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

Not Applicable

Completed

• Conditions: Dental Pulp Necrosis
• Interventions: Other: 5.25% NaOCl; Other: 1.3% NaOCl

• Registration Number: NCT03792217
• Lead Sponsor: Cairo University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2018-12
• Study First Submitted: 2018-12-24
• Study First Submitted QC: 2018-12-31
• Last Update Submitted: 2018-12-31
• Study First Posted: 2019-01-03
• Last Update Posted: 2019-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5.25% NaOCl	5.25% NaOCl	Root canal irrigation done using 5.25% NaOCl.
1.3% NaOCl	1.3% NaOCl	Root canal irrigation done using 1.3% NaOCl.

Primary Outcome Measures

Name	Time	Method
Postoperative pain using a pain-measuring scale	immediately after obturation	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 obturation.

Secondary Outcome Measures

Name	Time	Method
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.