Effect of Diclofenac Sodium Versus Calcium Hydroxide as Intracanal Medication on the Intensity of Postoperative Pain, Bacterial Load Reduction and MMP-9 Levels in Patients With Necrotic Pulp.

Effect of Diclofenac Sodium Versus Calcium Hydroxide as Intracanal Medication on the Intensity of Postoperative Pain, Bacterial Load Reduction and MMP-9 Levels in Patients With Necrotic Pulp: A Randomized Clinical Trial

the aim of this study is to compare the effect of using Diclofenac Sodium Versus Calcium Hydroxide as Intracanal medication on intensity of postoperative pain, bacterial load reduction after root canal preparation and periapical matrix metalloproteinase 9 level (MMP-9) post-instrumentation and pre-obturation in teeth with necrotic pulp

Study Overview

• Status: Not yet recruiting
• Conditions: Apical Periodontitis; Necrotic Pulp
• Intervention / Treatment: Drug: Diclofenac Sodium

Detailed Description

To compare the effect of diclofenac sodium versus calcium hydroxide as intra canal medication on:

- Primary Outcome Intensity of postoperative pain will be measured using numerical rating scale (NRS) at 6, 12, 24 and 48- hours post-instrumentation and at 6, 12, 24 and 48 hours post-obturation.

Secondary Outcome 1 Bacterial load reduction will be determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml).

Secondary Outcome 2 Periapical MMP-9 level will be determined post-instrumentation and pre-obturation by ELISA.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Early Phase 1

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:

-

Inclusion criteria:

• Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
• Age between 18-50 years.
• Males & Females.

• Mandibular single rooted permanent premolar teeth:

  • Diagnosed clinically with pulp necrosis.
  • Absence of spontaneous pain.
  • Positive pain on percussion denoting apical periodontitis.
  • Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2*2 mm radiographically.
• Patients' acceptance to participate in the trial.
• Patients who can understand pain scale and can sign the informed consent

Exclusion Criteria:

• Medically compromised patients
• Pregnant women.
• If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
• Patients reporting bruxism or clenching.
• Teeth that show association with acute periapical abscess and swelling.
• Greater than grade I mobility or pocket depth greater than 5mm.
• Non-restorable teeth
• Teeth with vital pulp.
• 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: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: calcium hydroxide; calcium hydroxide will be placed as intracanal medication between visits.	Drug: Diclofenac Sodium; intracanal medication
Active Comparator: diclofenac sodium; diclofenac sodium will be placed as intracanal medication between visits	Drug: Diclofenac Sodium; intracanal medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Intensity of postoperative pain	measured using numerical rating scale (NRS) at 6, 12, 24 and 48- hours post-instrumentation and at 6, 12, 24 and 48 hours post-obturation.	6,12.24.48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial load reduction	bacterial counting using agar culture technique after root canal preparation (CFU/ml).	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periapical MMP-9 level	determined post-instrumentation and pre-obturation by ELISA.	7 days

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: necrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Dental Pulp Diseases; Periapical Diseases; Pain, Postoperative; Periodontitis; Necrosis; Periapical Periodontitis; Dental Pulp Necrosis; 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: 1141821228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No