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

NCT03792217 | Completed

• 1 other identifier: ENDO-CU-2011-7-25
• Study Type: interventional
• Target: 308
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Pulp Necrosis

Outcome Measures

Primary Outcomes (6)

• Postoperative pain using a pain-measuring scale

  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

  immediately after treatment

• Postoperative pain using a pain-measuring scale

  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 hours

• Postoperative pain using a pain-measuring scale

  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

  24 hours

• Postoperative pain using a pain-measuring scale

  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

  48 hours

• Postoperative pain using a pain-measuring scale

  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

  7 days

• Postoperative pain using a pain-measuring scale

  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.

  immediately after obturation

Secondary Outcomes (2)

• Sham medication intake incidence

  7 days

• Analgesic medication intake incidence

  7 days

Study Arms (2)

1.3% NaOCl

EXPERIMENTAL

Root canal irrigation done using 1.3% NaOCl.

Other: 1.3% NaOCl

5.25% NaOCl

ACTIVE COMPARATOR

Root canal irrigation done using 5.25% NaOCl.

Other: 5.25% NaOCl

Interventions

1.3% NaOCl OTHER

Endodontic irrigant

Also known as: 1.3% sodium hypochlorite

1.3% NaOCl

5.25% NaOCl OTHER

Endodontic irrigant

Also known as: 5.25% sodium hypochlorite

5.25% NaOCl

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (3)

• Almeida G, Marques E, De Martin AS, da Silveira Bueno CE, Nowakowski A, Cunha RS. Influence of irrigating solution on postoperative pain following single-visit endodontic treatment: randomized clinical trial. J Can Dent Assoc. 2012;78:c84.

  PMID: 22985896 BACKGROUND

• Bashetty K, Hegde J. Comparison of 2% chlorhexidine and 5.25% sodium hypochlorite irrigating solutions on postoperative pain: a randomized clinical trial. Indian J Dent Res. 2010 Oct-Dec;21(4):523-7. doi: 10.4103/0970-9290.74225.

  PMID: 21187618 BACKGROUND

• Farzaneh S, Parirokh M, Nakhaee N, Abbott PV. Effect of two different concentrations of sodium hypochlorite on postoperative pain following single-visit root canal treatment: a triple-blind randomized clinical trial. Int Endod J. 2018 Jan;51 Suppl 1:e2-e11. doi: 10.1111/iej.12749. Epub 2017 Mar 6.

  PMID: 28134983 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Officials

• Suzan Amin, PhD

  Cairo University

  STUDY DIRECTOR

• Randa El-Boghdady, PhD

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: January 3, 2019
• Study Start: July 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 3, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share