Temperature Rise Caused by Short or Long-wavelengths

University of Florida50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Post-operative Pain

Interventions

Red LightDEVICE

Light Curing with Red Light

Blue LightDEVICE

Light Curing with Blue Light

Eligibility

Sex: ALLMin age: 21 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Florida College of Dentistry Dental Clinical Research Unit

Gainesville, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

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

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.

Data from ClinicalTrials.gov

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