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Clinical Trials in Turkey / NCT07241650
Active, not recruiting Not applicable

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

NCT07241650 · tracked via the Priya Life Science Turkey tracker
Sponsor
Ankara Yildirim Beyazıt University
Phase
Not applicable
Started
2025-11-01
Last updated
2025-11-21

Condition(s) studied

Irreversible Acute PulpitisRoot Canal Treatment

Investigational drug(s) / intervention(s)

Irrigation with Sodium Hypochlorite and Conventional SyringeIrrigation with Sodium Hypochlorite and EDDYProcedure: Irrigation with Sodium Hypochlorite and Diode LaserProcedure: Irrigation with Etidronic Acid and Conventional SyringeProcedure: Irrigation with Etidronic Acid and EDDYIrrigation with Etidronic Acid and Diode Laser

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.

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: 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: 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: 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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Systemic Inclusion Criteria1. Volunteers must not have any systemic symptoms or be pregnant.2. According to the ASA classification, individuals with: • ASA I (Healthy (without acute and/or chronic diseases)• ASA II (with mild systemic diseases) (asymptomatic congenital heart disease, well-controlled dysrhythmias, non-exacerbated asthma, well-controlled epilepsy, non-insulin-dependent diabetes mellitus, oncological conditions in remission) will be included in our study.3. Must be between 18 and 65 years of age.4. Must not have used analgesic anti-inflammatory drugs in the last two weeks or cortisone in the last 6 months.5. Volunteers must be able to contact us again 6, 12, 24, 48, or 72 hours after completing their treatment and must be mentally fit enough to express pain scores and answer the questionnaire.6. Volunteers must not have bruxism.Local inclusion criteria 1. Mandibular molars must be present.2. Teeth must be asymptomatic preoperatively.There must be no palpation, percussion, or radiographic findings.3. Rubber dams must be attached to the teeth to be treated.4. The teeth must be in its normal position within the mouth.5. The volunteer must be able to open their mouth sufficiently. Exclusion Criteria: * 1\. 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.

Primary outcome measure(s)

  • VAS scala — 6., 12.,24.,36.,48.,72 hours and 1 week
    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.
  • OHIP test — 7 days
    (OHIP14) Scale will be asked to be filled before treatment and one week after treatment.

Trial sites (1)

FacilityCityRegionStatus
Ankara Yıldırım Beyazıt Universty Ankara Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07241650 on ClinicalTrials.gov ↗ ← All trials in Turkey