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NCT06418958 | NOT YET RECRUITING | Post-operative Pain


Temperature Rise Caused by Short or Long-wavelengths
Sponsor:

University of Florida

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.

Condition or disease

Post-operative Pain

Intervention/treatment

Red Light

Blue Light

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : In Vivo Temperature Changes Caused by Exposure to Short- and Long-wavelengths
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2027-06-25
Estimated Study Completion Date : 2027-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 35 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.

Temperature Rise Caused by Short or Long-wavelengths

Location Details

NCT06418958


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