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

NCT ID: NCT04599244

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-12-01

Brief Summary

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.

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.

Conditions

Symptomatic Irreversible Pulpits

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

emergency pulpotomy

intervention arm

Group Type: EXPERIMENTAL

emergency pulpotomy

Intervention Type: OTHER

removal of coronal pulp

complete pulp extirpation

control arm

Group Type: ACTIVE_COMPARATOR

emergency pulpotomy

Intervention Type: OTHER

removal of coronal pulp

Interventions

emergency pulpotomy

removal of coronal pulp

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nesma Ali

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

3-3-5

Identifier Type: -

Identifier Source: org_study_id