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.

NCT05582421 | Unknown Early Phase 1

• 1 other identifier: 1141821228
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Necrotic Pulp; Apical Periodontitis

Keywords

necrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bacterial load reduction

  7 days

Other Outcomes (1)

• Periapical MMP-9 level

  7 days

Study Arms (2)

calcium hydroxide

SHAM COMPARATOR

calcium hydroxide will be placed as intracanal medication between visits.

Drug: Diclofenac Sodium

diclofenac sodium

ACTIVE COMPARATOR

diclofenac sodium will be placed as intracanal medication between visits

Drug: Diclofenac Sodium

Interventions

Diclofenac Sodium DRUG

intracanal medication

calcium hydroxide; diclofenac sodium

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Necrosis; Periapical Periodontitis; Necrosis

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: * In this proposed study, both the participant and assessor will be blinded. This is achieved where the outcome assessor will not be informed of the group in which the participant is enrolled for subjective outcomes. The participants will be blinded to the study hypothesis as to which intervention is expected to be better. * The patients who already do not know their treatment group will assess the level of their post-operative pain. * The laboratory technician at the microbiological department will not know the treatment group of the patients. * The treatment groups will remain anonymous at the end of the study during assessment by the statistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: Trial Design: Randomized Clinical Trial (Parallel Group) Two Arms Allocation Ratio: 1:1 Framework: Superiority

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 17, 2022
• Study Start: December 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: August 1, 2024
• Last Updated: November 10, 2022

Record last verified: 2022-11