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

Primary Purpose

Periapical Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
QMix 2in1
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Diseases focused on measuring QMix 2-in-1, Sodium hypochlorite, Chlorhexidine, Treatment outcome, Radiographic healing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cukurova University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

QMix 2in1

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 8, 2020
Last Updated
April 16, 2020
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT04348578
Brief Title
Effect of QMix 2in1 as Final Irrigation Protocol on Periapical Healing
Official Title
Effect of QMix 2-in-1 as Final Irrigation Protocol on Periapical Healing After Single-visit Root Canal Treatment: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

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

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Diseases
Keywords
QMix 2-in-1, Sodium hypochlorite, Chlorhexidine, Treatment outcome, Radiographic healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
QMix 2in1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
QMix 2in1
Intervention Description
In QMix 2in1 group root canals were irrigated with Mix as a final irrigation.
Primary Outcome Measure Information:
Title
Radiographic healing after 12 months follow-up.
Description
After the completion of treatment of both control and QMix 2in1 group, the status of periapical healing was assessed.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oguz Yoldaş, Professor
Organizational Affiliation
University of Cukurova, Faculty of Dentistry, Vice-Dean
Official's Role
Study Director
Facility Information:
Facility Name
Cukurova University, Faculty of Dentistry
City
Adana
ZIP/Postal Code
01130
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24171024
Citation
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.
Results Reference
result
PubMed Identifier
29069143
Citation
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.
Results Reference
result
PubMed Identifier
22892729
Citation
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.
Results Reference
result
PubMed Identifier
21787479
Citation
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.
Results Reference
result
PubMed Identifier
23349574
Citation
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.
Results Reference
result

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

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