- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04348578
Effect of QMix 2in1 as Final Irrigation Protocol on Periapical Healing
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
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Adana, Turkey, 01130
- Çukurova University, Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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.
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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.
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In QMix 2in1 group root canals were irrigated with Mix as a final irrigation.
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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.
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After the completion of treatment of both control and QMix 2in1 group, the status of periapical healing was assessed.
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Time frame is 12 months for this study. Each patient will recall for an appointment and the status of the tooth will evaluate radiographically.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Oguz Yoldaş, Professor, University of Cukurova, Faculty of Dentistry, Vice-Dean
Publications and helpful links
General Publications
- Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26.
- Abbaszadegan A, Nabavizadeh M, Hoseini Yekani A, Khayat A. Comparison of Endodontic Treatment Results Yielded from Using Normal Saline with IKI Final Rinse or NaOCl Irrigation: A 30-Month Follow-up Study. Iran Endod J. 2013 Fall;8(4):171-6. Epub 2013 Oct 7.
- Holland R, Gomes JE Filho, Cintra LTA, Queiroz IOA, Estrela C. Factors affecting the periapical healing process of endodontically treated teeth. J Appl Oral Sci. 2017 Sep-Oct;25(5):465-476. doi: 10.1590/1678-7757-2016-0464.
- Pai S, Thomas MS. The effect of QMix, an experimental antibacterial root canal irrigant, on removal of canal wall smear layer and debris. J Endod. 2011 Jun;37(6):741; author reply 741-3. doi: 10.1016/j.joen.2011.04.006. Epub 2011 May 6. No abstract available.
- Chandrasekhar V, Amulya V, Rani VS, Prakash TJ, Ranjani AS, Gayathri Ch. Evaluation of biocompatibility of a new root canal irrigant Q Mix 2 in 1- An in vivo study. J Conserv Dent. 2013 Jan;16(1):36-40. doi: 10.4103/0972-0707.105296.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TDH-2017-8165
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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