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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Irreversible Pulpitis
• Intervention / Treatment: Drug: Diclofenac Potassium

Detailed Description

One of the challenging goals of root canal therapy is to relieve the pain associated with irreversible pulp inflammation. Pain control especially in the early stages of treatment, is critical and can enhance the confidence of both the patient and the dentist. Irreversible pulpitis pain is sometimes difficult to be managed through the use of local anesthetics solely. Inadequate pain control during treatment may contribute to the development of peripheral and central sensitization leading to greater pain during recovery. Various mechanisms have been proposed to explain the failure of local anesthetics including anatomic variations such as; cross innervations and accessory innervations, tachyphylaxis of anesthetic solutions, and activation of nociceptors including tetrodotoxin (TTX).Strategies to control intra-operative endodontic pain include preoperative administration of analgesics, supplemental infiltrations, the use of different local anesthetic solutions, intra-osseous and periodontal injections, a repeat inferior alveolar nerve block. Prescribing drugs prior to treatment may enhance the patient's attitude and reduce the apprehension during endodontic therapy. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most common category of medications recommended for pain relief. They act by inhibition of prostaglandin synthesis by inhibition of cyclooxygenase pathway. Although, pulpectomy and removal of the inflamed pulpal tissues eliminates endodontic pain, post-operative pain and discomfort are common side effects. Many patients may still experience mild to extreme pain even after therapy. Diclofenac has shown a substantial reduction of post-endodontic pain when administered preoperatively in a single oral dose since it holds anti-inflammatory, antipyretic and analgesic effects. It acts primarily by inhibition of COX 1 and COX 2, thus inhibiting the prostaglandin synthesis. COX 1 is expressed throughout the body and has a role in protection of stomach mucosa, kidney function and platelet action. Numerous studies have clearly documented that the risk of upper gastrointestinal complications increases with increasing doses as well as increasing frequency of use. Additionally, when taken through oral route, only 50% of the absorbed dose of Diclofenac becomes available systematically, due to its first pass metabolism. Trans-mucosal drug delivery offers distinct advantages over oral administration such as avoiding hepatic first-pass metabolism, less dosing frequency, improved patient compliance, reduction in fluctuation in steady-state levels. In addition, there is a reduced intensity of local or systemic side effects, increased safety margin and maximum utilization of drug and reduction in the total amount of drug administered while achieving target delivery in odontogenic region.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single trans-mucosal bio-adhesive disc containing Diclofenac Potassium; Premedication 1 hour before starting endodontic treatment.	Drug: Diclofenac Potassium; The drug will be used as a transparent disc applied to the mucosa; Other Names: Cataflam
Placebo Comparator: Placebo Control; Premedication 1 hour before starting endodontic treatment. Identically-appearing trans-mucosal bio-adhesive disc (Does not contain medication)	Drug: Diclofenac Potassium; The drug will be used as a transparent disc applied to the mucosa; Other Names: Cataflam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of the inferior alveolar nerve block during cold test or any stage of access cavity preparation or instrumentation in patients with irreversible pulpitis.	the outcome will be measured with Heft-parker visual analogue scale (VAS) in which no or mild pain (Heft-Parker VAS rating less than 54mm) will be considered as anesthetic success and moderate or severe pain (Heft-parker VAS rating greater than 54mm) will be considered as anesthetic failure.	During endodontic treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of postoperative pain	the outcome will be measured using Heft-parker VAS	at 6, 12, 24, 48 hours after the end of endodontic treatment.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 21, 2021
• Primary Completion (Anticipated): September 21, 2022
• Study Completion (Anticipated): September 22, 2022

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Pulpitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: ENDO:3-5-5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No