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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dental Pulp Necrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1.3% NaOCl

Root canal irrigation done using 1.3% NaOCl.

Group Type EXPERIMENTAL

1.3% NaOCl

Intervention Type OTHER

Endodontic irrigant

5.25% NaOCl

Root canal irrigation done using 5.25% NaOCl.

Group Type ACTIVE_COMPARATOR

5.25% NaOCl

Intervention Type OTHER

Endodontic irrigant

Interventions

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1.3% NaOCl

Endodontic irrigant

Intervention Type OTHER

5.25% NaOCl

Endodontic irrigant

Intervention Type OTHER

Other Intervention Names

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1.3% sodium hypochlorite 5.25% sodium hypochlorite

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No