Tooth PainNCT03946904
Clinical Study of Laser Analgesia in Cavity Preparations Using the Er,Cr:YSGG Laser
A study testing Er,Cr:YSGG Laser in people with Tooth Pain, run by Chen Laser Institute at 1 site in United States.
Trial summary
Not much has been done in research to explain the clinical benefit of laser cavity preparation without the use of injection anesthetic. The Author of this study sought to show the science behind the "no shot, no pain" in restorative dentistry using an Er,Cr:YSGG laser Patients with two similar size lesions of class I… Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Pain
- What is being tested?
- Er,Cr:YSGG Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2018to 15 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- You are an adult 19-65 years of age who had at least two cavity preparations of the same type, with the same approximate size lesion.
- No language barriers
- Not Pregnant
- Immune system is not compromised (No bronchitis, no sinus infection, no ear infection, or any other infection of any type ect…)
- No Heart Disease
- No high blood pressure
- No teeth amalgam restorations were in close proximity to the lesion.
- Requiring at least two cavity preparations of the same type, with the same approximate size of lesion (minimum 1mm diameter x 1mm depth).
Who cannot join
- Children
- Pregnant women
- Immune compromised patients
- Patients with heart disease
- High blood pressure
- Cardiac arrhythmia
Show all 9Show fewer
- Patients whose teeth amalgam restorations were in close proximity to the lesion
- Decay that has reached the pulp where potential for root canal therapy
- Patients of different language difficulty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of Laser Analgesia in Cavity Preparations
Not much has been done in research to explain the clinical benefit of laser cavity preparation without the use of injection anesthetic. The Author of this study sought to show the science behind the "no shot, no pain" in restorative dentistry using an Er,Cr:YSGG laser Patients with two similar size lesions of class I or class V cavities selected as subjects. In the same appointment, both cavities are prepared by the Er,Cr:YSGG. One lesion was prepared with one high power laser setting to ablate the enamel, dentin, and caries. The other lesion was prepared with a low power setting to start and is aimed at applying low level laser therapy (LLLT) before using the high power setting to ablate enamel, dentin, and caries. A visual analog scale (VAS) was used for the patient to analyze how comfortable each laser technique was. An Analysis of Variance (ANOVA) was used.
Read the detailed description
The principal objective of this study is to prove the phenomenon of laser analgesia. Traditionally before a cavity preparation is performed, the doctor will use local anesthetic (Needle Injection) before using rotary instrument to do a cavity preparation. The study involves using the Er,Cr=YSGG Laser to perform cavity preparation without giving any injection anesthesia. VAS (Visual Analog Scale) will be used to have patients rate the laser cavity preparation procedure to show there is laser analgesia. On each patient subject that has two similar size cavities of the same classification, either Class I or Class V, on similar teeth. Two different laser protocols will be used. One includes Low Level Laser Therapy (LLLT) to condition the pulp producing analgesia before using higher power to perform the cavity prep. The other protocol will skip the LLLT setting and prepare the cavity with the higher power to perform the cavity prep. The design of the study is to find out if there is laser analgesia and if LLLT makes a difference in providing better analgesia. The VAS forms from each procedure will be used to show there is laser analgesia and potentially cavity preparations can be performed by using the laser without the need to give injection anesthesia first. 48 patients will be included in this study.
Treatment. Preconditioning and cavity preparation are done using the Er:Cr:YSGG laser, Waterlase MD (mfg: Biolase Technology Inc, Irvine CA), and the gold hand piece with an MG6 fiber tip, trunk fiber, contra-angle hand piece. Preconditioning. Preconditioning is preformed using laser desensitization. One tooth will be randomly selected, and preconditioning will be performed using LLLT on the tooth with minimal tooth ablation. The LLLT settings that will be used for preconditioning are 0.25 Watts, 50 Hz, 0% water, 0% air, H mode. Following this a fiber-optic tip will be aimed perpendicular to the surface of the cervical portion of the tooth, ensuring that a 2mm distance will be maintained between the end of the fiber optic tip and the surface. The fiber-tip will be used to generate a 2mm line. The cavity on the second tooth will be prepared for without laser preconditioning. Lesion Preparation - small preparations. Small preparations are to be performed as follows. The Waterlase MD is set to 4.5W, 15 Hz, 65% air, and 60% water and the cavity is prepared according to the preferred technique. If patients indicate sensitivity, the procedure will be halted, patients fill out the VAS form and anesthetic will be offered. For patients who refuse anesthetic, the procedure will be continued at the same settings. Lesion Preparation - small to medium preparations. Small to medium preparations will be performed as follows. The Waterlase MD will be set to 2W, 15 Hz, 65% air, and 60% water and the cavity will be prepared according to the preferred technique. If patients indicate sensitivity, the procedure will be halted, patients fill out the VAS form and anesthetic will be offered. For patients who refuse anesthetic, the procedure will be continued at the same settings.
Restoration. Overall VAS Score. Up to 3 intra-operative VAS measurements are recorded. If a patient feels even the slightest amount of pain during the procedure, they will be instructed to raise their hand and the treatment will be paused. The patient is then asked to fill in the VAS form before the procedure will be continued. After conclusion of the cavity preparation, patients will be asked to mark one last VAS rating indicating the overall pain of the procedure. Patients that do not raise their hand throughout the entirety of the procedure will be given an overall VAS rating of zero. Data for each patient will be recorded and analyzed in this way.
The VAS scale will be presented to the patients using a standard explanation (zero, indicating no pain at all, to 100, representing the 'worst pain patient had ever felt'). Patients will be asked to place a vertical line on the VAS scale to indicate his/her discomfort status. They are encouraged to stop the treatment if they encounter any pain. The number of hand raises, as defined by the protocol, will be recorded and analyzed (small and medium/large preparations are analyzed separately), represent the number of times during the procedure the patient felt sufficient discomfort to stop the procedure. VAS data will be assessed by the following assumptions: The 'lower' the average score, the 'better' the mode of treatment. Once the patient marks their vertical line on the scale, a precise measurement, in millimeters, was taken from the "zero" line of the VAS scale to where the patient marked their line.
- Conditions
- Tooth Pain
- Being tested
- Er,Cr:YSGG Laser
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er,Cr:YSGG LaserDevice
Also called Iplus laser
Patients with towo similar size lesions of either Class I or class v cavities selected as subjects. in the same appointment, both cavities are prepared by the Er'Cr:YSGG. one lesion was prepared with high power laser setting first to ablate the enamel, dentin, and caries. the other lesion was prepared with low power setting to start and is aimed at applying low level laser therapy (LLLT) first before using high power.
| Study group | Role | What they receive |
|---|---|---|
| preconditioning | Experimental | Patients with towo similar size lesions of either Class I or class v cavities selected as subjects. in the same appointment, both cavities are prepared by the Er'Cr:YSGG. The lesion in this case was prepared with low power setting to start and is aimed at applying low level laser therapy (LLLT) first before using high power. Receives: Device: Er,Cr:YSGG Laser |
| no preconditioning | Experimental | Patients with towo similar size lesions of either Class I or class v cavities selected as subjects. in the same appointment, both cavities are prepared by the Er'Cr:YSGG.the lesion in this case was prepared with high power laser setting first to ablate the enamel, dentin, and caries. Receives: Device: Er,Cr:YSGG Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Study of Laser Analgesia in Cavity Preparations using the Er,Cr:YSGG Laser
Preconditioning the cavity with LLLT will result in effective analgesia and the cavity preparation will be virtually painless. Overall VAS Score: Up to 3 intra-operative VAS measurements will be recorded. If a patient felt any pain at all during the procedure, they were instructed to raise their hand and the treatment would be paused. The patient was then asked to fill in the VAS form and then the procedure continued. After the conclusion of the cavity preparation, the patients were asked to fill in one last VAS form rating the overall pain of the procedure. Patients that did not raise their hand throughout the entirety of the procedure were given an overall VAS rating of zero. Data for each patient will be recorded and analysed in this way.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start18 Dec 2018
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chen Laser Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William H Chen, doctor, Principal investigator, Chen Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946904
- Sponsor's protocol ID
- 18-CHEN-101
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 13 May 2019
- Results posted
- No
- 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 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Laser Analgesia in Cavity Preparations
- ClinicalTrials.gov ID
- NCT03946904
- Acronym / sponsor ID
- 18-CHEN-101
- Conditions
- Tooth Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chen Laser InstituteUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Not much has been done in research to explain the clinical benefit of laser cavity preparation without the use of injection anesthetic. The Author of this study sought to show the science behind the "no shot, no pain" in restorative dentistry using an Er,Cr:YSGG laser Patients with two similar size lesions of class I or class V cavities selected as subjects. In the same appointment, both cavities are prepared by the Er,Cr:YSGG. One lesion was prepared with one high power laser setting to ablate the enamel, dentin, and caries. The other lesion was prepared with a low power setting to start and is aimed at applying low level laser therapy (LLLT) before using the high power setting to ablate enamel, dentin, and caries. A visual analog scale (VAS) was used for the patient to analyze how comfortable each laser technique was. An Analysis of Variance (ANOVA) was used.
Detailed description
The principal objective of this study is to prove the phenomenon of laser analgesia. Traditionally before a cavity preparation is performed, the doctor will use local anesthetic (Needle Injection) before using rotary instrument to do a cavity preparation. The study involves using the Er,Cr=YSGG Laser to perform cavity preparation without giving any injection anesthesia. VAS (Visual Analog Scale) will be used to have patients rate the laser cavity preparation procedure to show there is laser analgesia. On each patient subject that has two similar size cavities of the same classification, either Class I or Class V, on similar teeth. Two different laser protocols will be used. One includes Low Level Laser Therapy (LLLT) to condition the pulp producing analgesia before using higher power to perform the cavity prep. The other protocol will skip the LLLT setting and prepare the cavity with the higher power to perform the cavity prep. The design of the study is to find out if there is laser analgesia and if LLLT makes a difference in providing better analgesia. The VAS forms from each procedure will be used to show there is laser analgesia and potentially cavity preparations can be performed by using the laser without the need to give injection anesthesia first. 48 patients will be included in this study.
Treatment. Preconditioning and cavity preparation are done using the Er:Cr:YSGG laser, Waterlase MD (mfg: Biolase Technology Inc, Irvine CA), and the gold hand piece with an MG6 fiber tip, trunk fiber, contra-angle hand piece. Preconditioning. Preconditioning is preformed using laser desensitization. One tooth will be randomly selected, and preconditioning will be performed using LLLT on the tooth with minimal tooth ablation. The LLLT settings that will be used for preconditioning are 0.25 Watts, 50 Hz, 0% water, 0% air, H mode. Following this a fiber-optic tip will be aimed perpendicular to the surface of the cervical portion of the tooth, ensuring that a 2mm distance will be maintained between the end of the fiber optic tip and the surface. The fiber-tip will be used to generate a 2mm line. The cavity on the second tooth will be prepared for without laser preconditioning. Lesion Preparation - small preparations. Small preparations are to be performed as follows. The Waterlase MD is set to 4.5W, 15 Hz, 65% air, and 60% water and the cavity is prepared according to the preferred technique. If patients indicate sensitivity, the procedure will be halted, patients fill out the VAS form and anesthetic will be offered. For patients who refuse anesthetic, the procedure will be continued at the same settings. Lesion Preparation - small to medium preparations. Small to medium preparations will be performed as follows. The Waterlase MD will be set to 2W, 15 Hz, 65% air, and 60% water and the cavity will be prepared according to the preferred technique. If patients indicate sensitivity, the procedure will be halted, patients fill out the VAS form and anesthetic will be offered. For patients who refuse anesthetic, the procedure will be continued at the same settings.
Restoration. Overall VAS Score. Up to 3 intra-operative VAS measurements are recorded. If a patient feels even the slightest amount of pain during the procedure, they will be instructed to raise their hand and the treatment will be paused. The patient is then asked to fill in the VAS form before the procedure will be continued. After conclusion of the cavity preparation, patients will be asked to mark one last VAS rating indicating the overall pain of the procedure. Patients that do not raise their hand throughout the entirety of the procedure will be given an overall VAS rating of zero. Data for each patient will be recorded and analyzed in this way.
The VAS scale will be presented to the patients using a standard explanation (zero, indicating no pain at all, to 100, representing the 'worst pain patient had ever felt'). Patients will be asked to place a vertical line on the VAS scale to indicate his/her discomfort status. They are encouraged to stop the treatment if they encounter any pain. The number of hand raises, as defined by the protocol, will be recorded and analyzed (small and medium/large preparations are analyzed separately), represent the number of times during the procedure the patient felt sufficient discomfort to stop the procedure. VAS data will be assessed by the following assumptions: The 'lower' the average score, the 'better' the mode of treatment. Once the patient marks their vertical line on the scale, a precise measurement, in millimeters, was taken from the "zero" line of the VAS scale to where the patient marked their line.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preconditioning | Experimental | Device: Er,Cr:YSGG LaserPatients with towo similar size lesions of either Class I or class v cavities selected as subjects. in the same appointment, both cavities are prepared by the Er'Cr:YSGG. The lesion in this case was prepared with low power setting to start and is aimed at applying low level laser therapy (LLLT) first before using high power. |
| no preconditioning | Experimental | Device: Er,Cr:YSGG LaserPatients with towo similar size lesions of either Class I or class v cavities selected as subjects. in the same appointment, both cavities are prepared by the Er'Cr:YSGG.the lesion in this case was prepared with high power laser setting first to ablate the enamel, dentin, and caries. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- You are an adult 19-65 years of age who had at least two cavity preparations of the same type, with the same approximate size lesion.
- No language barriers
- Not Pregnant
- Immune system is not compromised (No bronchitis, no sinus infection, no ear infection, or any other infection of any type ect…)
- No Heart Disease
Key exclusion criteria (9 listed)
- Children
- Pregnant women
- Immune compromised patients
- Patients with heart disease
- High blood pressure
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 |
|---|---|---|
| Er,Cr:YSGG LaserAlso: Iplus laserPatients with towo similar size lesions of either Class I or class v cavities selected as subjects. in the same appointment, both cavities are prepared by the Er'Cr:YSGG. one lesion was prepared with high power laser setting first to ablate the enamel, dentin, and caries. the other lesion was prepared with low power setting to start and is aimed at applying low level laser therapy (LLLT) first before using high power. | Device | no preconditioning, preconditioning |
Primary outcome
Clinical Study of Laser Analgesia in Cavity Preparations using the Er,Cr:YSGG Laser
Time frame: 1 year
Preconditioning the cavity with LLLT will result in effective analgesia and the cavity preparation will be virtually painless. Overall VAS Score: Up to 3 intra-operative VAS measurements will be recorded. If a patient felt any pain at all during the procedure, they were instructed to raise their hand and the treatment would be paused. The patient was then asked to fill in the VAS form and then the procedure continued. After the conclusion of the cavity preparation, the patients were asked to fill in one last VAS form rating the overall pain of the procedure. Patients that did not raise their hand throughout the entirety of the procedure were given an overall VAS rating of zero. Data for each patient will be recorded and analysed in this way.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- 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.
William H Chen, doctor principal investigator
Chen Laser Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Er,Cr:YSGG Laser in people with Tooth Pain, run by Chen Laser Institute at 1 site in United States.
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 8 inclusion and 9 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 13 May 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Study of Laser Analgesia in Cavity Preparations using the Er,Cr:YSGG Laser (time frame: 1 year). 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 13 May 2019.