Clinical trial NCT06173648: Histopathological Evaluation of the Periodontal Ligament Subjected to Laser Ablation.
Official title: Histopathological Evaluation of the Periodontal Ligament and Cementum of Extracted Teeth Subjected to Laser Ablation With Indocyanine Green.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulp Necroses
Lead sponsor: CAO Group, Inc.
Sponsor class: INDUSTRY
Collaborators: name: São Paulo State University
First posted: 2023-12-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single study group requiring extraction of mandibular incisors for other reasons. Controls selected from among the extraction candidates were not subject to exposure to the laser and ICG solution, but to all other aspects of the pulpectomy procedure. Remaining teeth had the laser and ICG exposure added to the treatment regimen. Treated and control specimens then extracted, prepared, stained, and examined for histological morphological condition of the periodontal ligament, cementum, and collagen attached to the external surface of the extracted tooth root.
Primary purpose: TREATMENT

Brief summary: Laser Ablation therapy (LA) using an 810nm diode laser and Indocyanine Green (ICG) solution, which efficiently absorbs laser energy and increases the effectiveness of tissue removal. Intracanal heating can potentially cause damage to structures outside the tooth root. The study was to observe possible changes in the periodontal ligament and cementum resulting outside the root using this treatment. Histological and morphological examination of extracted cementum, ligament, and collagen post-exposure showed no difference in these structures vs. non-treated controls.

Detailed description: Laser Ablation therapy (LA) using 810nm diode laser and Indocyanine Green (ICG) solution which efficiently absorbs laser energy and the increased temperature results in an instantaneous flame that chars tissue and microbes. Intracanal heating can potentially cause damage to cementum structure and periodontal tissues. The objective of this study is to observe possible changes in the periodontal ligament and cementum resulting from the use of LA with ICG as an adjuvant therapy to endodontic treatment. Ten patients with lower incisors requiring extraction will be selected. Before extraction, chemical-mechanical root canal preparation will be carried out with a single file reciprocating system (35/04) and 2.5% sodium hypochlorite solution. Then, the canals will be dried and filled with 0.05% ICG, which will remain in place for 1 minute (pre-irradiation time). For the test group, a #20 laser fiber will be inserted into the root canal to the working length. The 810 nm wavelength infrared diode laser is activated with a power of 2.5W, an interval of 300 ms, and a duration of 100 ms. After activation commences, circular movements are made for a period of 30 seconds together with the fiber removal movement. After the first activation, there is a 30-second pause and a new 30-second activation cycle will then be performed in the same way as the previous one. After treatment, the tooth element will be extracted and the apical third of the root with the periodontal ligament is processed for histological analysis using hematoxylin-eosin and picrosirius red staining to evaluate the morphological structures. Two teeth extracted without treatment will be used as controls.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older.
* Requiring at a least one mandibular incisor to be extracted.

Exclusion Criteria:

* Evidence of periodontal disease anywhere in the mouth beyond the apical third of any tooth.
* Mandibular canines that do not require extraction.
* Presence of other dental or oral conditions of any type that require immediate intervention.

Primary outcomes:
measure: Cell Count of Inflammatory Infiltrate Per Cross-Sectional Area at 400X Magnification
timeFrame: 28 days after intervention.
measure: Gap Distance of Inflammatory Resorption Between Inflamed Tissue and Root Surface
timeFrame: 28 days after intervention.
measure: Mean Ligament Thickness of the Periodontal Ligament
timeFrame: 28 days after intervention.
Secondary outcomes:
measure: Gap Distance of Inflammatory Resorption Between Cementum and Alveolar Bone
timeFrame: 28 days after intervention.
Other outcomes:
Locations:
city: Maringá
country: Brazil
facility: Unicesumar Clinic
state: Parana
Study officials:
References: