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

NCT02681276 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2018-08-06

No results posted yet for this study

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.

Conditions

  • Pulpitis
  • Apical Periodontitis

Interventions

PROCEDURE

Irrigation with 3% NaOCl

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.

PROCEDURE

Irrigation with 0.5% NaOCl

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.

Sponsors & Collaborators

  • Göteborg University

    lead OTHER

Principal Investigators

  • Thomas Kvist, phD · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02681276 on ClinicalTrials.gov