NCT07241650

Evaluation of the Effects of Different Irrigation Solutions and Activation Methods on Postoperative Pain and Quality of Life in Root Canal Treatment

Postoperative Pain and Quality of Life in Root Canal Treatment: Prospective Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Ankara Yildirim Beyazıt University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Brief Summary: This prospective randomized controlled clinical trial aims to evaluate the effects of different irrigation solutions (NaOCl, HEDP) and activation methods (conventional syringe irrigation, EDDY, diode laser) on postoperative pain and oral health-related quality of life in single-visit root canal treatment of asymptomatic mandibular molars.

Detailed description

The primary aim of this prospective randomized controlled clinical trial is to evaluate the effects of two different irrigation solutions (2.5% NaOCl and HEDP) and three different activation methods (conventional syringe, EDDY, diode laser) on postoperative pain and oral health-related quality of life in single-visit root canal treatment of asymptomatic mandibular molars, aiming to overcome the limitations of conventional irrigation. Additionally, the study will compare patients' oral health-related quality of life before treatment and one week after treatment. While no significant difference in postoperative pain is expected, an improvement in quality of life is anticipated.Eligible participants will be adult patients requiring endodontic treatment of asymptomatic mandibular molars. After meeting inclusion criteria and providing informed consent, participants will be randomly assigned to six different groups. Randomization will be performed using a computer-generated random number sequence and the codes will be kept in sealed opaque envelopes to prevent bias between groups.The irrigation protocols and activation methods to be applied in the study are as follows:Irrigation Solutions: 2.5% NaOCl and HEDP (HEDP; Dual Rinse, Medcem GmbH, Weinfelden,Switzerland)Activation Techniques: Conventional syringe, EDDY (Micron, Tokyo, Japonya), diode laser Dentsply Sirona Sirolaser Advance; Sirona Dental Systems, Bensheim, Germany)Anesthesia: Regional mandibular block using Articaine-containing MaxicainAll procedures will be performed under rubber dam isolation. Root canal working length will be determined using a #10 K-type file and apex locator, and canals will be shaped using a nickel-titanium rotary system. Each canal will be irrigated according to the assigned protocol, and root canals will be obturated using gutta-percha and an epoxy resin-based sealer with a single-cone technique. Postoperative radiographs will be taken to confirm obturation, and definitive restorations will be completed with composite resin materials.Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 6, 12, 24, 36, 48, 72 hours, and one week after treatment. Quality of life will be measured using the OHIP-14 questionnaire before treatment and one week postoperatively.The study sample size is 90 participants, with 15 volunteers per group. All treatments will be performed by a single operator, and the materials and devices used in the study are standard products routinely used in clinical practice. The expected benefit of the study is to determine the effects of different irrigation solutions and activation methods on postoperative pain and patient quality of life, providing insights for clinical practice.

Conditions

• Irreversible Acute Pulpitis
• Root Canal Treatment

Interventions

Type	Name	Description
PROCEDURE	Irrigation with Sodium Hypochlorite and Conventional Syringe	Procedure: Irrigation with Sodium Hypochlorite and Conventional SyringeIn the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite delivered manually using a standard needle without any additional activation technique. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life.
PROCEDURE	Irrigation with Sodium Hypochlorite and EDDY	Procedure: Irrigation with Sodium Hypochlorite and EDDYSodium hypochloride with EDDY Activation In the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite, which will be activated with EDDY for 10 seconds. Each canal will receive three cycles of 10-second EDDY activation. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life.
PROCEDURE	Procedure: Irrigation with Sodium Hypochlorite and Diode Laser	Procedure: Irrigation with Sodium Hypochlorite and Diode LaserSodium Hypochloride with Diode Laser Activation In the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite, which will be activated with a diode laser for 10 seconds. Each canal will receive three cycles of 10-second laser activation. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life.
PROCEDURE	Procedure: Irrigation with Etidronic Acid and Conventional Syringe	Procedure: Irrigation with Etidronic Acid and Conventional SyringeEtidronic Acid with Conventional Syringe In the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite mixed with HEDP, delivered manually using a standard needle without additional activation. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life.
PROCEDURE	Procedure: Irrigation with Etidronic Acid and EDDY	Etidronic Acid with EDDY Activation In the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite mixed with HEDP, which will be activated with EDDY for 10 seconds. Each canal will receive three cycles of 10-second EDDY activation. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life.
PROCEDURE	Irrigation with Etidronic Acid and Diode Laser	Etidronic Acid with Diode Laser Activation In the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite mixed with HEDP, which will be activated with a diode laser for 10 seconds. Each canal will receive three cycles of 10-second laser activation. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: Turkey (Türkiye)