NCT Number: NCT04654845
To evaluate in a comparative way the perception of the patient who comes with pain due to irreversible pulpitis in a tooth and who receives two types of treatment: complete pulpectomy (or control group) or pulpotomy (or experimental group).
Prospective randomized and multicenter study. It will be carried out in 4 centers of similar socio-professional characteristics, with the same operative protocol. On a significant sample of emergency patients with a concrete clinical manifestation of symptomatic irreversible pulpitis, one type of intervention or another will be performed randomly. The data will be collected by means of a visual numeric scale (NRS).
The null hypothesis is that both interventions provide the same reduction of pain in patients who present symptomatic irreversible pulpitis.
All the patients who come to one of the private centers with irreversible pulpitis and who meet the defined criteria for inclusion and exclusion will be selected.
The type of procedure that will be performed in the control group will be the complete removal of the pulp by means of a defined instrumentation technique, also called Pulpectomy. The procedure to be performed in the experimental group will be the removal of the pulp only at coronal level, also called Pulpotomy. The interventions will be assigned randomly and the "List Randomizer" (random.org) will be used for the randomization.
Looking for future studies?
Notify Me20 year–100 year
All sexes
Interventional
Not applicable
Clínica Dental 4, Ferrol, A Coruña, Spain
Clinical procedure will be the same in both groups with regard to the anesthetic technique, and the cavity access and provisional closure of the aperture. The characteristics of both interventions will be described in detail in order to homogenize the procedures. The patient will be conveniently informed before requesting his/her Informed Consent for his/her voluntary participation in the study. Their identification data will be treated in accordance with the provisions of Regulation (EU) 2016/679 of the European Parliament and Council of April 27, 2016, and the Organic Law 3/2018 of 5/12, currently in force, will remain in custody at the Center where they receive treatment and will not be shared by the other centers of the study.
The patient will not be aware of the type of procedure he has been assigned for and will express in a numerical scale according to his perception of the pain on 4 occasions: before starting treatment, at 8-12, 24 and 72 hours after treatment. Likewise, right after receiving the treatment, he will answer some questions related to the degree of comfort during the treatment and about his perception of the time of the intervention.
Data sheets will be collected and treated statistically.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Access to pulp chamber. Removal of the pulp chamber tissue. Use of Sodium Hypochlorite (5.25% NaCl) during the whole procedure and in the amount considered appropriate by each operator.
Wait until confirmation of absence of bleeding from the conducts. Placement of polytetrafluroethylene in pulp chamber. Placement of temporary filling. Reduction of the occlusal surface of the tooth until there is no contact with the articulating paper from 200μ.
Access to pulp chamber. Removal of the pulp chamber tissue. Use of Sodium Hypochlorite (5.25% NaCl) during the whole procedure and in the amount considered appropriate by each operator.
Establishment of working length by means of Electronic Apex Locator and a number 8 K file.
Access to all conducts with a number 10 K file. Rotary instrumentation with one reciprocating system up to working length and up to an apical diameter of 25.
Placement of polytetrafluroethylene in pulp chamber. No intermediate medication will be filled into the conducts.
Placement of temporary filling. Reduction of the occlusal surface of the tooth until there is no contact with the articulating paper from 200μ.
Time frame: Through study completion, an average of 1 year.
The patient's perception of the degree of post-operative pain following emergency treatment
Time frame: Through study completion, an average of 1 year.
The time it takes for each procedure.
Aula Dental Avanzada
Other
Patient Perception Between Two Emergency Treatments of Symptomatic Irreversible Pulpitis. A Randomized Multicenter Clinical Trial.
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.
Published trials that share one or more normalized conditions with this study.
NCT07658742
Dental Pulp Diseases, Healthy Pulp
Kütahya, Turkey (Türkiye)
View Trial DetailsNCT07702942
Irreversible Pulpitis, Pulpotomy
Rohtak, Haryana, India
View Trial DetailsNCT07679152
Irreversible Pulpitis, Regenerative Endodontic Procedures
Cairo, Egypt
View Trial DetailsNCT02417337
Irreversible Pulpitis, Neurologic Manifestations
Khartoum, Sudan
View Trial Details