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

NCT ID: NCT05501691

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-04

Study Completion Date

2025-04-01

Brief Summary

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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.

Detailed Description

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In this randomized clinical trial, patients with NCCLs will be included (four teeth in each participant). After class V cavity preparation in the NCCLs, the teeth will be randomly assigned into four groups according to diode laser irradiation wavelength Group 1 (placebo) laser simulation and Group 2 (445 nm) diode laser wavelength, Group 3 (660 nm) diode laser wavelength, and Group 4 (970 nm) diode laser wavelength. Following laser irradiation, the universal self-etch adhesive will be applied and all the cavities will be restored with the same resin composite. Tooth sensitivity to a cold stimulus will be recorded using a visual analogue scale (VAS) before treatment and on follow-up days 1, 14 followed by 1, 3, and 6 month after treatment.

Conditions

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Dentin Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Placebo

Laser Simulation

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Laser Simulation

445 nm

445 nm Diode Laser Wavelength (SiroLaser Blue)

Group Type EXPERIMENTAL

445 nm Diode Laser Wavelength

Intervention Type RADIATION

Irradiated Using a 445 nm Diode Laser Wavelength

660 nm

660 nm Diode Laser Wavelength (SiroLaser Blue)

Group Type EXPERIMENTAL

660 nm Diode Laser Wavelength

Intervention Type RADIATION

Irradiated Using a 660 nm Diode Laser Wavelength

970 nm

970 nm Diode Laser Wavelength (SiroLaser Blue)

Group Type EXPERIMENTAL

970 nm Diode Laser Wavelength

Intervention Type RADIATION

Irradiated Using a 970 nm Diode Laser Wavelength

Interventions

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Placebo

Laser Simulation

Intervention Type OTHER

445 nm Diode Laser Wavelength

Irradiated Using a 445 nm Diode Laser Wavelength

Intervention Type RADIATION

660 nm Diode Laser Wavelength

Irradiated Using a 660 nm Diode Laser Wavelength

Intervention Type RADIATION

970 nm Diode Laser Wavelength

Irradiated Using a 970 nm Diode Laser Wavelength

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

45 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Raghda Hegazy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raghda A Hegazy, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Pharos University

El Sayed M Mahmoud, Professor

Role: STUDY_CHAIR

Alexandria University

Ahmed A Holiel, Lecturer

Role: STUDY_DIRECTOR

Alexandria University

Locations

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Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 38821658 (View on PubMed)

Other Identifiers

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IORG0008839

Identifier Type: OTHER

Identifier Source: secondary_id

0048-06/2022

Identifier Type: -

Identifier Source: org_study_id

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