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

NCT07241650 | Active Not Recruiting

• 1 other identifier: 2025-13-19
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irreversible Acute Pulpitis; Root Canal Treatment

Keywords

root canal irrigation; irrigation activation systems; EDDY; laser

Outcome Measures

Primary Outcomes (2)

• VAS scala

  VAS (Visual Analog Scale): As its name suggests, the visual analog scale (VAS) uses an analog format, representing a continuous range of values. The most common way to measure pain on a VAS is with a 10 cm (100 mm) horizontal line. The volunteer is asked to place a mark on this line, which is then measured and recorded in millimeters or centimeters.According to the VAS scale, they will mark the pain they feel before treatment and after 6, 12, 24, 36, 48, 72 hours and 1 week (VAS) on the form.

  6., 12.,24.,36.,48.,72 hours and 1 week

• OHIP test

  (OHIP14) Scale will be asked to be filled before treatment and one week after treatment.

  7 days

Study Arms (6)

Sodium Hypochlorite and Conventional Syringe

EXPERIMENTAL

Each canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite delivered manually using a conventional syringe, without any additional activation technique.

Procedure: Irrigation with Sodium Hypochlorite and Conventional Syringe

Sodium Hypochlorite and EDDY

EXPERIMENTAL

Each canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite activated for 30 seconds using the EDDY sonic device.

Procedure: Irrigation with Sodium Hypochlorite and EDDY

Sodium Hypochlorite and Diode Laser

EXPERIMENTAL

Each canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite activated for 30 seconds using a diode laser.

Procedure: Procedure: Irrigation with Sodium Hypochlorite and Diode Laser

Etidronic Acid (HEDP) and Conventional Syringe

EXPERIMENTAL

Each canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of HEDP (Dual Rinse) solution delivered manually using a conventional syringe, without any additional activation technique

Procedure: Procedure: Irrigation with Etidronic Acid and Conventional Syringe

Etidronic Acid (HEDP) and EDDY

EXPERIMENTAL

Each canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of HEDP (Dual Rinse) solution activated for 30 seconds using the EDDY sonic device.

Procedure: Procedure: Irrigation with Etidronic Acid and EDDY

Etidronic Acid (HEDP) and Diode Laser

EXPERIMENTAL

Each canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of HEDP (Dual Rinse) solution activated for 30 seconds using a diode laser.

Procedure: Irrigation with Etidronic Acid and Diode Laser

Interventions

Irrigation with Sodium Hypochlorite and Conventional Syringe PROCEDURE

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.

Also known as: NaOCl activated with Conventional Syringe

Sodium Hypochlorite and Conventional Syringe

Irrigation with Sodium Hypochlorite and EDDY PROCEDURE

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.

Also known as: NaOCl activated with EDDY

Sodium Hypochlorite and EDDY

Procedure: Irrigation with Sodium Hypochlorite and Diode Laser PROCEDURE

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.

Also known as: NaOCl activated with Diode Laser

Sodium Hypochlorite and Diode Laser

Procedure: Irrigation with Etidronic Acid and Conventional Syringe PROCEDURE

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.

Also known as: HEDP with Conventional Syringe

Etidronic Acid (HEDP) and Conventional Syringe

Procedure: Irrigation with Etidronic Acid and EDDY PROCEDURE

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.

Also known as: HEDP with EDDY

Etidronic Acid (HEDP) and EDDY

Irrigation with Etidronic Acid and Diode Laser PROCEDURE

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.

Also known as: HEDP with diode laser

Etidronic Acid (HEDP) and Diode Laser

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \. Volunteers who have used analgesics, anti-inflammatory drugs, antibiotics, etc. that could alter pain and infection control in the last 12 hours.2. Subjects with a history of sensitivity or adverse reactions to any medication or material used in this study3. Teeth with calcified canals or severe periodontal disease4. Subjects with missing opposing or adjacent teeth5. Pregnant or breastfeeding female subjects6. Teeth requiring additional anesthesia methods (e.g., intrapulpal, intraligamentary, second block anesthesia, or additional local anesthetic agent) will be excluded from the study if anesthesia is insufficient.7. Teeth with apical lesions will not be included in the study.8. Teeth with root resorption will not be included in the study.9. Teeth requiring restorations such as endocrowns, onlays, overlays, or full crowns due to excessive material loss after root canal treatment will not be included in the study.Teeth with structural loss sufficient to require post-core application will be excluded.10. Teeth with untreated periodontitis and teeth or sites that have undergone surgical treatment within the last 6 months will not be included in the study.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım Beyazıt Universty

Ankara, Turkey (Türkiye)

Location

Related Publications (9)

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• Scrimshaw SV, Maher C. Responsiveness of visual analogue and McGill pain scale measures. J Manipulative Physiol Ther. 2001 Oct;24(8):501-4. doi: 10.1067/mmt.2001.118208.

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  PMID: 9332805 BACKGROUND

• Layton G, Wu WI, Selvaganapathy PR, Friedman S, Kishen A. Fluid Dynamics and Biofilm Removal Generated by Syringe-delivered and 2 Ultrasonic-assisted Irrigation Methods: A Novel Experimental Approach. J Endod. 2015 Jun;41(6):884-9. doi: 10.1016/j.joen.2015.01.027. Epub 2015 Mar 6.

  PMID: 25749254 BACKGROUND

• Tungsawat P, Arunrukthavorn P, Phuntusuntorn P, Opatragoon S, Sirirangsee P, Inklub S. Comparison of the Effect of Three Irrigation Techniques and Root Canal Preparation Size on Sodium Hypochlorite Penetration into Root Canal Dentinal Tubules. Int J Dent. 2021 Mar 31;2021:6612588. doi: 10.1155/2021/6612588. eCollection 2021.

  PMID: 33859692 BACKGROUND

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  PMID: 201012 BACKGROUND

MeSH Terms

Interventions

Therapeutic Irrigation; Sodium Hypochlorite; Lasers, Semiconductor; Etidronic Acid

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques; Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the bioistatician performing the data analysis will be blinded to group allocation. the cinician performing th treatments will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc prof

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)