Temperature Rise Caused by Short or Long-wavelengths

NCT ID: NCT06418958

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-22
• Study Completion Date: 2027-07-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Blue Light

Light-curing procedure performed using blue light emission.

Group Type: ACTIVE_COMPARATOR

Blue Light

Intervention Type: DEVICE

Light Curing with Blue Light

Red Light

Light-curing procedure performed using red light emission.

Group Type: EXPERIMENTAL

Red Light

Intervention Type: DEVICE

Light Curing with Red Light

Interventions

Red Light

Light Curing with Red Light

Intervention Type: DEVICE

Blue Light

Light Curing with Blue Light

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Florida College of Dentistry Dental Clinical Research Unit

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Renita Jenkins, CCRC, CDA

Role: primary

rjenkins@dental.ufl.edu

352-273-6933

Other Identifiers

1K23DE034470-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB202300690

Identifier Type: -

Identifier Source: org_study_id