Histopathological Evaluation of the Periodontal Ligament Subjected to Laser Ablation.

Pulp Necroses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06173648
• Other study ID #: 70009423.2.0000.5539
• Status: Completed
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: CAO Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 31, 2023
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Pulp Necroses

Intervention

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.

Locations

Country	Name	City	State
Brazil	Unicesumar Clinic	Maringá	Parana

Sponsors (2)

Lead Sponsor	Collaborator
CAO Group, Inc.	Sao Paulo State University, School of Dentistry at Aracatuba, Sao Paulo, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cell Count of Inflammatory Infiltrate Per Cross-Sectional Area at 400X Magnification	Count the number of inflammatory cells within a cross-sectional area viewed under 400X magnification, comparing the difference in the quantity of inflamed cells reacting to injury to the tissues resulting from the investigational treatment, as compared a count of inflamed cells reacting to the control treatment.	28 days after intervention.
Primary	Gap Distance of Inflammatory Resorption Between Inflamed Tissue and Root Surface	Measurement of the gap between the edge of the inflamed tissue and the root surface, measured in microns using computer software to measure the gap of magnified tissue samples, comparing samples from teeth treated with the intervention compared to teeth receiving the control treatment.	28 days after intervention.
Primary	Mean Ligament Thickness of the Periodontal Ligament	Measurement of the thickness of the periodontal ligament, measured in microns using computer software to measure the thickness of periodontal ligament within the magnified tissue samples, comparing samples from teeth treated with the intervention compared to teeth receiving the control treatment.	28 days after intervention.
Secondary	Gap Distance of Inflammatory Resorption Between Cementum and Alveolar Bone	Measurement of the gap between the edge of the tooth cementum and the adjacent alveolar bone, measured in microns using computer software to measure the gap of magnified tissue samples, comparing samples from teeth treated with the intervention compared to teeth receiving the control treatment.	28 days after intervention.