasis time will be 10 minutes. In both treatments, in the same appointment, the definitive restoration of the tooth will be carried out.

The evaluations will be performed at one week, 3 , 6 and 12 months postoperatively. This evaluation shall be performed by an examiner who shall be different from the one performing the treatment.

The main outcome of the present study will be the determination of the success of the pulpotomies.

- Is vital pulp therapy a highly successful treatment for teeth with irreversible pulpitis?.

Outcome measure 1: Success rate of vital pulp therapy

- Do patients feel satisfied with this conservative pulp treatment? Outcome measure 2: Patient´s satisfaction with vital pulp therapy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Success shall be determined by the absence of signs and symptoms in addition to maintenance of pulp vitality. The presence of symptoms compatible with the presence of pulp pathology or the observation of pathological radiolucent lesions will indicate the need for root canal treatment and will be considered failure of vital pulp therapy treatment.

After completion of the procedure, a patient survey will be given to the patient to record the patients, perception and satisfaction with the treatment received.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Recruiting
        • Rey Juan Carlos University
        • Contact:
        • Contact:
          • Olga González-Castro, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults patients (a minimum of 50 teeth, based on previous studies evaluating the success of pulpotomies requiring partial pulpotomy or complete pulpotomy treatment in permanent teeth with closed apex, with symptomatology of pulpitis, both reversible and irreversible, who meet the remaining inclusion criteria, will be recruited.

Description

Inclusion Criteria:

  • Patients over 18 years of age.
  • Patients in good general health, ASA I or ASA II with no contraindications to contraindications to receive a TPV procedure under local anaesthesia.
  • Tooth with symptomatology of pulpitis, both reversible and irreversible, to be determined by history of spontaneous pain, exacerbation of pain with heat and cold confirmed by the cold test and radiating pain.
  • Tooth without signs of pulp necrosis and absence of sinus tract and abscess.
  • Tooth in occlusion with antagonist tooth and without discomfort on chewing.
  • Tooth that can be directly restored.
  • Tooth with pocket depth and mobility within normal limits.
  • Extent of the caries lesion greater than two thirds of the amelodentine distance or which tooth or the pulp has been exposed during caries removal.

Exclusion Criteria:

  • Patients with allergies or intolerance to any anaesthetic solution.
  • Pregnant patients or patients who suspect pregnancy due to the impossibility of complementary radiographic tests cannot be carried out.
  • Patients with systemic pathology that prevents the use of a vasoconstrictor or with a compromised immune system that may influence the response to treatment.
  • Tooth with an immature apex.
  • Tooth that is not restorable or not viable for preservation.
  • Tooth with negative response to thermal sensitivity test or electrical test.
  • Tooth in which haemostasis cannot be achieved after exposure of the pulp, or with a pulp, or with a haemostasis time exceeding 10 minutes, where there is no pulp bleeding or partial or complete tissue necrosis is observed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
to determinate the success of partial and total pulpotomy in permanent teeth
The main outcome of the present study will be the success rate of the treatment, determined by the absence of symptoms of irreversible pulpitis and the absence of radiological images compatible with pathology. The type of pulpotomy (partial or total) to be performed on each tooth will not be randomised for ethical reasons but, unlike other studies, will be determined clinically at the time of treatment according to the indication. Subsequently, the success of each treatment will be compared.
Procedure: Pulpotomy
VPT: Partial pulpotomy: 2 mm of pulp tissue is removed with a high speed 014 diamond round bur different from the one used to remove carious tissue. In those cases in which access to the pulp tissue induces a painful sensation due to failure of the anaesthetic technique, intrapulpal anaesthesia shall be used, and this parameter shall be recorded.Cotton wool impregnated with 2.5% stabilised sodium hypochlorite shall be held over the pulp exposure to achieve haemostasis. If it is not possible to control bleeding, proceed to a complete pulpotomy procedure. If in this case it is impossible to achieve haemostasis, the possibility of performing a TPV is ruled out and the RCT is excluded from the study. Once haemostasis has been achieved, BiodentineXp is applied according to the manufacturer's instructions and a material thickness of 2-3 mm is ensured. Full pulpotomy: The same anterior procedure .Complete removal of the tissue from the pulp chamber. Maximum haemostasis time: 10 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of the vital pulpt treatment
Time Frame: From the treatment to the one-year follow-up.

The evaluation will be according to clinical and radiographic parameters:

  • Clinical: absence of spontaneous pain, normal probing depth, no movility, no sinus tract or swelling.
  • Radiographic findings: No periapical lesions.
From the treatment to the one-year follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with vital pulp treatment
Time Frame: From enrollement to the first control visit, 7 days later
A specific questionnaire has been designed in which patients are asked about the characteristics of the pain before the treatment and 24 hours, 3 and 7 days afterwards, using a visual rating scale. The values ranged between 0 and 10, being 0 the absence of pain and 10 the maximum pain. Moreover, they were also asked regarding the treatment impact on esthetics, function and comfort. Also, a numerical rating scale was used, ranging from 1 to 10, being 10 the maximum satisfaction.
From enrollement to the first control visit, 7 days later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Rey Juan Carlos

Investigators

  • Study Director: Laura Ceballos, Full Professor, DDS, PhD, Universidad Rey Juan Carlos
  • Study Director: Victoria Fuentes, Associate Professor, DDS, PhD, Universidad Rey Juan Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

April 6, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 6, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100120240392024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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