Skip to content

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05501691
Enrollment
9
Registered
2022-08-15
Start date
2022-10-04
Completion date
2025-04-01
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin Hypersensitivity

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.

Interventions

OTHERPlacebo

Laser Simulation

RADIATION445 nm Diode Laser Wavelength

Irradiated Using a 445 nm Diode Laser Wavelength

RADIATION660 nm Diode Laser Wavelength

Irradiated Using a 660 nm Diode Laser Wavelength

RADIATION970 nm Diode Laser Wavelength

Irradiated Using a 970 nm Diode Laser Wavelength

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes 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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
45 Years to 64 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Dentin Hypersensitivity Assessed from Baseline to 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.

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026