Temperature Rise Caused by Short or Long-wavelengths

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06418958
• Other study ID #: IRB202300690
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 13, 2025
• Est. completion date: January 13, 2027

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 13, 2027
• Est. primary completion date: January 13, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Device:
• Red Light
Light Curing with Red Light
• Blue Light
Light Curing with Blue Light

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature Change	Temperature changes in degrees Celsius will be live-recorded by means of temperature probes for surface temperature acquisition.	During restorative procedure.
Secondary	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).	One week (±2 days) after intervention.