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NCT Number: NCT06918639

Effectiveness of Pulpotomy in Symptomatic Permanent Teeth With Deep Caries Lesions

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

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Key information

Conditions

Irreversible Pulpitis Pulpotomy of Permanent Molars

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rey Juan Carlos University

Alcorcón, Madrid, 28922, Spain

Location status: Recruiting

Location contact

Laura Ceballos, Full Professor

CONTACT

[email protected]

+34 667056606

Olga González-Castro, DDS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulpotomy

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

OLGA GONZÁLEZ-CASTRO, DDS

CONTACT

[email protected]

+34667938051

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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