Pulp NecrosesNCT06173648
Histopathological Evaluation of the Periodontal Ligament Subjected to Laser Ablation.
A study testing Laser and ICG solution. in people with Pulp Necroses, run by CAO Group, Inc. at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulp Necroses
- What is being tested?
- Laser and ICG solution.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2023to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Requiring at a least one mandibular incisor to be extracted.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histopathological Evaluation of the Periodontal Ligament and Cementum of Extracted Teeth Subjected to Laser Ablation With Indocyanine Green.
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.
Read the 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
- Being tested
- Laser and ICG solution.
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser and ICG solution.Device
Also called Leonardo Diode Laser and LEAP Laser Absorption 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Laser and ICG solution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 28 days after intervention.
Secondary outcomes (1)
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.
Measured: 28 days after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Aug 2023
- Primary completion23 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulp NecrosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAO Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- São Paulo State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173648
- Sponsor's protocol ID
- 70009423.2.0000.5539
- Status last verified
- Feb 2024
- First submitted
- 16 Nov 2023
- Last updated
- 29 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histopathological Evaluation of the Periodontal Ligament and Cementum of Extracted Teeth Subjected to Laser Ablation With Indocyanine Green.
- ClinicalTrials.gov ID
- NCT06173648
- Acronym / sponsor ID
- 70009423.2.0000.5539
- Conditions
- Pulp Necroses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CAO Group, Inc.Industry (pharma, biotech, devices)
- Collaborators
- São Paulo State University
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Posted 29 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| All Study Participants. | Experimental | Device: Laser and ICG solution.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older.
- Requiring at a least one mandibular incisor to be extracted.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser and ICG solution.Also: Leonardo Diode Laser and LEAP Laser Absorption SolutionIntervention 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. | Device | All Study Participants. |
Primary outcome
Cell Count of Inflammatory Infiltrate Per Cross-Sectional Area at 400X Magnification
Time frame: 28 days after intervention.
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.
Gap Distance of Inflammatory Resorption Between Inflamed Tissue and Root Surface
Time frame: 28 days after intervention.
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.
Mean Ligament Thickness of the Periodontal Ligament
Time frame: 28 days after intervention.
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.
1 secondary outcome
Gap Distance of Inflammatory Resorption Between Cementum and Alveolar Bone
Time frame: 28 days after intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser and ICG solution. in people with Pulp Necroses, run by CAO Group, Inc. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell Count of Inflammatory Infiltrate Per Cross-Sectional Area at 400X Magnification (time frame: 28 days after intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.