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

ConditionNecrotic Pulp
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAhmed Hesham Abdelmohaimen Rezk

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Application of cold atmospheric plasma

    Other intervention

    root canal disinfection protocol

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Application of cold atmospheric plasmaExperimental treatment 1 intervention
Group B: 2.5% sodium hypochloriteActive comparator 1 intervention

Trial outcomes

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).

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

Secondary outcomes

1

MMP-9 level

Periapical MMP-9 level will be determined using the absorbance ELISA after access cavity preparation (S-1), after application of disinfection protocol (S-2) and after one-week pre-obturation (S-3) (Abdel-Hamid et al. 2024).

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

Other outcomes

Sponsors and contacts

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Ahmed Hesham Abdelmohaimen Rezk

Lead sponsor

Cairo University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: