Clinical Trial: Clinical and Microbiological Evaluation of 0.5% Versus 3% Sodium Hypochlorite in Root Canal Treatment
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Clinical and Microbiological Evaluation of 0.5% Versus 3% Sodium Hypochlorite in Root Canal Treatment
Brief 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.
Detailed Summary:
The aim of the present study is to compare the antimicrobial and immediate clinical effect of NaOCl 0.5% with the effect of NaOCl 3% in the endodontic treatment of teeth referred to the Specialist Clinic of Endodontics, Göteborg, Public dental Health, Västra Götaland. The efficiency of the treatment will be evaluated with sampling and cultivation methods and the assessment of patients' symptoms with a visual analogue scale.
The sample size calculation was performed with a type I error of 0.05 and statistical power of 80 %. The investigators expected 70 % of the samples to be free from bacteria growth in the control group and the investigators considered clinically relevant a difference of 15 % between the groups in order to demonstrate significant differences attributable to the experimental therapy used. The investigators want our sample size to be two hundred sixty four patients, 132 to each group.
A detailed explanation of the purpose of the study was given. Patients were also informed about the confidentiality of the data to be collected and about the voluntary participation. Every patient gets assigned a code that indicates which group they belong so the same irrigant is used in case of more than one visit.
Root canal treatment followed the standard principles of the Specialist Clinic of Endodontics, Göteborg, Public dental Health, Västra Götaland but the treatments were not restricted to a single protocol.
The recommended minimum or optimal apical size of canal preparation is size 25. All the operators are informed to perform the endodontic treatment the way operators normally do. The only variation during treatment was the concentration of the sodium hypochlorite solution for irrigation o
Sponsor: Göteborg University
Current Primary Outcome: Assessing bacterial growth in the root canal (positive meaning cultivable bacteria present, negative meaning absence of cultivable bacteria) [ Time Frame: Sample from the root canal taken immediately before root canal filling, assessing growth for 30 days after the sample is taken. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Assessment of post-operative pain using a questionnaire containing 7 visual scales. [ Time Frame: 7 consecutive days after each appointment ]
Original Secondary Outcome: Same as current
Information By: Göteborg University
Dates:
Date Received: January 26, 2016
Date Started: October 2014
Date Completion: April 2017
Last Updated: February 9, 2016
Last Verified: February 2016