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Completed

NCT Number: NCT04348578

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University, Faculty of Dentistry

Adana, 01130, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QMix 2in1

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 16, 2020
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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