Clinical trial NCT06418958: Temperature Rise Caused by Short or Long-wavelengths
Official title: In Vivo Temperature Changes Caused by Exposure to Short- and Long-wavelengths
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-operative Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2024-05-17
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Temperature Change
timeFrame: During restorative procedure.
Secondary outcomes:
measure: Post-Operative Sensitivity
timeFrame: One week (±2 days) after intervention.
Other outcomes:
Locations:
Study officials:
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