Overview

Evaluation of Trans-mucosal Bio-adhesive Discs of Diclofenac Potassium on the Anesthetic Success and Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

Status:
Not yet recruiting
Trial end date:
2022-09-22
Target enrollment:
0
Participant gender:
All
Summary
The aim of the proposed study is to compare the effect of single dose of Diclofenac Potassium premedication as trans-mucosal bio-adhesive discs versus placebo on the effectiveness of the inferior alveolar nerve block and postoperative pain in patients with symptomatic irreversible pulpitis.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Cairo University
Treatments:
Diclofenac
Criteria
Inclusion Criteria:

- Patients who are free from any physical or mental handicapping condition with no
underlying systemic disease.

- Age between 18-50 years old.

- Males & Females.

- Mandibular permanent molar teeth with:

- Preoperative sharp pain.

- Positive response of pulp tissue to cold pulp tester (ethyl chloride spray ) and
electric pulp tester

- Normal periapical radiographic appearance or slight widening in lamina dura using
periapical index (PAI) score 1 as normal periapical structures or 2 as small
changes in bone structures.

- Patients' acceptance to participate in the trial.

- Patients who can understand pain scale and can sign the informed consent

Exclusion Criteria:

- Medically compromised patients: Pain levels and healing following treatment would be
compromised as these patients have shown higher incidence of pain and lower healing
rate.

- Pregnant women: Avoid radiation exposure, anesthesia, and medication.

- If analgesics have been administrated by the patient during the past 24 hours
preoperatively might alter their pain perception.

- Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed
tooth inducing subsequent irritation and inflammation.

- Teeth with necrotic pulp, acute periapical abscess and swelling: Need special
treatment steps, it could influence initiation and progression of postoperative pain.

- Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical
and/or periodontal therapy.

- No restorability: Hopeless tooth.

- Immature teeth.

- Radiographic evidence of external or internal root resorption vertical root fracture,
perforation, calcification.