Pulpitis - Irreversible
Conditions
Keywords
Endodontic pain, NSAIDS, postoperative pain
Brief summary
This randomized controlled trial investigated whether a single dose of diclofenac sodium taken before a root canal procedure can reduce pain in the hours following the treatment. 160 patients with tooth pain from irreversible pulpitis were divided into two groups. One group received 100mg of diclofenac sodium 30 minutes before their procedure, while the other group received no pretreatment. Pain levels were measured at 6, 12, and 24 hours after the procedure. The study found that patients who took diclofenac before treatment were significantly more likely to be pain-free at 6 and 12 hours after the procedure compared to those who did not.
Detailed description
This was a parallel-arm, randomized controlled trial conducted in the Department of Operative Dentistry, Saidu College of Dentistry. A total of 160 patients aged 20-60 years with a diagnosis of irreversible pulpitis in vital teeth were enrolled via consecutive sampling. Participants were randomized using a computer-generated sequence with allocation concealment via sealed opaque envelopes. The experimental group (n=80) received a single oral dose of 100 mg diclofenac sodium 30 minutes prior to endodontic treatment. The control group (n=80) received no pretreatment medication. All endodontic treatments were performed by experienced operators using a standardized protocol. The primary outcome was postendodontic pain intensity, assessed using a Visual Analogue Scale (VAS) and categorized as none, mild, moderate, or severe. Pain levels were recorded via structured telephone interviews at 6, 12, and 24 hours post-treatment. Statistical analysis was performed using R software, with group comparisons made using the chi-square test.
Interventions
PROCEDUREPre treatment with NSAIDS
Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.
PROCEDURENo pretreatment with NSAIDS.
Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.
Sponsors
College of Physicians and Surgeons Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Pakistani nationals aged 20-60 years. Diagnosis of irreversible pulpitis in a vital tooth (single or multi-rooted), confirmed by a positive cold test. No evidence of periapical abscess on radiographs. -
Exclusion criteria
Prior use of analgesics within a specified timeframe Presence of periodontal disease. Current use of prophylactic antibiotics. Pregnancy or lactation. Mental disabilities. Systemic illnesses contraindicating endodontic therapy. Known hypersensitivity or adverse reaction to NSAIDs. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postendodontic Pain | 6 hours after endodontic treatment | Proportion of patients reporting no pain, mild pain, moderate pain, or severe pain as measured on a Visual Analogue Scale (VAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postendodontic Pain | 12 hours after endodontic treatment | Proportion of patients reporting no pain, mild pain, moderate pain, or severe pain as measured on a Visual Analogue Scale (VAS). |
Countries
Pakistan
Outcome results
None listed