Back to resultsEffect of Diode Laser on Sensitive NCCLs Prior to Composite Restoration
Primary Purpose
Dentin Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Placebo
445 nm Diode Laser Wavelength
660 nm Diode Laser Wavelength
970 nm Diode Laser Wavelength
Sponsored by
About this trial
This is an interventional supportive care trial for Dentin Hypersensitivity
Eligibility Criteria
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.
Sites / Locations
- Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
445 nm
660 nm
970 nm
Arm Description
Laser Simulation
445 nm Diode Laser Wavelength (SiroLaser Blue)
660 nm Diode Laser Wavelength (SiroLaser Blue)
970 nm Diode Laser Wavelength (SiroLaser Blue)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05501691
Brief Title
Effect of Diode Laser on Sensitive NCCLs Prior to Composite Restoration
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 4, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Laser Simulation
Arm Title
445 nm
Arm Type
Experimental
Arm Description
445 nm Diode Laser Wavelength (SiroLaser Blue)
Arm Title
660 nm
Arm Type
Experimental
Arm Description
660 nm Diode Laser Wavelength (SiroLaser Blue)
Arm Title
970 nm
Arm Type
Experimental
Arm Description
970 nm Diode Laser Wavelength (SiroLaser Blue)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Laser Simulation
Intervention Type
Radiation
Intervention Name(s)
445 nm Diode Laser Wavelength
Intervention Description
The Axial Surface of Class V Cavity will be Irradiated Using a 445 nm Diode Laser Wavelength
Intervention Type
Radiation
Intervention Name(s)
660 nm Diode Laser Wavelength
Intervention Description
The Axial Surface of Class V Cavity will be Irradiated Using a 660 nm Diode Laser Wavelength
Intervention Type
Radiation
Intervention Name(s)
970 nm Diode Laser Wavelength
Intervention Description
The Axial Surface of Class V Cavity will be Irradiated Using a 970 nm Diode Laser Wavelength
Primary Outcome Measure Information:
Title
To Clinically Assess Change in Dentin Hypersensitivity Between Baseline and After Exposure to Diode Laser Radiation.
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raghda A Hegazy, Bachelor
Organizational Affiliation
Pharos University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
El Sayed M Mahmoud, Professor
Organizational Affiliation
Alexandria University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed A Holiel, Lecturer
Organizational Affiliation
Alexandria University
Official's Role
Study Director
Facility Information:
Facility Name
Dentistry
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Diode Laser on Sensitive NCCLs Prior to Composite Restoration
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