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Clinical Trials/NCT07755306
NCT07755306CompletedPhase 4

Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis After Using Dexamethasone in Combination With Local Anesthesia by Two Different Techniques (Randomized Clinical Trial)

Ain Shams University1 site in 1 country66 target enrollmentStarted: March 26, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
66
Locations
1
Primary Endpoint
visual analogue score (VAS) from 0 to 10

Study Overview

Brief Summary

The aim of this randomized clinical trial to evaluate the effect of dexamethasone in two different techniques on postoperative pain by dividing patients randomly into three groups:

  • Group I: buccinator injection of dexamethasone.
  • Group II: buccal infiltration of dexamethasone.
  • Group III (Control): IANB using local anesthesia only post operative pain will be evaluated subjectively by patients by VAS score after procedure immediately and follow up for 12, 24 and 72 hours and frequency of analgesic intake

Detailed Description

the previous studies used dexamethasone with LA to prolong the duration of nerve block , Dexamethasone is used in reducing intraoperative endodontic pain the study main aim is to overcome the problem of severe postoperative pain after endodontic treatment in patients with acute irreversible pulpitis by evaluating the effect of dexamethasone in two different techniques by giving dexamethasone injection of buccinator muscle, or dexamethasone as buccal infiltration, and comparing the results with inferior alveolar nerve block using local anesthesia only. pain score evaluated using VAS score preoperatively and postoperatively with different anesthetic techniques after endodontic treatment.and their effet on frequency of analgesic intake

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Both genders
  • •Older than age of (18 to 60) years
  • •Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study
  • •Having a mandibular molar tooth with vital pulp
  • •These patients were also suffering from symptomatic irreversible pulpitis ,intermittent or continuous sharp pain that lasts longer after removal of the stimulus
  • •Patients with moderate to severe symptoms VAS≥4

Exclusion Criteria

  • •Vulnerable group; pregnant females, mentally ill and diseased patientsetc.…
  • •Patients irritable to local anesthesia
  • •Patients who are supposed to take plain anesthesia
  • •Use of analgesic or antibiotic within 6 hours before the visit
  • •Absence of bleeding in the pulp chamber during cavity preparation
  • •Severe periodontal disease b- Patients' randomization, allocation and blinding:

Arms & Interventions

control

No Intervention

no intervention

buccinator injected by DEX drug

Active Comparator

patients will receive dexamethasone(2ml/8mg) 1ml per 30 sec slow injection at buccinator muscle as single injection preoperatively

Intervention: dexamethasone 8mg (Drug)

buccal infiltration by DEX drug

Active Comparator

buccal infiltration of dexamethasone (8mg/2ml) as single injection preoperative

Intervention: dexamethasone 8mg (Drug)

Outcomes

Primary Outcomes

visual analogue score (VAS) from 0 to 10

Time Frame: postoperative 72 hours

VAS preoperative ,immediately postoperative,12hrs,24hrs,72hrs

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Salma Medhat

MSc Student

Ain Shams University

Study Sites (1)

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