Trial Outcomes & Findings for Histopathological Evaluation of the Periodontal Ligament Subjected to Laser Ablation. (NCT NCT06173648)

NCT ID: NCT06173648

Last Updated: 2024-02-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

28 days after intervention.

Results posted on

2024-02-29

Participant Flow

There were no issues with participant wash-out after initial acceptance into the study.

Unit of analysis: Mandibular Incisor Teeth

Participant milestones

Participant milestones
Measure
Teeth Exposed to Laser and ICG Solution.
Single study group that requires extraction of mandibular incisors for other reasons. Teeth will be accessed, subject to mechanical file, pulp extirpation, and treated with endodontic solutions. Teeth will then be exposed to the ICG solution followed by laser exposure of the ICG solution in situ. After laser exposure, the pulp chamber and roots will be rinsed and then the tooth mechanically extracted. After extraction, tissue specimens will be prepared of the root portion of the extracted tooth, fixed, stained, and mounted for visual examination under a microscope. Images of the microscopic images will be captured for documentation. The samples will be examined for the histological and morphological condition of the periodontal ligament, cementum, and collagen attached to the external surface of the extracted tooth root. These tissue types were graded based on the extent of damage or destruction observed. Laser and ICG solution.: Intervention consists of addition of laser absorption solution and infrared diode laser. The solution is introduced into pulp chamber and root canals, dwells for 1 minute, followed by exposure to the laser delivered via optical fiber introduced into the root canal, activating the laser at 2.5W optical output, pulse duration of 100msec and pulse gap of 300msec, with laser emissions totaling 30s, moving and relocating the fiber during the exposure. The laser is halted, a 30s wait, then solution and laser is repeated.
Overall Study
STARTED
10 12
Overall Study
COMPLETED
10 12
Overall Study
NOT COMPLETED
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Histopathological Evaluation of the Periodontal Ligament Subjected to Laser Ablation.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Teeth Exposed to Laser and ICG Solution.
n=12 Teeth
Single study group that requires extraction of mandibular incisors for other reasons. Teeth will be accessed, subject to mechanical file, pulp extirpation, and treated with endodontic solutions. Teeth will then be exposed to the ICG solution followed by laser exposure of the ICG solution in situ. After laser exposure, the pulp chamber and roots will be rinsed and then the tooth mechanically extracted. After extraction, tissue specimens will be prepared of the root portion of the extracted tooth, fixed, stained, and mounted for visual examination under a microscope. Images of the microscopic images will be captured for documentation. The samples will be examined for the histological and morphological condition of the periodontal ligament, cementum, and collagen attached to the external surface of the extracted tooth root. These tissue types were graded based on the extent of damage or destruction observed. Laser and ICG solution.: Intervention consists of addition of laser absorption solution and infrared diode laser. The solution is introduced into pulp chamber and root canals, dwells for 1 minute, followed by exposure to the laser delivered via optical fiber introduced into the root canal, activating the laser at 2.5W optical output, pulse duration of 100msec and pulse gap of 300msec, with laser emissions totaling 30s, moving and relocating the fiber during the exposure. The laser is halted, a 30s wait, then solution and laser is repeated.
Age, Categorical
<=18 years
0 Participants
n=10 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=10 Participants
Age, Categorical
>=65 years
0 Participants
n=10 Participants
Sex: Female, Male
Female
6 Participants
n=10 Participants
Sex: Female, Male
Male
4 Participants
n=10 Participants
Region of Enrollment
Brazil
10 participants
n=10 Participants

PRIMARY outcome

Timeframe: 28 days after intervention.

Population: Mandibular incisor teeth

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.

Outcome measures

Outcome measures
Measure
Teeth Exposed to Laser and ICG Solution.
n=12 Teeth
Single study group that requires extraction of mandibular incisors for other reasons. Teeth will be accessed, subject to mechanical file, pulp extirpation, and treated with endodontic solutions. Teeth will then be exposed to the ICG solution followed by laser exposure of the ICG solution in situ. After laser exposure, the pulp chamber and roots will be rinsed and then the tooth mechanically extracted. After extraction, tissue specimens will be prepared of the root portion of the extracted tooth, fixed, stained, and mounted for visual examination under a microscope. Images of the microscopic images will be captured for documentation. The samples will be examined for the histological and morphological condition of the periodontal ligament, cementum, and collagen attached to the external surface of the extracted tooth root. These tissue types were graded based on the extent of damage or destruction observed. Laser and ICG solution.: Intervention consists of addition of laser absorption solution and infrared diode laser. The solution is introduced into pulp chamber and root canals, dwells for 1 minute, followed by exposure to the laser delivered via optical fiber introduced into the root canal, activating the laser at 2.5W optical output, pulse duration of 100msec and pulse gap of 300msec, with laser emissions totaling 30s, moving and relocating the fiber during the exposure. The laser is halted, a 30s wait, then solution and laser is repeated.
Cell Count of Inflammatory Infiltrate Per Cross-Sectional Area at 400X Magnification
Intervention
10.3 Cells / 0.1 mm^2
Standard Deviation 1.79
Cell Count of Inflammatory Infiltrate Per Cross-Sectional Area at 400X Magnification
Control
10.5 Cells / 0.1 mm^2
Standard Deviation 0.2

PRIMARY outcome

Timeframe: 28 days after intervention.

Population: Mandibular incisor teeth

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.

Outcome measures

Outcome measures
Measure
Teeth Exposed to Laser and ICG Solution.
n=12 Teeth
Single study group that requires extraction of mandibular incisors for other reasons. Teeth will be accessed, subject to mechanical file, pulp extirpation, and treated with endodontic solutions. Teeth will then be exposed to the ICG solution followed by laser exposure of the ICG solution in situ. After laser exposure, the pulp chamber and roots will be rinsed and then the tooth mechanically extracted. After extraction, tissue specimens will be prepared of the root portion of the extracted tooth, fixed, stained, and mounted for visual examination under a microscope. Images of the microscopic images will be captured for documentation. The samples will be examined for the histological and morphological condition of the periodontal ligament, cementum, and collagen attached to the external surface of the extracted tooth root. These tissue types were graded based on the extent of damage or destruction observed. Laser and ICG solution.: Intervention consists of addition of laser absorption solution and infrared diode laser. The solution is introduced into pulp chamber and root canals, dwells for 1 minute, followed by exposure to the laser delivered via optical fiber introduced into the root canal, activating the laser at 2.5W optical output, pulse duration of 100msec and pulse gap of 300msec, with laser emissions totaling 30s, moving and relocating the fiber during the exposure. The laser is halted, a 30s wait, then solution and laser is repeated.
Gap Distance of Inflammatory Resorption Between Inflamed Tissue and Root Surface
Intervention
0 micrometer
Standard Deviation 0
Gap Distance of Inflammatory Resorption Between Inflamed Tissue and Root Surface
Control
0 micrometer
Standard Deviation 0

PRIMARY outcome

Timeframe: 28 days after intervention.

Population: Mandibular incisor teeth

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.

Outcome measures

Outcome measures
Measure
Teeth Exposed to Laser and ICG Solution.
n=12 Teeth
Single study group that requires extraction of mandibular incisors for other reasons. Teeth will be accessed, subject to mechanical file, pulp extirpation, and treated with endodontic solutions. Teeth will then be exposed to the ICG solution followed by laser exposure of the ICG solution in situ. After laser exposure, the pulp chamber and roots will be rinsed and then the tooth mechanically extracted. After extraction, tissue specimens will be prepared of the root portion of the extracted tooth, fixed, stained, and mounted for visual examination under a microscope. Images of the microscopic images will be captured for documentation. The samples will be examined for the histological and morphological condition of the periodontal ligament, cementum, and collagen attached to the external surface of the extracted tooth root. These tissue types were graded based on the extent of damage or destruction observed. Laser and ICG solution.: Intervention consists of addition of laser absorption solution and infrared diode laser. The solution is introduced into pulp chamber and root canals, dwells for 1 minute, followed by exposure to the laser delivered via optical fiber introduced into the root canal, activating the laser at 2.5W optical output, pulse duration of 100msec and pulse gap of 300msec, with laser emissions totaling 30s, moving and relocating the fiber during the exposure. The laser is halted, a 30s wait, then solution and laser is repeated.
Mean Ligament Thickness of the Periodontal Ligament
Intervention
173.55 micrometer
Standard Deviation 14.33
Mean Ligament Thickness of the Periodontal Ligament
Control
178.8 micrometer
Standard Deviation 6.66

SECONDARY outcome

Timeframe: 28 days after intervention.

Population: Mandibular incisor teeth

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.

Outcome measures

Outcome measures
Measure
Teeth Exposed to Laser and ICG Solution.
n=12 Teeth
Single study group that requires extraction of mandibular incisors for other reasons. Teeth will be accessed, subject to mechanical file, pulp extirpation, and treated with endodontic solutions. Teeth will then be exposed to the ICG solution followed by laser exposure of the ICG solution in situ. After laser exposure, the pulp chamber and roots will be rinsed and then the tooth mechanically extracted. After extraction, tissue specimens will be prepared of the root portion of the extracted tooth, fixed, stained, and mounted for visual examination under a microscope. Images of the microscopic images will be captured for documentation. The samples will be examined for the histological and morphological condition of the periodontal ligament, cementum, and collagen attached to the external surface of the extracted tooth root. These tissue types were graded based on the extent of damage or destruction observed. Laser and ICG solution.: Intervention consists of addition of laser absorption solution and infrared diode laser. The solution is introduced into pulp chamber and root canals, dwells for 1 minute, followed by exposure to the laser delivered via optical fiber introduced into the root canal, activating the laser at 2.5W optical output, pulse duration of 100msec and pulse gap of 300msec, with laser emissions totaling 30s, moving and relocating the fiber during the exposure. The laser is halted, a 30s wait, then solution and laser is repeated.
Gap Distance of Inflammatory Resorption Between Cementum and Alveolar Bone
Intervention
0 micrometer
Standard Deviation 0
Gap Distance of Inflammatory Resorption Between Cementum and Alveolar Bone
Control
0 micrometer
Standard Deviation 0

Adverse Events

Teeth Exposed to Laser and ICG Solution.

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Teeth Not Exposed to Laser and ICG Solution.

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Renato de Toledo Leonardo

State Univeristy of Paulista Júlio de Mesquita Filho, School of Dentistry at Araraquara

Phone: +55-16-3301-6391

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place