Effectiveness of Pulpotomy in Symptomatic Permanent Teeth With Deep Caries Lesions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversidad Rey Juan Carlos
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Pulpotomy
Procedure/SurgeryVPT: 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
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: to determinate the success of partial and total pulpotomy in permanent teeth1 intervention
Trial outcomes
Primary outcomes
1
Success rate of the vital pulpt treatment
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.
Time frame
From the treatment to the one-year follow-up.Secondary outcomes
1
Patient satisfaction with vital pulp treatment
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.
Time frame
From enrollement to the first control visit, 7 days laterSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov