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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04599244
Other study ID # 3-3-5
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date December 1, 2022

Study information

Verified date October 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 78
Est. completion date December 1, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
emergency pulpotomy
removal of coronal pulp

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary anesthetic efficacy measured byVerbal rating scale (VRS),unit:Binary (success/failure) During pulp extirpation and pulpotomy (30 minutes)