NCT04348578

Effect of QMix 2in1 as Final Irrigation Protocol on Periapical Healing

Completed NA Last updated 17 April 2020

What this trial tests

NA trial testing QMix 2in1 in Periapical Diseases in 60 participants. Completed in 1 February 2019.

Timeline

1 February 2017

Primary endpoint
1 February 2018

1 February 2019

Quick facts

Lead sponsor	Cukurova University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	1 February 2017
Primary completion	1 February 2018
Estimated completion	1 February 2019
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• QMix 2in1

Conditions studied

• Periapical Diseases — all drugs for Periapical Diseases →

Sponsor

Cukurova University

Who can join

Adults 18 to 65, any sex, with Periapical Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Aim: To compare the 12-month radiographic outcome of root canal treatment with and without the additional use of QMix 2-in-1 (Dentsply Tulsa, Maillefer, Ballaigues, Switzerland) irrigation solution.

Methodology: The study included 60 single-rooted teeth with periapical radiolucency of 60 patients, randomized into two groups using randomized block design with block sizes of 10 patients in each. Root canals were prepared with WaveOne Gold files (Dentsply Sirona, Maillefer, Ballaigues, Switzerland) and irrigation was performed with 5 mL 2.5% sodium hypochlorite (NaOCl) using side-vented needles during instrumentation. The final irrigation protocol was performed using 5 mL 2.5% NaOCl (n= 30) or 5 ml QMix 2-in-1 (n=30). Then the root canals were irrigated with 5 mL of distilled water and filled with gutta-percha and AH Plus sealer (Dentsply Sirona), using the cold lateral compaction technique. The patients were recalled after 12 months and evaluated radiographically according to perapical index (PAI) scores. Pre and post-treatment PAI scores were compared and teeth were considered 'healthy' (PAI ≤ 2) or 'diseased' (PAI ≥ 3). The Mann Whitney U test was used to compare the differences between the post-operative and follow-up images of the treatment groups. The Wilcoxon signed rank test was applied to examine the changes in PAI score from baseline to the follow-up evaluation in each group.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.