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Chronic Apical PeriodontitisNCT07850895

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

A study testing Sonic Irrigation Activation, Passive Ultrasonic Irrigation and Laser-Activated Irrigation in people with Chronic Apical Periodontitis, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Apical Periodontitis
What is being tested?
Sonic Irrigation Activation, Passive Ultrasonic Irrigation and Laser-Activated Irrigation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Mar 2024to Dec 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Recep Tayyip Erdoğan University Faculty of Dentistry

    Rize, Rize Province

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effects of Sonic, Ultrasonic, and Laser-Activated Irrigation on Periapical Healing in Teeth With Chronic Apical Periodontitis Using PAI and Fractal Analysis

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.

Being tested
Sonic Irrigation Activation, Passive Ultrasonic Irrigation, Laser-Activated Irrigation
Keywords
Periapical Healing, Irrigation Activation, Sonic Activation, Passive Ultrasonic Irrigation, Laser-Activated Irrigation, Periapical Index, Fractal Analysis, Root Canal Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sonic Irrigation ActivationDevice

    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.

  • Passive Ultrasonic IrrigationDevice

    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.

  • Laser-Activated IrrigationDevice

    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.

Study groups in NCT07850895
Study groupRoleWhat they receive
Sonic ActivationExperimentalRoot 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.
Receives: Device: Sonic Irrigation Activation
Passive Ultrasonic IrrigationExperimentalRoot 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.
Receives: Device: Passive Ultrasonic Irrigation
Laser-Activated IrrigationExperimentalRoot canal treatment was performed using Er:YAG laser-activated irrigation. Laser activation was performed from the coronal pulp chamber for three 20-second cycles.
Receives: Device: Laser-Activated Irrigation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and at least 6 months after root canal treatment

  2. 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.

    Measured: Baseline and at least 6 months after root canal treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2026
  2. Study start6 Mar 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07850895
Sponsor's protocol ID
2026/183
Status last verified
Sep 2026
First submitted
23 Sep 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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