## Protocol Section
### Identification Module
**NCT ID:** NCT06418958

**Brief Title:** Temperature Rise Caused by Short or Long-wavelengths

**Official Title:** In Vivo Temperature Changes Caused by Exposure to Short- and Long-wavelengths

#### Organization Study ID Info
**ID:** IRB202300690
#### Organization
**Class:** OTHER
**Full Name:** University of Florida
### Status Module
#### Completion Date
**Date:** 2027-01-13

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-01-13

**Type:** ESTIMATED

#### Start Date
**Date:** 2025-01-13

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-02
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Florida

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is Unapproved Device:** True

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Post-operative Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: Light-curing

**Label:** Blue Light

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Device: Light-curing

**Label:** Red Light

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Blue Light

- Red Light

**Description:** Light Curing

**Name:** Light-curing

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Temperature changes in degrees Celsius will be live-recorded by means of temperature probes for surface temperature acquisition.

**Measure:** Temperature Change

**Time Frame:** During restorative procedure.

#### Secondary Outcomes

**Description:** 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).

**Measure:** Post-Operative Sensitivity

**Time Frame:** One week (±2 days) after intervention.

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 35 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Post Operative Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### Misc Info Module

- Version Holder: 2024-05-31
