Actively Recruiting
Effect of Apical Patency and Local Corticosteroid on Pain and Neuropeptides Release in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Led by Suez Canal University · Updated on 2024-06-13
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial studies patients with symptomatic acute irreversible pulpitis in molar teeth to evaluate how local corticosteroids and maintaining apical patency affect post-operative pain. The study aims to understand whether these approaches can reduce pain after root canal treatment by comparing groups that receive corticosteroids and/or apical patency to those that do not. Researchers will assess pain levels and inflammatory markers to answer this question. Participants receive root canal treatment and are randomly assigned to one of two groups: those who have apical patency maintained and those who do not. Additionally, participants receive either an infiltration injection of 0.7 ml of dexamethasone (a corticosteroid) or no corticosteroid injection after anesthesia. The study is single-blind and monitors effects over time. Participants will record their pain using a visual analogue scale at multiple time points after treatment: 6, 12, 24, 48, 72 hours, and 7 days. Inflammatory markers will also be measured before treatment, and then 3 days and 7 days afterward. The trial includes adults aged 21 to 60 with no medical conditions or contraindications for corticosteroids. The total study period includes these post-treatment follow-ups to capture pain and inflammation changes.
CONDITIONS
Brief Title
Effect of Apical Patency and Local Corticosteroid on Pain and Neuropeptides Release in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic acute irreversible pulpitis in molar teeth
- Normal periapical condition including periapical radiography with minimal widening of periodontal ligament
- Normal probing depth
- No medical condition
- No contraindication for administration of corticosteroids and local anesthesia
You will not qualify if you...
- Facial or oral paresthesia
- Pregnancy & breastfeeding
- Unrestorable tooth
- Marginal periodontal disease
- Presence of a crown on the tooth involved
- Over instrumentation during root canal treatment
- Long-term use of corticosteroids
- False-positive cases of sensibility test with necrosis discovered after gaining access to the tooth
- Cases requiring intrapulpal injection to promote anesthesia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive either an apical patency procedure or a sham procedure combined with a corticosteroid or non-corticosteroid injection after anesthesia administration.
1 treatment visit (in-person)
Duration - 7 days
Participants are monitored for post-operative pain and inflammatory markers at specified intervals after treatment.
Visits at 6, 12, 24, 48, and 72 hours and at 7 days post-treatment
Trial Site Locations
Total: 1 location
1
Suez Canal University
Ismailia, Egypt
Actively Recruiting
Research Team
M
Mustafa Sultan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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