Effect of Diode Laser on Sensitive NCCLs Prior to Composite Restoration

Not Applicable

Completed

• Conditions: Dentin Hypersensitivity
• Interventions: Other: Placebo; Radiation: 660 nm Diode Laser Wavelength; Radiation: 445 nm Diode Laser Wavelength; Radiation: 970 nm Diode Laser Wavelength

• Registration Number: NCT05501691
• Lead Sponsor: Alexandria University

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.

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 Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-12
• Study First Posted: 2022-08-15
• Status Verified: 2022-10
• Study Start: 2022-10-04
• Primary Completion: 2023-06-01
• Study Completion: 2023-07-01
• Last Update Submitted: 2023-07-30
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Laser Simulation
660 nm	660 nm Diode Laser Wavelength	660 nm Diode Laser Wavelength (SiroLaser Blue)
445 nm	445 nm Diode Laser Wavelength	445 nm Diode Laser Wavelength (SiroLaser Blue)
970 nm	970 nm Diode Laser Wavelength	970 nm Diode Laser Wavelength (SiroLaser Blue)

Primary Outcome Measures

Name	Time	Method
To Clinically Assess Change in Dentin Hypersensitivity Between Baseline and After Exposure to Diode Laser Radiation.	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.

Trial Locations

Locations (1)

Dentistry; 🇪🇬 Alexandria, Egypt