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.

Early Phase 1

Not yet recruiting

• Conditions: Apical Periodontitis; Necrotic Pulp
• Interventions: Drug: Diclofenac Sodium

• Registration Number: NCT05582421
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-17
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-10
• Study Start: 2022-12
• Primary Completion: 2023-10
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
calcium hydroxide	Diclofenac Sodium	calcium hydroxide will be placed as intracanal medication between visits.
diclofenac sodium	Diclofenac Sodium	diclofenac sodium will be placed as intracanal medication between visits

Primary Outcome Measures

Name	Time	Method
change in Intensity of postoperative pain	6,12.24.48 hours	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 Measures

Name	Time	Method
Bacterial load reduction	7 days	bacterial counting using agar culture technique after root canal preparation (CFU/ml).