Temperature Rise Caused by Short or Long-wavelengths

University of Florida

Status: Enrolling

Conditions: Post-operative Pain

Treatments: Device: Red Light; Device: Blue Light

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06418958

1K23DE034470-01 (U.S. NIH Grant/Contract)

IRB202300690

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Blue Light

Active Comparator group

Description:

Light-curing procedure performed using blue light emission.

Treatment:

Device: Blue Light

Red Light

Experimental group

Description:

Light-curing procedure performed using red light emission.

Treatment:

Device: Red Light