Post-operative PainNCT06418958
Temperature Rise Caused by Short or Long-wavelengths
A study testing Red Light and Blue Light in people with Post-operative Pain, run by University of Florida at 1 site in United States.
Trial summary
Red light has been shown to be less harmful than blue light in vitro and in vivo. Although red light has been already introduced in the market and is currently being used in patients for several reasons, no data exist on the use of red light applied to restorative procedures. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Red Light and Blue Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I classification
- Fully erupted pre-molar(s);
- Absence of caries;
- Absence of restoration.
Who cannot join
- Radiographic constriction of the pulp chamber;
- Absence of apical closure;
- Formation of pulp stones or diffuse calcification at the pulp chamber;
- Presence of active carious lesions;
- Diagnosed reversible or irreversible pulpitis;
- Existing periapical lesion;
- Existing or planned root canal treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida College of Dentistry Dental Clinical Research Unit
Gainesville, Florida, 32610
Renita Jenkins, CCRC, CDA, 352-273-6933, rjenkins@dental.ufl.edu
Dayane Oliveira, DDS, MS, PhD
About this study
Official title: In Vivo Temperature Changes Caused by Exposure to Short- and Long-wavelengths
Red light has been shown to be less harmful than blue light in vitro and in vivo. Although red light has been already introduced in the market and is currently being used in patients for several reasons, no data exist on the use of red light applied to restorative procedures. This study aims to specifically measure the in vivo temperature rise in simulated restorative procedures using blue light (standard) and red light and its post-operative sensitivity rates.
Read the detailed description
Light-cured materials revolutionized dentistry as they allowed to control the setting of the materials in a timely manner simply upon light exposure. Although blue light has been routinely used to cure dental restorative materials for over 50 years, there are still potential risks to dental patients. These risks include gingiva burn or recession and pulp inflammation that can lead to necrosis in more severe situations due to the heat generated by this short wavelength (blue light). In addition, blue light has direct deleterious effects on cells, including irreversible imbalance in reactive oxygen species (ROS), damage to the mitochondrial DNA, and promoting collagen degradation. On the other hand, long wavelengths (such as red light) are known to have opposite effects, reducing inflammation and increasing cell proliferation. Although red light has been already introduced in the market and is currently being used in patients for several reasons, no in vivo data exist on the use of red-light applied to restorative procedures. Thus, this study aims to specifically measure the in vivo temperature rise in the tooth and gingival tissues surrounding restorative procedures using blue light (standard of care) and red light (investigational device) and evaluate/compare its post-operative sensitivity rates. The research hypothesis is that red light will generate less heat and less post-operative sensitivity than blue light (standard of care) while being used in dental restorative procedures.
- Conditions
- Post-operative Pain
- Being tested
- Red Light, Blue Light
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red LightDevice
Light Curing with Red Light
Blue LightDevice
Light Curing with Blue Light
| Study group | Role | What they receive |
|---|---|---|
| Blue Light | Active comparator | Light-curing procedure performed using blue light emission. Receives: Device: Blue Light |
| Red Light | Experimental | Light-curing procedure performed using red light emission. Receives: Device: Red Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature Change
Temperature changes in degrees Celsius will be live-recorded by means of temperature probes for surface temperature acquisition.
Measured: During restorative procedure.
Secondary outcomes (1)
Post-Operative Sensitivity
All patients will be called after the restoration(s) were placed to follow-up on any possible post-operative sensitivity or other questions or concerns. Post-operative sensitivity will be recorded as present or absent. If present, the post-operative sensitivity will be classified as mild, moderate, or severe according to the visual analog scale (VAS).
Measured: One week (±2 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 posted17 May 2024
- Study start22 Sep 2025
- Primary completion25 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418958
- Sponsor's protocol ID
- IRB202300690
- Other IDs
- 1K23DE034470-01
- Status last verified
- Sep 2025
- First submitted
- 2 May 2024
- Last updated
- 19 Nov 2025
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Temperature Changes Caused by Exposure to Short- and Long-wavelengths
- ClinicalTrials.gov ID
- NCT06418958
- Acronym / sponsor ID
- IRB202300690
- Conditions
- Post-operative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 25 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 17 May 2024 (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.
Red light has been shown to be less harmful than blue light in vitro and in vivo. Although red light has been already introduced in the market and is currently being used in patients for several reasons, no data exist on the use of red light applied to restorative procedures. This study aims to specifically measure the in vivo temperature rise in simulated restorative procedures using blue light (standard) and red light and its post-operative sensitivity rates.
Detailed description
Light-cured materials revolutionized dentistry as they allowed to control the setting of the materials in a timely manner simply upon light exposure. Although blue light has been routinely used to cure dental restorative materials for over 50 years, there are still potential risks to dental patients. These risks include gingiva burn or recession and pulp inflammation that can lead to necrosis in more severe situations due to the heat generated by this short wavelength (blue light). In addition, blue light has direct deleterious effects on cells, including irreversible imbalance in reactive oxygen species (ROS), damage to the mitochondrial DNA, and promoting collagen degradation. On the other hand, long wavelengths (such as red light) are known to have opposite effects, reducing inflammation and increasing cell proliferation. Although red light has been already introduced in the market and is currently being used in patients for several reasons, no in vivo data exist on the use of red-light applied to restorative procedures. Thus, this study aims to specifically measure the in vivo temperature rise in the tooth and gingival tissues surrounding restorative procedures using blue light (standard of care) and red light (investigational device) and evaluate/compare its post-operative sensitivity rates. The research hypothesis is that red light will generate less heat and less post-operative sensitivity than blue light (standard of care) while being used in dental restorative procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blue Light | Active comparator | Device: Blue LightLight-curing procedure performed using blue light emission. |
| Red Light | Experimental | Device: Red LightLight-curing procedure performed using red light emission. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA I classification
- Fully erupted pre-molar(s);
- Absence of caries;
- Absence of restoration.
Key exclusion criteria (7 listed)
- Radiographic constriction of the pulp chamber;
- Absence of apical closure;
- Formation of pulp stones or diffuse calcification at the pulp chamber;
- Presence of active carious lesions;
- Diagnosed reversible or irreversible pulpitis;
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 |
|---|---|---|
| Red LightLight Curing with Red Light | Device | Red Light |
| Blue LightLight Curing with Blue Light | Device | Blue Light |
Primary outcome
Temperature Change
Time frame: During restorative procedure.
Temperature changes in degrees Celsius will be live-recorded by means of temperature probes for surface temperature acquisition.
1 secondary outcome
Post-Operative Sensitivity
Time frame: One week (±2 days) after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- 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.
University of Florida College of Dentistry Dental Clinical Research Unit
Gainesville, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Light and Blue Light in people with Post-operative Pain, run by University of Florida 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature Change (time frame: During restorative procedure.). 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 19 Nov 2025.