A clinical trial to study effect of pretreatment submucosal dexamethasone injection on postoperative pain after endodontic therapy

Phase 4

Brief Summary: This study is the randomized, double blind, placebo controlled, single centered clinical trial evaluating the effect of pretreatment submucosal dexamethasone injection (8mg/2ml) on postoperative endodontic pain in patients (>18yrs) with symptomatic apical periodontitis secondary to irreversible pulpitis.

**PrimaryObjective:**

To determine the effect of dexamethasone submucosal injection on post-operativeendodontic pain at different time intervals of 6h, 12h, 24h, 48h and 72hours.

**SecondaryObjective:**

Thesecondary objective will be to assess any unscheduled appointment for emergencytreatment or any complications such as postoperative swelling.

**Null hypothesis**: There is no significant difference in thereduction of postoperative pain with pretreatment submucosal dexamethasoneinjection and saline injection.

**Primary Outcome Measures**:The effect of submucosalinjection of dexamethasone on postoperative pain in teeth with symptomaticapical periodontitis will bemeasured as the changes from baseline at 6h, 12h, 24h, 48h and 72 hours.

**Secondary OutcomeMeasures**: Any unscheduledappointment for emergency treatment or any complications such as postoperativeswelling will be measured.

Total estimated sample size would be 60.

Recruitment & Eligibility

Inclusion Criteria

Nepalese patients 18 years old or above.
Healthy persons (ASA I or II) Only patients presenting with decayed tooth with a diagnosis of symptomatic apical periodontitis with clinical history of lingering pain.
Patient who can understand and provide informed consent Patient who can rate pain according to numeric rating scale.

Exclusion Criteria

Patient not willing to participate in the study Patients whose forms will be incompletely or inadequately filled out Individuals who received any analgesic or anti-inflammatory drugs within the last 12 hours Pregnant and lactating women A history of medication for chronic pain Immunocompromised patient Patients under corticosteroids Patients with special needs and medical conditions altering the protocol Patients with history of sensitivity or adverse reactions to medicines to be used Root canal re-treatment Teeth with open apices, Root canals with an extreme curvature [>30Â°], Internal or external root resorption.
A radiographically untraceable canal path Any accident or complication occurring during treatment Anyone having the following diseases: tuberculosis, systemic fungal infections, simple ocular herpes, glaucoma, acute psychosis or psychotic tendencies.

Primary Outcome Measures

Name	Time	Method
The effect of submucosal injection of dexamethasone on postoperative pain in teeth with symptomatic apical periodontitis will be measured as the changes from baseline at 6h, 12h, 24h, 48h and 72 hours.	6 hours, 12 hours, 24 hours, 48 hours, 72 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Any unscheduled appointment for emergency treatment or any complications such as postoperative swelling will be measured.	Before 2nd appointment at 7th day

Locations (1): BP Koirala Institute of Health Sciences
🇮🇳
BPKIHS,Dharan-18,, India
BP Koirala Institute of Health Sciences
🇮🇳BPKIHS,Dharan-18,, India
Purna Prasad Sharma
Principal investigator
9847421219
purnaprasadsharma1@hotmail.com