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Completed

NCT Number: NCT05501691

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

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.

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Key information

Conditions

Dentin Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dentistry

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Placebo

Other

Laser Simulation

445 nm Diode Laser Wavelength

Radiation

Irradiated Using a 445 nm Diode Laser Wavelength

660 nm Diode Laser Wavelength

Radiation

Irradiated Using a 660 nm Diode Laser Wavelength

970 nm Diode Laser Wavelength

Radiation

Irradiated Using a 970 nm Diode Laser Wavelength

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    The restoration's esthetic assessment includes 1. surface luster, 2. surface staining, and 3. color stability and translucency.

    The functional assessment of the restoration includes 1. fracture and retention, 2. marginal adaptation, 3. wear, and 4. the patient's view

    . The biological category, ratings include 1. Postoperative sensitivity or hypersensitivity and tooth vitality, 2. Recurrence of carious, erosion, abrasion 3. Tooth integrity (enamel cracks) 4. Periodontal response 5. Adjacent mucosa 6. Oral and general health.

    Each criterion will be scored 1-5. Each score represents 1. clinically excellent/ very good, 2. clinically good, 3. clinically sufficient/ satisfactory, 4. clinically unsatisfactory, and 5. clinically poor.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Effect of Low-Level Diode Laser on Dentin Topography And Sensitive Non-Carious Cervical Lesions Prior to Composite Restoration, And Dentin Bonding And Clinical Durability of Composite Restorations (A Two Year Split-mouth Randomized Controlled Trial)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2022
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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