NCT04348578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 8, 2020

Last Update Submit

April 16, 2020

Conditions

Periapical Diseases

Keywords

QMix 2-in-1Sodium hypochloriteChlorhexidineTreatment outcomeRadiographic healing

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

control group

NO INTERVENTION

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.

QMix 2in1

EXPERIMENTAL

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

Interventions

QMix 2in1OTHER

In QMix 2in1 group root canals were irrigated with Mix as a final irrigation.

QMix 2in1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University, Faculty of Dentistry

Adana, 01130, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 24171024RESULT

  • 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.

    PMID: 29069143RESULT

  • 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.

    PMID: 22892729RESULT

  • 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.

    PMID: 21787479RESULT

  • 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.

    PMID: 23349574RESULT

MeSH Terms

Conditions

Periapical Diseases

Condition Hierarchy (Ancestors)

Jaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth Diseases

Study Officials

  • Oguz Yoldaş, Professor

    University of Cukurova, Faculty of Dentistry, Vice-Dean

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asistant

Study Record Dates

First Submitted

April 8, 2020

First Posted

April 16, 2020

Study Start

February 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2019

Last Updated

April 17, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)