Effect of Diode Laser on Sensitive NCCLs Prior to Composite Restoration

Dentin Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05501691
• Other study ID #: 0048-06/2022
• Secondary ID: IORG0008839
• Status: Completed
• Phase: N/A
• Start date: October 4, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: October 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

Other:
• Placebo
Laser Simulation

Radiation:
• 445 nm Diode Laser Wavelength
The Axial Surface of Class V Cavity will be Irradiated Using a 445 nm Diode Laser Wavelength
• 660 nm Diode Laser Wavelength
The Axial Surface of Class V Cavity will be Irradiated Using a 660 nm Diode Laser Wavelength
• 970 nm Diode Laser Wavelength
The Axial Surface of Class V Cavity will be Irradiated Using a 970 nm Diode Laser Wavelength

Locations

Country	Name	City	State
Egypt	Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Clinically Assess Change in Dentin Hypersensitivity Between Baseline and 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.