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.

Apical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05582421
• Other study ID #: 1141821228
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 2022
• Est. completion date: August 2024

Study information

• Verified date: November 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apical Periodontitis
• Dental Pulp Necrosis
• Necrosis
• Necrotic Pulp
• Pain, Postoperative
• Periapical Periodontitis
• Periodontitis

Intervention

Drug:
• Diclofenac Sodium
intracanal medication

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Periapical MMP-9 level	determined post-instrumentation and pre-obturation by ELISA.	7 days
Primary	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	Bacterial load reduction	bacterial counting using agar culture technique after root canal preparation (CFU/ml).	7 days