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Completed

NCT Number: NCT03792217

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

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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Key information

Conditions

Dental Pulp Necrosis Dental Pulp Diseases Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant females.
  • History of allergy to any medication used in the study.
  • Preoperative premedication 12 hours before procedure.
  • Acute abscess cases.
  • Badly-decayed crown.
  • Retreatment cases

Treatment and study plan

1.3% NaOCl

Other

Endodontic irrigant

Other names: 1.3% sodium hypochlorite

5.25% NaOCl

Other

Endodontic irrigant

Other names: 5.25% sodium hypochlorite

Primary outcomes

  1. Postoperative pain using a pain-measuring scale

    Time frame: 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

  2. Postoperative pain using a pain-measuring scale

    Time frame: 3 hours

    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 3 hours after the first visit

  3. Postoperative pain using a pain-measuring scale

    Time frame: 24 hours

    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 24 hours after the first visit

  4. Postoperative pain using a pain-measuring scale

    Time frame: 48 hours

    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 48 hours after the first visit

  5. Postoperative pain using a pain-measuring scale

    Time frame: 7 days

    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 7 days after the first visit

  6. Postoperative pain using a pain-measuring scale

    Time frame: 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 outcomes

  1. Sham medication intake incidence

    Time frame: 7 days

    Sham medication intake incidence (Yes/No) taken as an initial rescue medication in case of postoperative pain.

  2. Analgesic medication intake incidence

    Time frame: 7 days

    Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 3, 2019
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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