Patient Perception Between Two Emergency Treatments of Symptomatic Irreversible Pulpitis.

NCT04654845 | Completed DMC

• 1 other identifier: PULP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Irreversible Pulpitis

Keywords

Pulpotomy; Pulpectomy

Outcome Measures

Primary Outcomes (1)

• Patients´ pain perception

  The patient's perception of the degree of post-operative pain following emergency treatment

  Through study completion, an average of 1 year.

Secondary Outcomes (1)

• Procedure time

  Through study completion, an average of 1 year.

Study Arms (2)

Pulpotomy

EXPERIMENTAL

Only the tissue in the pulp chamber will be removed.

Procedure: Pulpotomy

Pulpectomy

ACTIVE COMPARATOR

Both the chamber´s and root´s pulp tissue will be removed up to a 25 gauge.

Procedure: Pulpectomy

Interventions

Pulpotomy PROCEDURE

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.

Pulpotomy

Pulpectomy PROCEDURE

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.

Pulpectomy

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient in American Society of Anesthesiologists I or II condition.
• Patient who comes to the emergency room with irreversible pulpitis in a single tooth.
• Patients of age \>20 years.
• Positive response to the vitality test and bleeding after pulp exposure.

You may not qualify if:

• American Society of Anesthesiologists patients\>II.
• Pharmacological allergies that contraindicate the intervention.
• Teeth with negative vitality test and no bleeding after pulp exposure.
• Signs of concomitant periodontal infection such as swelling or fistula.
• Teeth with immature roots.
• Patients who are medicated with anxiolytics.
• Abuse of psychotropic drugs or medication that may alter the perception of pain 15 days before the intervention.
• Pregnant or breast-feeding women.
• Interventions with conscious sedation.
• Pathological mental state (dementia, psychosis).
• Lack of collaboration or non-acceptance of the consent of the study.

Sponsors & Collaborators

• Aula Dental Avanzada: lead

Study Sites (4)

Clínica Dental 4

Ferrol, A Coruña, 15402, Spain

Location

Clínica Dental Corbalán

Ceutí, Murcia, 30562, Spain

Location

Centro Dental Navarro Ferri

Cullera, Valencia, 46400, Spain

Location

Clínica Dental esteve

Alicante, 03001, Spain

Location

Related Publications (7)

• Gatewood RS, Himel VT, Dorn SO. Treatment of the endodontic emergency: a decade later. J Endod. 1990 Jun;16(6):284-91. doi: 10.1016/S0099-2399(06)81631-6.

  PMID: 2074427 BACKGROUND

• Lee M, Winkler J, Hartwell G, Stewart J, Caine R. Current trends in endodontic practice: emergency treatments and technological armamentarium. J Endod. 2009 Jan;35(1):35-9. doi: 10.1016/j.joen.2008.10.007.

  PMID: 19084121 BACKGROUND

• Nyerere JW, Matee MI, Simon EN. Emergency pulpotomy in relieving acute dental pain among Tanzanian patients. BMC Oral Health. 2006 Jan 21;6:1. doi: 10.1186/1472-6831-6-1.

  PMID: 16426455 BACKGROUND

• Pak JG, White SN. Pain prevalence and severity before, during, and after root canal treatment: a systematic review. J Endod. 2011 Apr;37(4):429-38. doi: 10.1016/j.joen.2010.12.016.

  PMID: 21419285 BACKGROUND

• Eghbal MJ, Haeri A, Shahravan A, Kazemi A, Moazami F, Mozayeni MA, Saberi E, Samiei M, Vatanpour M, Akbarzade Baghban A, Fazlyab M, Parhizkar A, Ahmadi M, Akbarian Rad N, Bijari S, Bineshmarvasti D, Davoudi P, Dehghan R, Dehghani M, Ebrahimi H, Emami N, Farajian N, Fereidooni R, Ghobadi G, Ghodrati M, Gohari A, Hashemi A, Hosseini M, Karami E, Kheirabadi N, Kozegari S, Labaf Ghasemi H, Majidi A, Malekzadeh P, Mehrabi V, Mohammadi M, Moradi Eslami L, Noghani A, Omatali N, Pourhatami N, Rahbani Nobar B, Rahmani S, Shafaq P, Soofiabadi S, Teimoori S, Vatandoost F, Asgary S. Postendodontic Pain after Pulpotomy or Root Canal Treatment in Mature Teeth with Carious Pulp Exposure: A Multicenter Randomized Controlled Trial. Pain Res Manag. 2020 Jun 30;2020:5853412. doi: 10.1155/2020/5853412. eCollection 2020.

  PMID: 32676136 RESULT

• Eren B, Onay EO, Ungor M. Assessment of alternative emergency treatments for symptomatic irreversible pulpitis: a randomized clinical trial. Int Endod J. 2018 Apr;51 Suppl 3:e227-e237. doi: 10.1111/iej.12851. Epub 2017 Oct 16.

  PMID: 28857203 RESULT

• Oguntebi BR, DeSchepper EJ, Taylor TS, White CL, Pink FE. Postoperative pain incidence related to the type of emergency treatment of symptomatic pulpitis. Oral Surg Oral Med Oral Pathol. 1992 Apr;73(4):479-83. doi: 10.1016/0030-4220(92)90330-s.

  PMID: 1574311 RESULT

MeSH Terms

Interventions

Pulpotomy; Pulpectomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Guillem Esteve-Pardo, DDS

  Aula Dental Avanzada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will not be aware of the type of procedure he has been assigned for.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS

Model Details: Participants with irreversible pulpitis are randomly assigned to one type of intervention.

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 4, 2020
• Study Start: November 16, 2020
• Primary Completion: July 29, 2022
• Study Completion: July 30, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)