A Comparative Evaluation of the Degree of Pain and MMP-9 Expression Following Instrumentation of Necrotic Pulps With Apical Periodontitis in One or Two Visits

NCT07101003 | Not Yet Recruiting

• 1 other identifier: 14422023517120
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized clinical trial compares postoperative pain and MMP-9 levels after root canal treatment of necrotic teeth with apical periodontitis, using either single-visit or two-visit instrumentation. The primary outcome is pain intensity measured at multiple intervals using a Visual Analogue Scale. The secondary outcome is the periapical expression of MMP-9 assessed via ELISA. The trial aims to determine whether treatment timing impacts inflammation and healing.

Conditions

Apical Periodontitis; Necrotic Pulps; Single Rooted Teeth

Keywords

necrotic pulps; root canal system; Enterococcus faecalis (E. faecalis); Microbioogy; pain; bacterial reduction; Matrix metalloproteinases (MMPs)

Outcome Measures

Primary Outcomes (1)

• Post instrumentation Pain

  Pain will be measured At 6,12, 24, 48 and 72 hours post instrumentation by Modified Visual Analogue Scale (VAS)

  At 6,12, 24, 48 and 72 hours post instrumentation

Secondary Outcomes (1)

• MMP-9 level

  pre-instrumentation & 1 week post-instrumentation

Study Arms (2)

Multiple instrumentation

ACTIVE COMPARATOR

root canal instrumentation will be done on two visits as a control

Procedure: multiple visit instrumentation

single instrumentation

EXPERIMENTAL

Root canal instrumentation will be done on one visits

Procedure: single visit instrumentation

Interventions

single visit instrumentation PROCEDURE

root canal instrumentation will be done on single visit treatment

single instrumentation

multiple visit instrumentation PROCEDURE

root canal treatment will be done on two visits

Multiple instrumentation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-40 years.
• Males/Females.
• Straight single canaled permanent teeth:
• Non-Vital pulps.
• Negative response to cold pulp tester (ethyl chloride spray\*).
• Absence of spontaneous pain.
• Chronic apical periodontitis with negative response to percussion
• Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2\*2 mm radiographically. The Periapical Index (PAI) score by Ørstavik is 2 or 3 (Ørstavik et al., 1986 43)
• Systemically healthy patients (ASA I or II)
• No anti-inflammatory or antibiotic medications taken in the past month
• Patients' acceptance to participate in the trial.
• Patients who can understand pain scale and can sign the informed consent (Appendix I).
• Patients' acceptance to participate in the trial.

You may not qualify if:

• Medically compromised patients having significant systemic disorders. (ASA III or IV).
• Teeth with swelling or fistulous tract.
• Teeth with acute or chronic periapical abscess.
• Mobility Grade II or III.
• Previous root canal therapy.
• Non-restorable teeth.
• Immature teeth.
• Pregnant females.

Sponsors & Collaborators

• Marwa Hisham Mohamed Salah Eldin: lead

MeSH Terms

Conditions

Periapical Periodontitis; Pain

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marwa Hisham Mohamed, MSc

CONTACT

00201007096807; Marwa_hisham@dentistry.cu.edu.eg

Maruim Hisham Eissa, MSc

CONTACT

00201001714432; Mariam.abdelfattah@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: August 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 4, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share