An interventional study of commercially available Sodium Hypochlorite and Medical grade Sodium Hypochlorite in Symptomatic Irreversible Pulpitis (SIP), sponsored by Cairo University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
the aim of the current study is to evaluate the effects of commercial and medical formulations of NaOCl on postoperative pain after endodontic treatment of mandibular posterior teeth with acute irreversible pulpitis.
Personal data including name, address, and phone number in addition to medical history and dental history will be collected by the operator from each patient in specific forms, then history of chief complaint will be recorded. The selected patients should show symptoms of irreversible pulpitis. The operator will perform extra-oral and intra-oral clinical examination as the expected tooth to be included in this study should be examined tentatively using a diagnostic mirror and probe. Radiograph will be taken to help to identify if there is widening of periodontal ligament space, periapical radiolucency, deep caries near the pulp chamber or recurrent caries under restoration.
The diagnosis of symptomatic irreversible pulpitis is confirmed through the patients' history of moderate to severe pain with hot and/or cold in mandibular posterior area, prolonged exaggerated response to cold testing than the contralateral tooth and positive response to electric pulp tester. Radiograph should show no or slight widening of periodontal ligaments. After completing the diagnosis (symptomatic irreversible pulpitis) and confirming that the patient fulfills the eligibility criteria, the patient will be enrolled in the study. The treatment will be done in a single visit.
Patients will be referred to an operative or a fixed prosthodontics specialist for crown placement at the Faculty of Dentistry, Egyptian Russian University. Post-operative instructions and appropriate post-operative rescue medication will be prescribed (400mg Ibuprofen). All patients will be asked to record their postoperative pain level felt on NRS at 6, 12, 24, 48, 72 hours and 7 days.
Research objective (state the aim) The aim of this study is to assess the effect of different sodium hypochlorite preparations (commercial VS medical) on postoperative pain in patients with symptomatic irreversible pulpitis after single visit endodontic treatment.
Sample size:
Anticipated sample size, 60 patients will be included in the study, divided into 2 groups, 30 patients per group.
Grouping \& Randomization used:(specify if present) Two groups Group 1: Professional NaOCl Group 2: Commercial NaOCl
Outcome variables:
The primary outcome is the effect on Postoperative pain which will be measured using NRS at 6, 12, 24, 48, 72 hours postoperatively. Numerical Rating Scale (NRS) (20): It is an 11-point scale consisting of numbers from 0 through 10; - 0 reading represents "no pain" - 1-3 readings represent "mild pain" - 4- 6 readings represent "moderate pain" - 7- 10 readings represent "severe pain"
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
1. Pregnant females. 2. Patients taking pain medication 12 hours earlier. 3. Patient having more than one symptomatic mandibular tooth in the same quadrant.
4. Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
5. Patients with contributory medical history (ASA>II).
Drug: commercially available Sodium Hypochlorite
Drug: Medical grade Sodium Hypochlorite
during the routine root canal treatment of mandibular molars with SIP, irrigation will be performed between each two successive files with 2 ml of half concentration commercially available sodium hypochlorite and after complete preparation 5 ml of the same solution will be used in full concentration for the purpose of smear layer removal.
during the routine root canal treatment of mandibular molars with SIP, irrigation will be performed between each two successive files with 2 ml of half concentration Medical grade sodium hypochlorite and after complete preparation 5 ml of the same solution will be used in full concentration for the purpose of smear layer removal.
Post Operative pain
incidence and intensity of post operative pain after single visit root canal treatment of mandibular molars with SIP
Time frame: from enrollemnt to 72 hours after treatment
Plan to share: No
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Cairo University