Effect of Emergency Pulpotomy Versus Pulp Extirpation on Anesthetic Efficacy in Endodontic Treatment of Acute Pulpitis

Assessment of the Effect of Emergency Pulpotomy Versus Complete Pulp Extirpation on Anesthetic Efficacy in Endodontic Treatment of Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful, and one of the main reasons for seeking emergency dental treatment. Pain associated with irreversible pulpitis represents more than 45% of emergency patients in dental clinics. A pulpotomy has been demonstrated as an emergency intervention for effective pain relief by removing the coronal pulp tissue without penetrating radicular pulpal tissue. Inflammation and degeneration of the pulp usually progress apically from the point of infection, so selective removal of this tissue in the form of pulpotomy is usually effective in controlling pain and patient sedation.

The rationale behind emergency pulpotomy is relieving acute dental pain caused by irreversible pulpitis. However, there is still insufficient evidence to determine whether the presence, nature and duration of clinical symptoms gives accurate information about the extent of pulp inflammation, as pulpotomy was found to be an effective emergency treatment strategy with respect to relieving clinical symptoms, even in cases of irreversible pulpitis with symptomatic apical periodontitis . Advanced diagnostic strategies are needed to determine whether there is a correlation between clinical symptoms, actual pulpal inflammation and achieving adequate pain relief during and after treatment. Thus, we are conducting this study to assess the effect of emergency pulpotomy versus complete pulp extirpation on relieving acute dental pain of symptomatic irreversible pulpitis in mandibular molars. The expected benefit for the patients is to decrease pain during and after treatment. we also are trying to provide an evidence for the clinician in order to provide the best endodontic treatment without pain.

Study Overview

• Status: Unknown
• Conditions: Symptomatic Irreversible Pulpits
• Intervention / Treatment: Other: emergency pulpotomy

Detailed Description

Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful, and one of the main reasons for seeking emergency dental treatment. Pain associated with irreversible pulpitis represents more than 45% of emergency patients in dental clinics. A pulpotomy has been demonstrated as an emergency intervention for effective pain relief by removing the coronal pulp tissue without penetrating radicular pulpal tissue. Inflammation and degeneration of the pulp usually progress apically from the point of infection, so selective removal of this tissue in the form of pulpotomy is usually effective in controlling pain and patient sedation.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are medically free from any systemic disease that may contra indicate our interventions.
• Patient's age between 18-65 years old.
• Mandibular molar having vital pulps with symptomatic irreversible pulpitis because this group of patients may have more endodontic pain
• Positive patient's acceptance for participation in the study.

Exclusion Criteria:

• - Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment to give true response of pain during treatment.
• Teeth with necrotic pulp.
• Pregnant patients or lactating because of radiographic hazards and use of analgesics.
• Any known sensitivity or adverse reactions to ibuprofen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: emergency pulpotomy; intervention arm	Other: emergency pulpotomy; removal of coronal pulp
Active Comparator: complete pulp extirpation; control arm	Other: emergency pulpotomy; removal of coronal pulp

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anesthetic efficacy	measured byVerbal rating scale (VRS),unit:Binary (success/failure)	During pulp extirpation and pulpotomy (30 minutes)

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Emergencies; Pulpitis
• Other Study ID Numbers: 3-3-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

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