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RecruitingNCT06418958Updated Nov 19, 2025

Temperature Rise Caused by Short or Long-wavelengths

An interventional study of Red Light and Blue Light in Post-operative Pain, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 21 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-19.

Sponsored by University of Florida · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
21 Years to 35 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Post-operative Pain

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 50 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • ASA I classification
  • Fully erupted pre-molar(s);
  • Absence of caries;
  • Absence of restoration.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Blue Light

    Light-curing procedure performed using blue light emission.

    Device: Blue Light

  • Experimental
    Red Light

    Light-curing procedure performed using red light emission.

    Device: Red Light

Interventions

  • DeviceRed Light

    Light Curing with Red Light

  • DeviceBlue Light

    Light Curing with Blue Light

06

What researchers measure

Primary outcomes

  1. Temperature Change

    Temperature changes in degrees Celsius will be live-recorded by means of temperature probes for surface temperature acquisition.

    Time frame: 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).

    Time frame: One week (±2 days) after intervention.

07

Study locations

1 of 1 sites recruiting
  • University of Florida College of Dentistry Dental Clinical Research Unit
    Gainesville, Florida 32610, United States
    • Renita Jenkins, CCRC, CDA · Contact · rjenkins@dental.ufl.edu · 352-273-6933
    • Dayane Oliveira, DDS, MS, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06418958
Lead sponsor
University of Florida
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Responsible party
Sponsor
First posted
May 17, 2024
Start date
Sep 22, 2025
Primary completion
Jun 25, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Nov 19, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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