Histopathological Evaluation of the Periodontal Ligament Subjected to Laser Ablation.

NCT06173648 | Completed Results FDA Device

• 1 other identifier: 70009423.2.0000.5539
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulp Necroses

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (1)

• Gap Distance of Inflammatory Resorption Between Cementum and Alveolar Bone

  28 days after intervention.

Study Arms (1)

All Study Participants.

EXPERIMENTAL

Single study group that requires extraction of mandibular incisors for other reasons. Teeth are accessed, subject to filing, pulp extirpation, and treated with endodontic solutions. Some teeth of the participants are then subject to study intervention consisting of an ICG solution into the root followed by laser exposure of the solution in situ. After laser exposure, the pulp chamber and roots are rinsed then mechanically extracted. Other teeth of some participants will not be subject to the ICG and laser intervention, but will proceed to the final rinse and extraction. After extraction, specimens are fixed, stained, and mounted for visual examination under a microscope. Images of tissue are captured for documentation. Samples are examined for histological and morphological condition of the periodontal ligament, cementum, and collagen attached to the external surface of the extracted tooth root.

Device: Laser and ICG solution.

Interventions

Laser and ICG solution. DEVICE

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.

Also known as: Leonardo Diode Laser and LEAP Laser Absorption Solution

All Study Participants.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CAO Group, Inc.: lead
• São Paulo State University: collaborator

Study Sites (1)

Unicesumar Clinic

Maringá, Paraná, 87050-900, Brazil

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Lasers

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Dr. Renato de Toledo Leonardo
• Organization: State Univeristy of Paulista Júlio de Mesquita Filho, School of Dentistry at Araraquara

rleonard@foar.unesp.br

+55-16-3301-6391

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinding occurred when analyzing the histological and morphological results. Blinded assessor provided a rating of the samples on an individual basis, not knowing if the sample was from a treated or control tooth.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 18, 2023
• Study Start: August 1, 2023
• Primary Completion: October 23, 2023
• Study Completion: October 31, 2023
• Last Updated: February 29, 2024
• Results First Posted: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)