NCT06173648

Histopathological Evaluation of the Periodontal Ligament Subjected to Laser Ablation.

Histopathological Evaluation of the Periodontal Ligament and Cementum of Extracted Teeth Subjected to Laser Ablation With Indocyanine Green.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: CAO Group, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pulp Necroses

Interventions

Type	Name	Description
DEVICE	Laser and ICG solution.	Intervention consists of addition of a combined laser absorption solution and infrared diode laser. The solution is introduced into the prepared pulp chamber and root canals, allowed to dwell for 1 minute, followed by exposure to the laser energy delivered via a fiber optic introduced into the root canal, and while activating the laser at 2.5 watts of optical output with a pulse duration of 100 msec and a pulse gap of 300 msec, the solution and residual structures in the root and pulp chamber are exposure over the course of 30 seconds, moving and relocating the fiber tip throughout the canals and chamber during that time. The laser is halted and a wait time of 30 seconds is applied. The laser fiber is then reintroduced and another 30 second exposure, repeating the same settings and technique.

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-10-23
• Completion: 2023-10-31
• First posted: 2023-12-18
• Last updated: 2024-02-29
• Results posted: 2024-02-29

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated device study