NCT06418958

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
14mo left

Started Sep 2025

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Sep 2025Jul 2027

First Submitted

Initial submission to the registry

May 2, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2027

Expected
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

November 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

May 2, 2024

Last Update Submit

November 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Temperature Change

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

    During restorative procedure.

Secondary Outcomes (1)

  • Post-Operative Sensitivity

    One week (±2 days) after intervention.

Study Arms (2)

Blue Light

ACTIVE COMPARATOR

Light-curing procedure performed using blue light emission.

Device: Blue Light

Red Light

EXPERIMENTAL

Light-curing procedure performed using red light emission.

Device: Red Light

Interventions

Red LightDEVICE

Light Curing with Red Light

Red Light

Light Curing with Blue Light

Blue Light

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I classification
  • Fully erupted pre-molar(s);
  • Absence of caries;
  • Absence of restoration.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida College of Dentistry Dental Clinical Research Unit

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2024

First Posted

May 17, 2024

Study Start

September 22, 2025

Primary Completion (Estimated)

June 25, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

November 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations