Comparison of Post-operative Pain and Levels of MMP -9 Following Root Canal Irrigation With Sodium Hypochlorite Versus Cold Atmospheric Plasma in Patient With Necrotic Single Rooted Teeth: Randomized Clinical Trial

NCT07747753 | Not Yet Recruiting DMC

• 1 other identifier: 14422022531810
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effect of cold atmospheric plasma versus sodium hypochlorite as irrigating solutions in necrotic single rooted teeth. The main questions it aims to answer are:

• Does the use of sodium hypochlorite solution or cold atmospheric plasma as root canal irrigant will have the same effect on the level of postoperative pain in necrotic single rooted teeth?
• Does the use of sodium hypochlorite solution or cold atmospheric plasma as root canal irrigant will have the same effect on the level of MMP -9 in necrotic single rooted teeth? Researchers will compare cold atmospheric plasma to sodium hypochlorite solution as root canal irrigant to see if cold atmospheric plasma works to have the same effect on the level of postoperative pain and levels of MMP -9 in necrotic single rooted teeth. Participants will:
• be asked to rate their pain level according to the given instructions and will be asked to return for follow up after 2 days to hand the pain scale chart.
• be instructed to call the operator and will be permitted to take Ibuprofen 400 mg not more than 6 hours apart and to record their tablet intake within 48 hours postoperatively, in case of severe or persistent pain.
• be referred to the fixed prosthodontics department for final restoration.

Conditions

Necrotic Pulp

Keywords

cold atmospheric plasma; post-operative pain; necrotic pulp; sodium hypochlorite; MMP

Outcome Measures

Primary Outcomes (1)

• Post-operative pain

  Postoperative pain intensity will be measured at 6, 12, 24 and 48 hours and one week after the two visits following disinfection protocol in the first visit and after obturation in the second visit: Each patient will receive a pain chart containing 4 numerical rating scales; one for each time interval. The patient will be instructed to rate his/her pain level at the corresponding time interval on a scale from zero to 10, where a score of zero indicates absence of pain, a score from 1 to 3 indicates mild pain, a score from 4 to 6 indicates moderate pain and a score from 7 to 10 indicates severe pain (Youssif et al. 2025).

  6,12,24,48 hours and 7 days postoperative following the two visits.

Secondary Outcomes (1)

• MMP-9 level

  After access cavity preparation (S-1), after application of disinfection protocol (S-2) & after one-week pre-obturation (S-3)

Study Arms (2)

Application of cold atmospheric plasma

EXPERIMENTAL

root canal disinfection protocol

Other: Application of cold atmospheric plasma

2.5% sodium hypochlorite

ACTIVE COMPARATOR

irrigation solution

Other: Application of cold atmospheric plasma

Interventions

Application of cold atmospheric plasma OTHER

root canal disinfection protocol

2.5% sodium hypochlorite; Application of cold atmospheric plasma

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients in good physical health; American Society of Anesthesiologists (ASA) class I or II, with no known allergic manifestations to the drugs used in the study and no involvement with other medication during the study (Appendix)
• Patient's age between 18-55 years.
• Male and female patients.
• Patients who can understand the numerical rating scale (Appendix 4).
• Patients who accept to participate in the trial and can sign the informed consent (Appendix 1).
• Mature mandibular premolar teeth with:
• Negative response to electric pulp tester.
• No intra-canal calcifications or internal resorptive lesions.

You may not qualify if:

• Medically compromised patients having substantive functional limitations (ASA III or IV) (Appendix 2).
• Patients having two or more adjacent teeth requiring endodontic treatment.
• Patients who received antibiotic therapy within the last three months before treatment (Rôças et al., 2016).
• Patients administered analgesics in the last 24 hours before treatment.
• Teeth with:
• Vital pulps.
• Immature apices.
• Acute periapical abscess, swellings and facial cellulitis.
• Periodontally affected (mobility grade II or III).
• Previous root canal treatment.
• Non-restorable coronal portion.
• TMJ problems, bruxism or traumatic occlusion.
• Inability to perceive the given instructions.

Sponsors & Collaborators

• Ahmed Hesham Abdelmohaimen Rezk: lead

Study Sites (1)

Faculty of dentistry, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Necrosis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Manar Yosri Fouda, Professor

CONTACT

002 01001101108; manaryfouda@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The microbiologist will be blinded to the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)