Effect of Diode Laser on Sensitive NCCLs Prior to Composite Restoration, Dentin Bonding, and Clinical Durability of Composite Restorations.

NCT05501691 | Completed

• 2 other identifiers: 0048-06/2022IORG0008839
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the efficacy of three diode laser wavelengths 445 nm, 660 nm, 970 nm when applied just before placement of composite restoration on reducing postoperative sensitivity from Non-carious cervical lesions (NCCLs) with class V cavity preparation.

Conditions

Dentin Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Change in Dentin Hypersensitivity Assessed from Baseline to After Exposure to Diode Laser Radiation.

  Dentin Hypersensitivity is Determined using Cold Stimulus. Utilizing Visual Analog Scale (VAS) Reading 0-10 Where 0 is No Pain, While 10 is the Most Experienced Pain.

  Change in Pain Scores From Baseline on the Visual Analog Scale at Day 1, Day 14, Followed by 1,3, and 6 Month Postoperatively.

Secondary Outcomes (1)

• Clinical assessment for esthetic, functional, and biological responses to restorative materials.

  Time frame: Restorations are evaluated for esthetic, functional, and biological properties over follow-up periods of 6 months, 12 months, and 24 months.

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Laser Simulation

Other: Placebo

445 nm

EXPERIMENTAL

445 nm Diode Laser Wavelength (SiroLaser Blue)

Radiation: 445 nm Diode Laser Wavelength

660 nm

EXPERIMENTAL

660 nm Diode Laser Wavelength (SiroLaser Blue)

Radiation: 660 nm Diode Laser Wavelength

970 nm

EXPERIMENTAL

970 nm Diode Laser Wavelength (SiroLaser Blue)

Radiation: 970 nm Diode Laser Wavelength

Interventions

Placebo OTHER

Laser Simulation

Placebo

445 nm Diode Laser Wavelength RADIATION

Irradiated Using a 445 nm Diode Laser Wavelength

445 nm

660 nm Diode Laser Wavelength RADIATION

Irradiated Using a 660 nm Diode Laser Wavelength

660 nm

970 nm Diode Laser Wavelength RADIATION

Irradiated Using a 970 nm Diode Laser Wavelength

970 nm

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• NCCLs on the Buccal Surface of Teeth, Maxilla, or Mandible.
• Preoperative VAS Score \> 2.
• Good Oral Hygiene. Score (0-1.2).
• Teeth Must be Vital.

You may not qualify if:

• Teeth with a History of Trauma, Dental caries, Defective Restoration, Pulpitis, Occlusal Restoration.
• Teeth with Periodontal Disease or History of Surgical Procedure.
• Use of Desensitizing Toothpaste or Solutions in the Past 3 Month.
• Patients Taking Analgesics within 72 h Before Sensitivity Testing.
• Patients with Known Allergic Reactions Against Any Material to be Used.
• Patients with a History of Psychological Diseases and those Taking Antipsychotic Medications.
• Pregnancy or Nursing.
• Unwillingness of the Patient to the Treatment Procedure.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Dentistry

Alexandria, Egypt

Location

Related Publications (1)

• Hegazy RA, Mahmoud EM, Holiel AA. EFFECT OF LOW-LEVEL DIODE LASER ON DENTIN TOPOGRAPHY AND SYMPTOMATIC NONCARIOUS CERVICAL LESIONS PRIOR TO COMPOSITE RESTORATIONS: A SPLIT-MOUTH RANDOMIZED CONTROLLED TRIAL. J Evid Based Dent Pract. 2024 Jun;24(2):101969. doi: 10.1016/j.jebdp.2024.101969. Epub 2024 Jan 17.

  PMID: 38821658 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Raghda A Hegazy, Bachelor

  Pharos University

  PRINCIPAL INVESTIGATOR

• El Sayed M Mahmoud, Professor

  Alexandria University

  STUDY CHAIR

• Ahmed A Holiel, Lecturer

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The allocation will be hidden from patients, and they will not know which teeth are lased and which will receive the placebo treatment. In addition, for blinding, the restoration procedure is performed by one person, and the cold test is performed by another person who is unaware of the distribution. Furthermore, the statistician will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: In this randomized controlled clinical trial, patients with NCCLs will be included (four teeth in each participant). The teeth will be randomly assigned into four groups according to diode laser irradiation wavelength Group 1 (placebo) laser simulation, Group 2 (445 nm) diode laser wavelength, Group 3 (660 nm) diode laser wavelength, and Group 4 (970 nm) diode laser wavelength.

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 15, 2022
• Study Start: October 4, 2022
• Primary Completion: February 1, 2025
• Study Completion: April 1, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)