Effect of Pretreatment Dexamethazone on Pain and Success of Nerve Block
A Comparative Evaluation of Effect of Dexamethazone on Postendodontic Pain and Success of Inferior Alveolar Nerve Block in Mandibular Molars With Symptomatic Irreversible Pulpitis
1 other identifier
interventional
32
1 country
1
Brief Summary
A Comparative Evaluation of the effect of pretreatment dexamethasone versus placebo on post-endodontic pain and success of inferior alveolar nerve block in Mandibular molars with symptomatic Irreversible Pulpitis: A Blinded Randomized Clinical Trial Therapeutic study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1 postoperative-pain
Started Jul 2017
Typical duration for early_phase_1 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2017
CompletedFirst Posted
Study publicly available on registry
June 27, 2017
CompletedStudy Start
First participant enrolled
July 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2018
CompletedJune 27, 2017
June 1, 2017
3 months
June 18, 2017
June 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative pain
Numerical rating scale
48 hours
Secondary Outcomes (1)
success of inferior alveolar nerve block
2 hours
Study Arms (2)
Drug dexamethasone
ACTIVE COMPARATORpreoperative single dose of dexamethasone 0.5 mg oral tablet given to patients before starting of root canal treatment by 30 minutes.
Placebo
PLACEBO COMPARATORPlacebo will be administrated to patients before stating of root canal treatment
Interventions
single dose of tablet 0.5 mg dexamethasone given to patients before starting of root canal treatment by 30 minutes or placebo
Eligibility Criteria
You may qualify if:
- Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
- Patients having symptomatic irreversible pulpitis in one of their mandibular molars
- Age range is between 20 and 50 years
- Patients who can understand the categorical tool (points) for measurement
- Patients able to sign informed consent
You may not qualify if:
- Patients with positive percussion test
- Patients having history of necrosis with or without apical pathosis
- Patients have sinus tract or fistula extraoral or intraoral
- Patients having active pain in more than one molar
- Patients who had taken analgesics in the 12 hours preceding the preparation.
- Complicating systemic disease
- Subjects with allergies and hypersensitivity to or unable to take dexamethasone
- Teeth with grade 2 or 3 mobility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry
Cairo, Manyal, 02, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Manar Hamouda, Professor
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- investigator
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
June 18, 2017
First Posted
June 27, 2017
Study Start
July 12, 2017
Primary Completion
October 12, 2017
Study Completion
July 7, 2018
Last Updated
June 27, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share