Sensitive DentinNCT06202495
Dentine Hypersensitivity Treated With Laser and Fluoride.
A study testing Laser and Fluoride and Fluoride in people with Sensitive Dentin, run by University of Pavia at 1 site in Italy.
Trial summary
The aim of the present report is to evaluate the amino fluoride gel with or without application of diode laser on pain due to dentine hypersensitivity. NRS (numerical rating scale) index will be used to evaluate the pain suffered by each patient after cold air blow stimulus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensitive Dentin
- What is being tested?
- Laser and Fluoride and Fluoride
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2024to 10 Jul 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Teeth in good periodontal health
- Good oral hygiene
- Dentine hypersensitivity: NRS (Numerical Rating Scale) ≥ 3
Who cannot join
- Teeth local disease or fractures in treatment area
- Irreversible teeth necrosis or pulpitis
- Definitive restorations or veneers
- Recent use of painkillers or anti-inflammatory drugs,
- Treatment for dentine Hypersensitivity less than 6 months before the study start
- Therapies contraindication
Trial locations and contacts
1 site in 1 country.
Italy1 site
A.O. Mater Domini, U.O. Odontoiatria, University of Catanzaro "Magna Græcia".
Catanzaro
About this study
Official title: Dentine Hypersensitivity Treated With Diode Laser and Amino Fluoride: A Randomized Clinical Trial
The aim of the present report is to evaluate the amino fluoride gel with or without application of diode laser on pain due to dentine hypersensitivity.
NRS (numerical rating scale) index will be used to evaluate the pain suffered by each patient after cold air blow stimulus.
After treatment application, the follow-up timing planned for each patient will be at 1 week, 1 month, 3 months and 6 months
Read the detailed description
The aim of the present report is to evaluate the amino fluoride gel with or without application of diode laser on pain due to dentine hypersensitivity.
The study is designed with a split mouth design. NRS (numerical rating scale) index will be used to evaluate the pain suffered by each patient. The pain response will be stimulated by thermal urge (cold air blow). Teeth will be divided in two groups. The treatment group, treated with 980nm diode laser and amino fluoride gel; the control group, treated only with amino fluoride gel.
The follow-up timing planned for each patient will be at 1 week, 1 month, 3 months and 6 months. In these follow-up sessions a revaluation of the pain response is performed using the NRS index.
- Conditions
- Sensitive Dentin
- Being tested
- Laser and Fluoride, Fluoride
- Keywords
- Dentine hypersensitivity, fluoride, laser
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser and FluorideDevice
topic application of amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States) in association 980nm diode laser (doctor smile wiser by Lambda s.p.a. Via dell'Impresa, 1, 36040 Brendola VI, Italy) 1.5 W, pulsed mode 2 mm from tooth surface
FluorideOther
topic application of amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States)
| Study group | Role | What they receive |
|---|---|---|
| Laser and Fluoride | Experimental | The treatment group will be treated with amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States) in association 980nm diode laser (doctor smile wiser by Lambda s.p.a. Via dell'Impresa, 1, 36040 Brendola VI, Italy) 1.5 W, pulsed mode 2 mm from tooth surface. For treatment will be used 400 μm diameter and 5 mm long tips of for 4 minutes Receives: Device: Laser and Fluoride |
| Fluoride | Active comparator | The control group will be treated with amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States) for 4 minutes. Receives: Other: Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS (numerical rating scale)
The dentine hypersensitivity will be evaluated with the Numerical Rating Scale ( NRS ), where 0 meant pain absence and 10 a unbearable pain (Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, et al. Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011;41(6):1073-93.)
Measured: Before treatment and 1 week, 1 month, 3 months, 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start15 Jan 2024
- Primary completion5 Jul 2024 (estimated)
- Study completion10 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitive DentinStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS PhD MSc, Principal investigator, Unit of Dental Hygiene - Section of Dentistry - Dep of Clin Surg Diagn Ped Sci - University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202495
- Sponsor's protocol ID
- 2024-FLUORIDELASER
- Status last verified
- Feb 2024
- First submitted
- 1 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dentine Hypersensitivity Treated With Diode Laser and Amino Fluoride: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06202495
- Acronym / sponsor ID
- 2024-FLUORIDELASER
- Conditions
- Sensitive Dentin
- Keywords
- Dentine hypersensitivity, fluoride, laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 5 Jul 2024 (estimated)
- Study completion
- 10 Jul 2024 (estimated)
- First posted
- 11 Jan 2024 (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.
The aim of the present report is to evaluate the amino fluoride gel with or without application of diode laser on pain due to dentine hypersensitivity.
NRS (numerical rating scale) index will be used to evaluate the pain suffered by each patient after cold air blow stimulus.
After treatment application, the follow-up timing planned for each patient will be at 1 week, 1 month, 3 months and 6 months
Detailed description
The aim of the present report is to evaluate the amino fluoride gel with or without application of diode laser on pain due to dentine hypersensitivity.
The study is designed with a split mouth design. NRS (numerical rating scale) index will be used to evaluate the pain suffered by each patient. The pain response will be stimulated by thermal urge (cold air blow). Teeth will be divided in two groups. The treatment group, treated with 980nm diode laser and amino fluoride gel; the control group, treated only with amino fluoride gel.
The follow-up timing planned for each patient will be at 1 week, 1 month, 3 months and 6 months. In these follow-up sessions a revaluation of the pain response is performed using the NRS index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser and Fluoride | Experimental | Device: Laser and FluorideThe treatment group will be treated with amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States) in association 980nm diode laser (doctor smile wiser by Lambda s.p.a. Via dell'Impresa, 1, 36040 Brendola VI, Italy) 1.5 W, pulsed mode 2 mm from tooth surface. For treatment will be used 400 μm diameter and 5 mm long tips of for 4 minutes |
| Fluoride | Active comparator | Other: FluorideThe control group will be treated with amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States) for 4 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Teeth in good periodontal health
- Good oral hygiene
- Dentine hypersensitivity: NRS (Numerical Rating Scale) ≥ 3
Key exclusion criteria (6 listed)
- Teeth local disease or fractures in treatment area
- Irreversible teeth necrosis or pulpitis
- Definitive restorations or veneers
- Recent use of painkillers or anti-inflammatory drugs,
- Treatment for dentine Hypersensitivity less than 6 months before the study start
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 |
|---|---|---|
| Laser and Fluoridetopic application of amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States) in association 980nm diode laser (doctor smile wiser by Lambda s.p.a. Via dell'Impresa, 1, 36040 Brendola VI, Italy) 1.5 W, pulsed mode 2 mm from tooth surface | Device | Laser and Fluoride |
| Fluoridetopic application of amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States) | Other | Fluoride |
Primary outcome
NRS (numerical rating scale)
Time frame: Before treatment and 1 week, 1 month, 3 months, 6 months after treatment
The dentine hypersensitivity will be evaluated with the Numerical Rating Scale ( NRS ), where 0 meant pain absence and 10 a unbearable pain (Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, et al. Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011;41(6):1073-93.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Andrea Scribante, DDS PhD MSc principal investigator
Unit of Dental Hygiene - Section of Dentistry - Dep of Clin Surg Diagn Ped Sci - University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser and Fluoride and Fluoride in people with Sensitive Dentin, run by University of Pavia at 1 site in Italy.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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 Italy. 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. 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?
Results are not available in the source record.
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?
NRS (numerical rating scale) (time frame: Before treatment and 1 week, 1 month, 3 months, 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.