Dentin SensitivityPhase 1/2NCT04407702
Control of Pain Due to Dentin Hypersensitivity in Individuals With Molar-incisor Hypomineralization
A Phase 1/2 study testing Hygiene Instructions, Sealant application and Low-level Laser in people with Dentin Sensitivity and Molar Incisor Hypomineralization, run by University of Nove de Julho.
Trial summary
Background: Dentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the occurrence of DH: 1) the dentin must be exposed and 2) the dentinal tubules must be open and connected to the pulp. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity, Molar Incisor Hypomineralization
- What is being tested?
- Hygiene Instructions, Sealant application and Low-level Laser
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 10 Dec 2021
- Phase
- Phase 1/2
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 35 years;
- Good overall health;
- At least one tooth with MIH and DH reported in the cervical region with sensitivity equal to or greater than 4 on the VAS.
Who cannot join
- Active caries or defective restorations on the tooth to be analyzed;
- Sufficient dentin loss that requires restorative treatment or periodontal surgery;
- Having undergone any professional desensitizing treatment in the previous six months;
- Having used a desensitizing paste in the previous three months;
- Use of anti-inflammatory drugs or analgesics at the time of recruitment;
- Currently pregnant or nursing.
About this study
Official title: Control of Pain Due to Dentin Hypersensitivity in Individuals With Molar-incisor Hypomineralization: Study Protocol for a Randomized, Controlled, Clinical Trial
Background: Dentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the occurrence of DH: 1) the dentin must be exposed and 2) the dentinal tubules must be open and connected to the pulp. Molar-incisor hypomineralization (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The control of tooth sensitivity is fundamental to the successful treatment of MIH.
Objective: The aim of the proposed randomized, controlled, clinical trial is to evaluate the effectiveness of different protocols for the control of DH in patients with teeth affected by MIH.
Read more
Methods: One hundred forty patients who meet the inclusion criteria will be allocated to four groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be sealed with Permaseal (Ultradent). In Group 3, sensitive teeth will receive low-level laser (LLL) (AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil). In Group 4, sensitive teeth will be treated with both LLL and Permaseal (Ultradent). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated one week, one month, three months and six months after the treatments.
Discussion: This study will enable the determination of differences in the effectiveness of the proposed treatments as well as differences among the evaluation times for each proposed treatment.
- Being tested
- Hygiene Instructions, Sealant application, Low-level Laser
- Medical subject headings
- Dentin Sensitivity, Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hygiene InstructionsOther
Two weeks prior to the onset of the study, the volunteers will undergo a wash-out period, in which they will only use oral hygiene products donated by the researchers. These products will be used through to the end of the study. The oral hygiene kit will contain a soft-bristle toothbrush (Professional Lab Series, Colgate Palmolive), fluoride toothpaste with no desensitizing agent (Elmex) and dental floss (Colgate). The participants will be extensively trained with regards to all procedures involved in the experiment.
Sealant applicationProcedure or surgery
The teeth to be sealed will be isolated and 35% phosphoric acid will be applied for 20 seconds, followed by rinsing and drying the dental surfaces. A thin layer of PermaSeal will be applied to the tooth surface for 5 seconds and photopolymerized for 20 seconds. The occlusion will then be evaluated.
Low-level LaserRadiation
Irradiation with AsGaAl laser at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil) with relative isolation. The power will be set to 100 mW; energy density will be 35 J/cm2 (considering a spot size of 0.028 cm2 of the equipment) and the dose will be 1 J per point. Irradiation will be performed on a cervical point, an apical point and a point precisely over the lesion, totaling a dose of 3 J. Treatment will be performed in three sessions with a 72-hour interval between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | The volunteers in this group will receive the same hygiene instructions as the other groups and will undergo both treatments, except that water will be used instead of the sealant and the laser device will be set to a power of 0 W. In other words, the same irradiation procedure will be performed but without the emission of light. Receives: Other: Hygiene Instructions |
| Sealant Group | Experimental | The volunteers in this group will receive treatment with sealant (Permaseal - Ultradent), which is a photopolymerizable methacrylate-based resin. Receives: Other: Hygiene Instructions; Procedure: Sealant application |
| Low-Level Laser Group | Experimental | The volunteers in this group will receive irradiation with AsGaAl laser at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil) with relative isolation. Receives: Other: Hygiene Instructions; Radiation: Low-level Laser |
| Low Level Laser + Sealant Group | Experimental | The volunteers in this group will receive the same irradiation administered to Low-level Laser Group. During the last session, these volunteers will also receive the same sealant applied in Sealant Group. Receives: Other: Hygiene Instructions; Procedure: Sealant application; Radiation: Low-level Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain evaluated through a Visual Analog Scale (VAS)
The researcher will assess the sensitive tooth using cold air from the triple syringe (2 s of compressed air at a pressure of approximately 40 psi with the syringe perpendicular to the tooth surface at a distance of approximately 0.5 cm). Neighboring teeth will be protected with cotton rolls or the examiner's fingers9. The volunteer will then indicate a whole number between 0 (absence of pain) to 10 (worst pain possible) on the 10-cm VAS scale that best describes his/her perception of pain.
Measured: Baseline, one week, one month, three months and six months after the final treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Jan 2021 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion10 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentin SensitivityStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407702
- Sponsor's protocol ID
- Hypersensitivity
- Status last verified
- Nov 2020
- First submitted
- 25 May 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets (Excel spreadsheets) generated from this protocol will be available with the corresponding author (Sandra Kalil Bussadori - sandra.skb@gmail.com) at a reasonable request. However, reuse of this data will not be allowed for people who are not authors of this paper.
Publications
Sobral APT, Santos EM, Aranha AC, Soares PV, Moriyama CM, Goncalves MLL, Ribeiro RA, Motta LJ, Horliana ACRT, Fernandes KPS, Mesquita-Ferrari RA, Bussadori SK. The control of pain due to dentin hypersensitivity in individuals with molar-incisor hypomineralisation: a protocol for a randomised controlled clinical trial. BMJ Open. 2021 Mar 10;11(3):e044653. doi: 10.1136/bmjopen-2020-044653.
PubMed 33692185
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Pain Due to Dentin Hypersensitivity in Individuals With Molar-incisor Hypomineralization: Study Protocol for a Randomized, Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT04407702
- Acronym / sponsor ID
- Hypersensitivity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 10 Dec 2021 (estimated)
- First posted
- 29 May 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.
Background: Dentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the occurrence of DH: 1) the dentin must be exposed and 2) the dentinal tubules must be open and connected to the pulp. Molar-incisor hypomineralization (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The control of tooth sensitivity is fundamental to the successful treatment of MIH.
Objective: The aim of the proposed randomized, controlled, clinical trial is to evaluate the effectiveness of different protocols for the control of DH in patients with teeth affected by MIH.
Methods: One hundred forty patients who meet the inclusion criteria will be allocated to four groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be sealed with Permaseal (Ultradent). In Group 3, sensitive teeth will receive low-level laser (LLL) (AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil). In Group 4, sensitive teeth will be treated with both LLL and Permaseal (Ultradent). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated one week, one month, three months and six months after the treatments.
Discussion: This study will enable the determination of differences in the effectiveness of the proposed treatments as well as differences among the evaluation times for each proposed treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: Hygiene InstructionsThe volunteers in this group will receive the same hygiene instructions as the other groups and will undergo both treatments, except that water will be used instead of the sealant and the laser device will be set to a power of 0 W. In other words, the same irradiation procedure will be performed but without the emission of light. |
| Sealant Group | Experimental | Other: Hygiene Instructions, Procedure: Sealant applicationThe volunteers in this group will receive treatment with sealant (Permaseal - Ultradent), which is a photopolymerizable methacrylate-based resin. |
| Low-Level Laser Group | Experimental | Other: Hygiene Instructions, Radiation: Low-level LaserThe volunteers in this group will receive irradiation with AsGaAl laser at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil) with relative isolation. |
| Low Level Laser + Sealant Group | Experimental | Other: Hygiene Instructions, Procedure: Sealant application, Radiation: Low-level LaserThe volunteers in this group will receive the same irradiation administered to Low-level Laser Group. During the last session, these volunteers will also receive the same sealant applied in Sealant Group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 35 years;
- Good overall health;
- At least one tooth with MIH and DH reported in the cervical region with sensitivity equal to or greater than 4 on the VAS.
Key exclusion criteria (6 listed)
- Active caries or defective restorations on the tooth to be analyzed;
- Sufficient dentin loss that requires restorative treatment or periodontal surgery;
- Having undergone any professional desensitizing treatment in the previous six months;
- Having used a desensitizing paste in the previous three months;
- Use of anti-inflammatory drugs or analgesics at the time of recruitment;
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 |
|---|---|---|
| Hygiene InstructionsTwo weeks prior to the onset of the study, the volunteers will undergo a wash-out period, in which they will only use oral hygiene products donated by the researchers. These products will be used through to the end of the study. The oral hygiene kit will contain a soft-bristle toothbrush (Professional Lab Series, Colgate Palmolive), fluoride toothpaste with no desensitizing agent (Elmex) and dental floss (Colgate). The participants will be extensively trained with regards to all procedures involved in the experiment. | Other | Control Group, Low Level Laser + Sealant Group, Low-Level Laser Group, Sealant Group |
| Sealant applicationThe teeth to be sealed will be isolated and 35% phosphoric acid will be applied for 20 seconds, followed by rinsing and drying the dental surfaces. A thin layer of PermaSeal will be applied to the tooth surface for 5 seconds and photopolymerized for 20 seconds. The occlusion will then be evaluated. | Procedure or surgery | Low Level Laser + Sealant Group, Sealant Group |
| Low-level LaserIrradiation with AsGaAl laser at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil) with relative isolation. The power will be set to 100 mW; energy density will be 35 J/cm2 (considering a spot size of 0.028 cm2 of the equipment) and the dose will be 1 J per point. Irradiation will be performed on a cervical point, an apical point and a point precisely over the lesion, totaling a dose of 3 J. Treatment will be performed in three sessions with a 72-hour interval between sessions. | Radiation | Low Level Laser + Sealant Group, Low-Level Laser Group |
Primary outcome
Change in pain evaluated through a Visual Analog Scale (VAS)
Time frame: Baseline, one week, one month, three months and six months after the final treatment session.
The researcher will assess the sensitive tooth using cold air from the triple syringe (2 s of compressed air at a pressure of approximately 40 psi with the syringe perpendicular to the tooth surface at a distance of approximately 0.5 cm). Neighboring teeth will be protected with cotton rolls or the examiner's fingers9. The volunteer will then indicate a whole number between 0 (absence of pain) to 10 (worst pain possible) on the 10-cm VAS scale that best describes his/her perception of pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Derived from this study: PubMed 33692185Sobral APT, Santos EM, Aranha AC, Soares PV, Moriyama CM, Goncalves MLL, Ribeiro RA, Motta LJ, Horliana ACRT, Fernandes KPS, Mesquita-Ferrari RA, Bussadori SK. The control of pain due to dentin hypersensitivity in individuals with molar-incisor hypomineralisation: a protocol for a randomised controlled clinical trial. BMJ Open. 2021 Mar 10;11(3):e044653. doi: 10.1136/bmjopen-2020-044653.
- Individual participant dataSharing planned: Yes. The datasets (Excel spreadsheets) generated from this protocol will be available with the corresponding author (Sandra Kalil Bussadori - sandra.skb@gmail.com) at a reasonable request. However, reuse of this data will not be allowed for people who are not authors of this paper.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hygiene Instructions, Sealant application and Low-level Laser in people with Dentin Sensitivity and Molar Incisor Hypomineralization, run by University of Nove de Julho.
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 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in pain evaluated through a Visual Analog Scale (VAS) (time frame: Baseline, one week, one month, three months and six months after the final treatment session.). 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 NCT04407702, which also lists 1 linked publication.
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 30 Nov 2020.