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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Periapical Diseases

Intervention / Treatment
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* Other: QMix 2in1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>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<br>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. | Other: QMix 2in1<br>* In QMix 2in1 group root canals were irrigated with Mix as a final irrigation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic healing after 12 months follow-up. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QMix 2-in-1, Sodium hypochlorite, Chlorhexidine, Treatment outcome, Radiographic healing