N/A
N=10
Histopathological Evaluation of the Periodontal Ligament Subjected to Laser Ablation.
Pulp Necroses
Bottom Line
View on ClinicalTrials.gov: NCT06173648 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Cell Count of Inflammatory Infiltrate Per Cross-Sectional Area at 400X Magnification — 10.3; 10.5 Cells / 0.1 mm^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laser and ICG solution. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CAO Group, Inc.
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cell Count of Inflammatory Infiltrate Per Cross-Sectional Area at 400X Magnification |
10.3; 10.5 | — |
| PRIMARY Gap Distance of Inflammatory Resorption Between Inflamed Tissue and Root Surface |
0; 0 | — |
| PRIMARY Mean Ligament Thickness of the Periodontal Ligament |
173.55; 178.8 | — |
| SECONDARY Gap Distance of Inflammatory Resorption Between Cementum and Alveolar Bone |
0; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT06173648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.