CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 264 enrolled
Drug / intervention
Irrigation with 3% NaOCl +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02681276
NCT02681276N/ACompleted

Clinical and Microbiological Evaluation of 0.5% Versus 3% Sodium Hypochlorite in Root Canal Treatment

Göteborg University·interventional·Posted Feb 12, 2016·Updated Aug 6, 2018

In Brief

A clinical study evaluating Irrigation with 3% NaOCl and Irrigation with 0.5% NaOCl for Pulpitis and Apical Periodontitis. Completed, enrolled 264 participants across 1 site.

Detailed Summary

Aim: To compare the clinical antimicrobial and adverse effects of irrigation with Sodium Hypochlorite (NaOCl) 0.5% versus NaOCl 3% during root canal treatment. Methodology: Consecutive patients referred to a specialist clinic of endodontics are randomly assigned to have the root canal treatment performed with a concomitant irrigation either with a buffered 0.5 % NaOCl (Dakin's solution) or 3 % NaOCl. Teeth with vital or necrotic pulps and retreatment cases were included. Root canal treatment procedures varied but followed the routines of the Specialist Clinic of Endodontics, Public Dental Health, Gothenburg, Sweden. Immediately before the root canal filling a microbial sample is taken from the operative field and the root canal. The bacterial samples were processed at the laboratory as outlined by Möller (1966). After each visit each patient was instructed to fill in a questionnaire and assess his or her post-operative pain on a visual analogue scale (VAS), with endpoints 0= "no pain" and 10= "worst imaginable pain", for seven consecutive days. The Fischer's exact test was used for statistical analyses of the differences in outcome between the groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 12, 2016
Enrollment StartOct 1, 2014
Primary CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.4 years ago

Interventions

Irrigation with 3% NaOClprocedure

All the operators are informed to perform the endodontic treatment the way they normally do. The only variation during treatment was the concentration of the sodium hypochlorite solution for irrigation of the root canal.

Irrigation with 0.5% NaOClprocedure

All the operators are informed to perform the endodontic treatment the way they normally do. The only variation during treatment was the concentration of the sodium hypochlorite solution for irrigation of the root canal.