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

Dental Pulp Necrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03792217
• Other study ID #: ENDO-CU-2011-7-25
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: January 2015

Study information

• Verified date: December 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Pain, Postoperative

Intervention

Other:
• 1.3% NaOCl
Endodontic irrigant
• 5.25% NaOCl
Endodontic irrigant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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