Postoperative Pain After Endodontic Irrigation Using 1.3% Versus 5.25% Sodium Hypochlorite

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03792217

Enrollment

308

Registered

2019-01-03

Start date

2011-07-31

Completion date

2015-01-31

Last updated

2019-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Pulp Necrosis

Brief summary

Detailed description

The aim of this prospective, randomized, clinical trial was to evaluate the effect of 1.3% sodium hypochlorite (NaOCl) concentration versus 5.25% NaOCl concentration on post-operative pain and medication intake in adult patients with pulp necrosis in mandibular molars. Medical and dental history was obtained from all participants in this trial and clinical and radiographic evaluation for teeth was recorded. Participants with pulp necrosis with or without apical periodontitis were included. After access cavity preparation, participants were randomly assigned to one of the following groups: experimental group (irrigation using 1.3% NaOCl) or control group (irrigation using 5.25% NaOCl ). Two-visit root canal treatment was performed with a week interval in between visits. Each patient received a 7-day diary to record postoperative pain and rescue medication intake. Post-operative pain was measured at the following time points: immediately , 3, 24, 48 hours and 7 days after the first visit and postobturation.

Interventions

OTHER1.3% NaOCl

Endodontic irrigant

OTHER5.25% NaOCl

Endodontic irrigant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 45 Years

Healthy volunteers

Inclusion criteria

1. Age: 25-45 year old. 2. Medically free. 3. Non-vital mandibular teeth (first or second molar) with or without apical periodontitis 4. No sex predilection

Exclusion criteria

1. Pregnant females. 2. History of allergy to any medication used in the study. 3. Preoperative premedication 12 hours before procedure. 4. Acute abscess cases. 5. Badly-decayed crown. 6. Retreatment cases

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain using a pain-measuring scale	immediately after treatment	Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured immediately after the first visit

Secondary

Measure	Time frame	Description
Sham medication intake incidence	7 days	Sham medication intake incidence (Yes/No) taken as an initial rescue medication in case of postoperative pain.
Analgesic medication intake incidence	7 days	Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026