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

Periapical Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04348578
• Other study ID #: TDH-2017-8165
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: April 2020
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Periapical Diseases

Intervention

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

Locations

Country	Name	City	State
Turkey	Cukurova University, Faculty of Dentistry	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

References & 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 — View 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. — View Citation

Holland R, Gomes JE Filho, Cintra LTA, Queiroz ÍOA, 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.