Clinical trial NCT03792217: Postoperative Pain After Endodontic Irrigation Using 1.3% Versus 5.25% Sodium Hypochlorite
Official title: Postoperative Pain After Endodontic Irrigation Using 1.3% Versus 5.25% Sodium Hypochlorite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Pulp Necrosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 308
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain using a pain-measuring scale
timeFrame: immediately after treatment
measure: Postoperative pain using a pain-measuring scale
timeFrame: 3 hours
measure: Postoperative pain using a pain-measuring scale
timeFrame: 24 hours
measure: Postoperative pain using a pain-measuring scale
timeFrame: 48 hours
measure: Postoperative pain using a pain-measuring scale
timeFrame: 7 days
measure: Postoperative pain using a pain-measuring scale
timeFrame: immediately after obturation
Secondary outcomes:
measure: Sham medication intake incidence
timeFrame: 7 days
measure: Analgesic medication intake incidence
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Suzan Amin, PhD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Randa El-Boghdady, PhD
role: STUDY_CHAIR
References:
citation: 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.
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.
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.