Dentin HypersensitivityNCT05501691
Effect of Diode Laser on Sensitive NCCLs Prior to Composite Restoration, Dentin Bonding, and Clinical Durability of Composite Restorations.
A study testing 445 nm Diode Laser Wavelength, 660 nm Diode Laser Wavelength and 970 nm Diode Laser Wavelength in people with Dentin Hypersensitivity, run by Alexandria University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- 445 nm Diode Laser Wavelength, 660 nm Diode Laser Wavelength and 970 nm Diode Laser Wavelength
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Oct 2022to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Placebo, 445 nm Diode Laser Wavelength, 660 nm Diode Laser Wavelength, 970 nm Diode Laser Wavelength
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Laser Simulation
445 nm Diode Laser WavelengthRadiation
Irradiated Using a 445 nm Diode Laser Wavelength
660 nm Diode Laser WavelengthRadiation
Irradiated Using a 660 nm Diode Laser Wavelength
970 nm Diode Laser WavelengthRadiation
Irradiated Using a 970 nm Diode Laser Wavelength
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Laser Simulation Receives: Other: Placebo |
| 445 nm | Experimental | 445 nm Diode Laser Wavelength (SiroLaser Blue) Receives: Radiation: 445 nm Diode Laser Wavelength |
| 660 nm | Experimental | 660 nm Diode Laser Wavelength (SiroLaser Blue) Receives: Radiation: 660 nm Diode Laser Wavelength |
| 970 nm | Experimental | 970 nm Diode Laser Wavelength (SiroLaser Blue) Receives: Radiation: 970 nm Diode Laser Wavelength |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
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.
Measured: Time frame: Restorations are evaluated for esthetic, functional, and biological properties over follow-up periods of 6 months, 12 months, and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start4 Oct 2022
- Primary completion1 Feb 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raghda Hegazy, Alexandria University
- Investigators
- Raghda A Hegazy, Bachelor, Principal investigator, Pharos UniversityEl Sayed M Mahmoud, Professor, Study chair, Alexandria UniversityAhmed A Holiel, Lecturer, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501691
- Sponsor's protocol ID
- 0048-06/2022
- Other IDs
- IORG0008839
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2022
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holiel AA, Hegazy RA, Sedek EM. Effect of diode laser on dentin surface properties, adhesive performance, and clinical outcomes of non-carious cervical lesion restorations: A 24-month split-mouth randomized controlled trial. J Dent. 2026 May;168:106629. doi: 10.1016/j.jdent.2026.106629. Epub 2026 Mar 12.
PubMed 41831557Hegazy RA, Mahmoud EM, Holiel AA. EFFECT OF LOW-LEVEL DIODE LASER ON DENTIN TOPOGRAPHY AND SYMPTOMATIC NONCARIOUS CERVICAL LESIONS PRIOR TO COMPOSITE RESTORATIONS: A SPLIT-MOUTH RANDOMIZED CONTROLLED TRIAL. J Evid Based Dent Pract. 2024 Jun;24(2):101969. doi: 10.1016/j.jebdp.2024.101969. Epub 2024 Jan 17.
PubMed 38821658
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05501691
- Acronym / sponsor ID
- 0048-06/2022
- Conditions
- Dentin Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboLaser Simulation |
| 445 nm | Experimental | Radiation: 445 nm Diode Laser Wavelength445 nm Diode Laser Wavelength (SiroLaser Blue) |
| 660 nm | Experimental | Radiation: 660 nm Diode Laser Wavelength660 nm Diode Laser Wavelength (SiroLaser Blue) |
| 970 nm | Experimental | Radiation: 970 nm Diode Laser Wavelength970 nm Diode Laser Wavelength (SiroLaser Blue) |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboLaser Simulation | Other | Placebo |
| 445 nm Diode Laser WavelengthIrradiated Using a 445 nm Diode Laser Wavelength | Radiation | 445 nm |
| 660 nm Diode Laser WavelengthIrradiated Using a 660 nm Diode Laser Wavelength | Radiation | 660 nm |
| 970 nm Diode Laser WavelengthIrradiated Using a 970 nm Diode Laser Wavelength | Radiation | 970 nm |
Primary outcome
Change in Dentin Hypersensitivity Assessed from Baseline to After Exposure to Diode Laser Radiation.
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.
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.
1 secondary outcome
Clinical assessment for esthetic, functional, and biological responses to restorative materials.
Time frame: Time frame: Restorations are evaluated for esthetic, functional, and biological properties over follow-up periods of 6 months, 12 months, and 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Derived from this study: PubMed 41831557Holiel AA, Hegazy RA, Sedek EM. Effect of diode laser on dentin surface properties, adhesive performance, and clinical outcomes of non-carious cervical lesion restorations: A 24-month split-mouth randomized controlled trial. J Dent. 2026 May;168:106629. doi: 10.1016/j.jdent.2026.106629. Epub 2026 Mar 12.
- Derived from this study: PubMed 38821658Hegazy RA, Mahmoud EM, Holiel AA. EFFECT OF LOW-LEVEL DIODE LASER ON DENTIN TOPOGRAPHY AND SYMPTOMATIC NONCARIOUS CERVICAL LESIONS PRIOR TO COMPOSITE RESTORATIONS: A SPLIT-MOUTH RANDOMIZED CONTROLLED TRIAL. J Evid Based Dent Pract. 2024 Jun;24(2):101969. doi: 10.1016/j.jebdp.2024.101969. Epub 2024 Jan 17.
- Individual participant dataSharing planned: No
Related trials for Dentin Hypersensitivity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raghda A Hegazy, Bachelor principal investigator
Pharos University
El Sayed M Mahmoud, Professor study chair
Alexandria University
Ahmed A Holiel, Lecturer study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 445 nm Diode Laser Wavelength, 660 nm Diode Laser Wavelength and 970 nm Diode Laser Wavelength in people with Dentin Hypersensitivity, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dentin Hypersensitivity Assessed from Baseline to After Exposure to Diode Laser Radiation. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05501691, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.