Dental HypersensitivityNCT04642001
Association of Two Desensitizing Protocols to Control Dentinal Hypersensitivity in Non-carious Lesions
A study testing Photon Laser III-DMC (without radiation emission) + My First- Colgate, Photon Laser III-DMC (without radiation emission) + Sensodyne® Rapid Relief / GSK and Photon Laser III-DMC (with irradiation emission) + My First- Colgate in people with Dental Hypersensitivity, run by Universidade Federal do Para at 1 site in Brazil.
Trial summary
This randomized, double-blind clinical trial evaluated the effect of photobimodulation associated with 8% strontium acetate in the treatment of dentin hypersensitivity in non-carious lesions and analyzed the risk factors with the patient's quality of life. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Hypersensitivity
- What is being tested?
- Photon Laser III-DMC (without radiation emission) + My First- Colgate, Photon Laser III-DMC (without radiation emission) + Sensodyne® Rapid Relief / GSK and Photon Laser III-DMC (with irradiation emission) + My First- Colgate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Aug 2019to 5 Nov 2020
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 to 50 years
- Good general health
- Dental sensitivity with response ≥ 4 on the 10 cm long visual analog scale (EVA)
- Presence of at least two hypersensitive teeth with a depth of up to 1 mm (measured with a millimeter probe)
- Exposed root surface caused by abrasion, erosion or gum recession
Who cannot join
- Volunteers using analgesic medication
- Presence of teeth with evidence of carious lesions, pulpitis, defective restorations and moderate or severe periodontal disease
- Patients who had undergone any whitening therapy or professional or homemade desensitizer in the last six months
- Patient with fixed orthodontic appliances
- Drug users or pregnant women were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Two Desensitizing Protocols to Control Dentinal Hypersensitivity in Non-carious Lesions: A Randomized, Double-blind Clinical Trial.
This randomized, double-blind clinical trial evaluated the effect of photobimodulation associated with 8% strontium acetate in the treatment of dentin hypersensitivity in non-carious lesions and analyzed the risk factors with the patient's quality of life.
- Conditions
- Dental Hypersensitivity
- Being tested
- Photon Laser III-DMC (without radiation emission) + My First- Colgate, Photon Laser III-DMC (without radiation emission) + Sensodyne® Rapid Relief / GSK, Photon Laser III-DMC (with irradiation emission) + My First- Colgate, Photon Laser III-DMC (with irradiation emission) +Sensodyne® Rapid Relief / GSK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon Laser III-DMC (without radiation emission) + My First- ColgateOther
Positioning of the FBM (Photon Laser III / DMC) without emitting radiation, the equipment's sound was mimicked with the Beep application (Foncannon Inc, Google, © 2018), followed by the use of fluoride-free toothpaste (My First- Colgate) and brushing three times a day.
Photon Laser III-DMC (without radiation emission) + Sensodyne® Rapid Relief / GSKOther
Positioning of FBM (Photon Laser III / DMC) without emitting radiation, the equipment's sound was mimicked with the Beep application (Foncannon Inc, Google, © 2018), followed by the application of toothpaste containing strontium acetate (Sensodyne® Rapid Relief / GSK) and brushing three times a day.
Photon Laser III-DMC (with irradiation emission) + My First- ColgateRadiation
Emission of FBM therapy (Photon Laser III / DMC), followed by the use of fluoride-free toothpaste (My First- Colgate) and brushing three times a day.
Photon Laser III-DMC (with irradiation emission) +Sensodyne® Rapid Relief / GSKCombination product
Emission of FBM therapy (Photon Laser III / DMC), followed by the application of toothpaste containing strontium acetate (Sensodyne® Rapid Relief / GSK) and brushing three times a day.
| Study group | Role | What they receive |
|---|---|---|
| Group G1 | Other | Photon Laser III-DMC (without radiation emission) + My First- Colgate Receives: Other: Photon Laser III-DMC (without radiation emission) + My First- Colgate |
| Group G2 | Experimental | Photon Laser III-DMC (without radiation emission) + Sensodyne® Rápido Alívio/GSK Receives: Other: Photon Laser III-DMC (without radiation emission) + Sensodyne® Rapid Relief / GSK |
| Group G3 | Experimental | Photon Laser III-DMC (with irradiation emission) + My First- Colgate Receives: Radiation: Photon Laser III-DMC (with irradiation emission) + My First- Colgate |
| Group G4 | Experimental | Photon Laser III-DMC (with irradiation emission) + Sensodyne® Rápido Alívio/GSK Receives: Combination Product: Photon Laser III-DMC (with irradiation emission) +Sensodyne® Rapid Relief / GSK |
What is being measured
The primary outcome is the main question the study is designed to answer.
dentin sensitivity
evaluation of dentinal sensitivity during treatment and one month after its end, by means of tactile and evaporative stimuli according to the visual analog scale with values from 0 to 10, with higher values indicating a worse level of pain.
Measured: 30 days after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start7 Aug 2019
- Primary completion15 Sep 2020
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental HypersensitivityStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Para
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecy Martins Silva, Universidade Federal do Para
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642001
- Sponsor's protocol ID
- UFPara-009
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Two Desensitizing Protocols to Control Dentinal Hypersensitivity in Non-carious Lesions: A Randomized, Double-blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT04642001
- Acronym / sponsor ID
- UFPara-009
- Conditions
- Dental Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 24 Nov 2020 (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 randomized, double-blind clinical trial evaluated the effect of photobimodulation associated with 8% strontium acetate in the treatment of dentin hypersensitivity in non-carious lesions and analyzed the risk factors with the patient's quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group G1 | Other | Other: Photon Laser III-DMC (without radiation emission) + My First- ColgatePhoton Laser III-DMC (without radiation emission) + My First- Colgate |
| Group G2 | Experimental | Other: Photon Laser III-DMC (without radiation emission) + Sensodyne® Rapid Relief / GSKPhoton Laser III-DMC (without radiation emission) + Sensodyne® Rápido Alívio/GSK |
| Group G3 | Experimental | Radiation: Photon Laser III-DMC (with irradiation emission) + My First- ColgatePhoton Laser III-DMC (with irradiation emission) + My First- Colgate |
| Group G4 | Experimental | Combination Product: Photon Laser III-DMC (with irradiation emission) +Sensodyne® Rapid Relief / GSKPhoton Laser III-DMC (with irradiation emission) + Sensodyne® Rápido Alívio/GSK |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 to 50 years
- Good general health
- Dental sensitivity with response ≥ 4 on the 10 cm long visual analog scale (EVA)
- Presence of at least two hypersensitive teeth with a depth of up to 1 mm (measured with a millimeter probe)
- Exposed root surface caused by abrasion, erosion or gum recession
Key exclusion criteria (5 listed)
- Volunteers using analgesic medication
- Presence of teeth with evidence of carious lesions, pulpitis, defective restorations and moderate or severe periodontal disease
- Patients who had undergone any whitening therapy or professional or homemade desensitizer in the last six months
- Patient with fixed orthodontic appliances
- Drug users or pregnant women were also excluded.
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 |
|---|---|---|
| Photon Laser III-DMC (without radiation emission) + My First- ColgatePositioning of the FBM (Photon Laser III / DMC) without emitting radiation, the equipment's sound was mimicked with the Beep application (Foncannon Inc, Google, © 2018), followed by the use of fluoride-free toothpaste (My First- Colgate) and brushing three times a day. | Other | Group G1 |
| Photon Laser III-DMC (without radiation emission) + Sensodyne® Rapid Relief / GSKPositioning of FBM (Photon Laser III / DMC) without emitting radiation, the equipment's sound was mimicked with the Beep application (Foncannon Inc, Google, © 2018), followed by the application of toothpaste containing strontium acetate (Sensodyne® Rapid Relief / GSK) and brushing three times a day. | Other | Group G2 |
| Photon Laser III-DMC (with irradiation emission) + My First- ColgateEmission of FBM therapy (Photon Laser III / DMC), followed by the use of fluoride-free toothpaste (My First- Colgate) and brushing three times a day. | Radiation | Group G3 |
| Photon Laser III-DMC (with irradiation emission) +Sensodyne® Rapid Relief / GSKEmission of FBM therapy (Photon Laser III / DMC), followed by the application of toothpaste containing strontium acetate (Sensodyne® Rapid Relief / GSK) and brushing three times a day. | Combination product | Group G4 |
Primary outcome
dentin sensitivity
Time frame: 30 days after the end of treatment
evaluation of dentinal sensitivity during treatment and one month after its end, by means of tactile and evaporative stimuli according to the visual analog scale with values from 0 to 10, with higher values indicating a worse level of pain.
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 27 Nov 2020.
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Molar-Incisor Hypomineralization (MIH)
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Effectiveness of Two Different Desensitizing Dental Varnishes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photon Laser III-DMC (without radiation emission) + My First- Colgate, Photon Laser III-DMC (without radiation emission) + Sensodyne® Rapid Relief / GSK and Photon Laser III-DMC (with irradiation emission) + My First- Colgate in people with Dental Hypersensitivity, run by Universidade Federal do Para at 1 site in Brazil.
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 5 inclusion and 5 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 27 Nov 2020. 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 Brazil. 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?
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?
dentin sensitivity (time frame: 30 days after the end of 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 27 Nov 2020.