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

April 16, 2020 updated by: Cemre Sapmaz Uçan, Cukurova University

Effect of QMix 2-in-1 as Final Irrigation Protocol on Periapical Healing After Single-visit Root Canal Treatment: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial was conducted to evaluate radiographic periapical repair after endodontic treatment using QMix 2-in-1 (Dentsply Tulsa, Maillefer, Ballaigues, Switzerland) and NaOCl irrigation in single-rooted teeth with apical periodontitis.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Adana, Turkey, 01130
        • Çukurova University, Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • necrotic, single root teeth with a periapical lesion (2>PAI>5)

Exclusion Criteria:

  • pregnant
  • had used antibiotics within the previous week
  • allergy to local anesthetic agents
  • history of intolerance to non-steroidal anti-inflammatory drugs
  • had uncontrolled hypertension, uncontrolled diabetes mellitus, chronic renal failure, hematological disease, or had received or were receiving radiotherapy and periodontal bone loss (visualized radiographically)
  • open tooth apex

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
The root canal was prepared using the WaveOne Gold file reciprocation system with VDW Silver motor. WaveOne Gold #25 (0.07) file was used for instrumentation. For larger canals, #35 (0.06) and #45 (0.05) files were used after the #25 file. During instrumentation procedure, irrigation was applied with 5mL 2.5% NaOCl using a side-vented needles. The final irrigation was applied with 5mL NaOCl and 5mL sterile saline in the control group.The root canals were dried with sterile paper points and were filled with gutta-percha and AH Plus sealer with the cold lateral condensation method and the entry cavity was restored with composite. All treatments were performed following a standardized procedure by one operator. After completion of the root canal treatment, periapical radiographs were taken using the paralleling technique. All the patients were called for follow-up examination at 12 months, and were examined radiographically.
Experimental: QMix 2in1
The root canal was prepared using the WaveOne Gold file reciprocation system with VDW Silver motor. WaveOne Gold #25 (0.07) file was used for instrumentation. For larger canals, #35 (0.06) and #45 (0.05) files were used after the #25 file. During instrumentation procedure, irrigation was applied with 5mL 2.5% NaOCl using a side-vented needles. The final irrigation was applied with 5mL Mix 2in1 and 5mL sterile saline in the experimental group.
In QMix 2in1 group root canals were irrigated with Mix as a final irrigation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic healing after 12 months follow-up.
Time Frame: Time frame is 12 months for this study. Each patient will recall for an appointment and the status of the tooth will evaluate radiographically.
After the completion of treatment of both control and QMix 2in1 group, the status of periapical healing was assessed.
Time frame is 12 months for this study. Each patient will recall for an appointment and the status of the tooth will evaluate radiographically.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Oguz Yoldaş, Professor, University of Cukurova, Faculty of Dentistry, Vice-Dean

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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