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NCT Number: NCT06418958

Temperature Rise Caused by Short or 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.

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Key information

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida College of Dentistry Dental Clinical Research Unit

Gainesville, Florida, 32610, United States

Location status: Recruiting

Location contact

Dayane Oliveira, DDS, MS, PhD

PRINCIPAL_INVESTIGATOR

Renita Jenkins, CCRC, CDA

CONTACT

[email protected]

352-273-6933

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

red light

Device

Light Curing with Red Light

Blue Light

Device

Light Curing with Blue Light

Primary outcomes

  1. 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.

Secondary outcomes

  1. Post-Operative Sensitivity

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

    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).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

In Vivo Temperature Changes Caused by Exposure to Short- and Long-wavelengths

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 17, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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