Effects of Irrigation Activation Methods on Periapical Healing in Chronic Apical Periodontitis

NCT07850895 | Active Not Recruiting

• 1 other identifier: 2026/183
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of different irrigation activation methods on periapical healing in teeth with chronic apical periodontitis. Patients underwent root canal treatment using one of three irrigation activation methods: sonic activation, passive ultrasonic irrigation, or laser-activated irrigation. Periapical healing is evaluated by comparing baseline and follow-up periapical radiographs using the Periapical Index (PAI) and fractal analysis. PAI is used to assess changes in periapical status, while fractal dimension analysis is used to quantitatively evaluate changes in the trabecular bone structure in the periapical region. The study aims to determine whether the irrigation activation method used during root canal treatment influences subsequent periapical healing.

Conditions

Chronic Apical Periodontitis

Keywords

Periapical Healing; Irrigation Activation; Sonic Activation; Passive Ultrasonic Irrigation; Laser-Activated Irrigation; Periapical Index; Fractal Analysis; Root Canal Treatment

Outcome Measures

Primary Outcomes (2)

• Change in Periapical Index (PAI)

  Periapical healing will be assessed using the Periapical Index (PAI) on periapical radiographs. PAI scores range from 1 to 5, with lower scores indicating healthier periapical conditions and higher scores indicating greater severity of periapical pathology. Changes in PAI scores between baseline and follow-up radiographs will be evaluated.

  Baseline and at least 6 months after root canal treatment

• Change in Fractal Dimension (FD)

  Fractal dimension (FD) will be calculated from standardized regions of interest on periapical radiographs using ImageJ software and the box-counting method. Changes in FD values between baseline and follow-up radiographs will be evaluated to quantitatively assess changes in the trabecular bone structure in the periapical region.

  Baseline and at least 6 months after root canal treatment

Study Arms (3)

Sonic Activation

EXPERIMENTAL

Root canal treatment was performed using sonic activation for irrigation. The irrigating solutions were activated using a sonic activation device, with the activation tip positioned 2 mm short of the working length. Activation was performed for three 20-second cycles.

Device: Sonic Irrigation Activation

Passive Ultrasonic Irrigation

EXPERIMENTAL

Root canal treatment was performed using passive ultrasonic irrigation. The irrigating solutions were ultrasonically activated with the tip positioned 2 mm short of the working length. Activation was performed for three 20-second cycles.

Device: Passive Ultrasonic Irrigation

Laser-Activated Irrigation

EXPERIMENTAL

Root canal treatment was performed using Er:YAG laser-activated irrigation. Laser activation was performed from the coronal pulp chamber for three 20-second cycles.

Device: Laser-Activated Irrigation

Interventions

Sonic Irrigation Activation DEVICE

Irrigating solutions were activated using a sonic activation device. The activation tip was positioned 2 mm short of the working length, and sonic activation was performed for three 20-second cycles, for a total activation time of 60 seconds.

Sonic Activation

Passive Ultrasonic Irrigation DEVICE

Irrigating solutions were activated using a passive ultrasonic irrigation device in endodontic mode. The activation tip was positioned 2 mm short of the working length, and ultrasonic activation was performed for three 20-second cycles, for a total activation time of 60 seconds.

Passive Ultrasonic Irrigation

Laser-Activated Irrigation DEVICE

Irrigating solutions were activated using an Er:YAG laser with the following parameters: SSP mode (50 μs), 0.3 W, 15 Hz, and 20 mJ. A radial laser tip was positioned in the coronal pulp chamber, and activation was performed for three 20-second cycles, for a total activation time of 60 seconds.

Laser-Activated Irrigation

Eligibility Criteria

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

You may qualify if:

• Participants aged 18 years or older
• Systemically healthy participants
• Mandibular premolar teeth diagnosed with pulp necrosis and chronic apical periodontitis
• Teeth undergoing single-visit root canal treatment

You may not qualify if:

• Use of any analgesic medication within 24 hours before root canal treatment or use of corticosteroid medications
• Use of antibiotics within 1 week before root canal treatment
• Pregnancy or breastfeeding
• Presence of any systemic disease, including conditions requiring antibiotic prophylaxis
• Presence of mental or psychiatric disorders
• Presence of swelling or pain on palpation before treatment
• Presence of root resorption in the study tooth
• Presence of generalized periodontitis
• Presence of a periodontal pocket depth greater than 3 mm in the study tooth
• Teeth with root fracture, ankylosis, or pathological mobility
• Presence of a cystic lesion, defined as a lesion surrounded by a well-defined radiopaque border and causing displacement of adjacent teeth
• Teeth with radiographically very narrow or wide root canals
• Participants who did not attend the follow-up visit at least 6 months after root canal treatment

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, Rize Province, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 30, 2026
• Study Start: March 6, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)