Effect of Emergency Pulpotomy Versus Pulp Extirpation on Anesthetic Efficacy in Endodontic Treatment of Acute Pulpitis
Primary Purpose
Symptomatic Irreversible Pulpits
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
emergency pulpotomy
Sponsored by
About this trial
This is an interventional other trial for Symptomatic Irreversible Pulpits
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
emergency pulpotomy
complete pulp extirpation
Arm Description
intervention arm
control arm
Outcomes
Primary Outcome Measures
anesthetic efficacy
measured byVerbal rating scale (VRS),unit:Binary (success/failure)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04599244
Brief Title
Effect of Emergency Pulpotomy Versus Pulp Extirpation on Anesthetic Efficacy in Endodontic Treatment of Acute Pulpitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpits
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
emergency pulpotomy
Arm Type
Experimental
Arm Description
intervention arm
Arm Title
complete pulp extirpation
Arm Type
Active Comparator
Arm Description
control arm
Intervention Type
Other
Intervention Name(s)
emergency pulpotomy
Intervention Description
removal of coronal pulp
Primary Outcome Measure Information:
Title
anesthetic efficacy
Description
measured byVerbal rating scale (VRS),unit:Binary (success/failure)
Time Frame
During pulp extirpation and pulpotomy (30 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Emergency Pulpotomy Versus Pulp Extirpation on Anesthetic Efficacy in Endodontic Treatment of Acute Pulpitis
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