Clinical trial NCT06204887: Effect of Irrigation-Activation Techniques on Healing in Large Periapical Lesions
Official title: Evaluation of Different Irrigation-Activation Techniques on Healing Outcome of Large Periapical Lesions: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Irrigation Activation on Periapical Healing
Keywords: Irrigation activation
periapical healing
Lead sponsor: Recep Tayyip Erdogan University
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to highlight the healing rates of large periapical lesions after different irrigation activation treatments as manual dynamic activation (MDA), passive ultrasonic irrigation (PUI), shock wave-enhanced emission photoacoustic streaming (SWEEPS) using CBCT scans based on volumetric change analysis during 1-year follow-up.

Detailed description: The aim of this study was to highlight the healing rates of large periapical lesions after different irrigation activation treatments as manual dynamic activation (MDA), passive ultrasonic irrigation (PUI), shock wave-enhanced emission photoacoustic streaming (SWEEPS) using CBCT scans based on volumetric change analysis during 1-year follow-up.

A total of 56 systemically healthy male/female patients with mandibular single-rooted teeth with a periapical index score (PAI) of 3 or higher were included in the study. Pretreatment lesion volumes were determined by CBCT. Patients were randomly divided into 3 study groups (PUI, SWEEPS, MDA) and control group (n=14). For the follow-up routine, 2D radiographs were taken at months 3, 6, and 9, as well as clinical examinations. At the end of 12 months, 3D evaluation of lesion volumes was performed using ITK SNAP. Pretreatment and follow-up values were statistically analyzed with the Wilcoxon test.

Eligibility criteria: Inclusion Criteria:

* Patients having single root mandibular teeth
* Patients the diagnosis of chronic apical periodontitis,
* Periapical index score of 3 and above,
* Patients having good oral hygiene

Exclusion Criteria:

* Patients with systemic diseases (diabetes, hypertension, chronic liver disease, coagulation disorders),
* Patients with bone metabolism disease and/or
* Patients using drugs that affect bone metabolism (such as steroids, bisphosphonates)
* Patients with a history of radiotherapy
* Pregnant patients
* Teeth with mobility of 2 or more, periodontal pocket depth of 5 mm or more, generalized chronic periodontitis, internal and external resorption, and/or vertical and horizontal root fractures

Primary outcomes:
measure: Percentage Change in Lesion Volume at 12-months Follow-up
timeFrame: One year from the beginning of the study
measure: Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up
timeFrame: One year from the beginning of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University
Study officials:
affiliation: Recep Tayyip Erdogan University
name: Ahter Şanal Çıkman
role: PRINCIPAL_INVESTIGATOR
References: