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

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)

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.

Study Overview

• Status: Completed
• Conditions: Dentin Hypersensitivity
• Intervention / Treatment: Other: Placebo; Radiation: 445 nm Diode Laser Wavelength; Radiation: 660 nm Diode Laser Wavelength; Radiation: 970 nm Diode Laser Wavelength

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Laser Simulation	Other: Placebo; Laser Simulation
Experimental: 445 nm; 445 nm Diode Laser Wavelength (SiroLaser Blue)	Radiation: 445 nm Diode Laser Wavelength; Irradiated Using a 445 nm Diode Laser Wavelength
Experimental: 660 nm; 660 nm Diode Laser Wavelength (SiroLaser Blue)	Radiation: 660 nm Diode Laser Wavelength; Irradiated Using a 660 nm Diode Laser Wavelength
Experimental: 970 nm; 970 nm Diode Laser Wavelength (SiroLaser Blue)	Radiation: 970 nm Diode Laser Wavelength; Irradiated Using a 970 nm Diode Laser Wavelength

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical assessment for esthetic, functional, and biological responses to restorative materials.	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.	Time frame: Restorations are evaluated for esthetic, functional, and biological properties over follow-up periods of 6 months, 12 months, and 24 months.

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Chair: El Sayed M Mahmoud, Professor, Alexandria University; Study Director: Ahmed A Holiel, Lecturer, Alexandria University; Principal Investigator: Raghda A Hegazy, Bachelor, Pharos university

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2022
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 9, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Immune System Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity
• Other Study ID Numbers: 0048-06/2022; IORG0008839 (Other Identifier: International No: Alexandria University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No