A Phase 1/2 interventional study of Hygiene Guidance and Sealant Application in Hypersensitivity Dentin, sponsored by University of Nove de Julho. Status unknown. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-13.
Sponsored by University of Nove de Julho · Phase 1/2, Interventional, and Treatment
This study aims to evaluate the effectiveness of different protocols in controlling dentin hypersensitivity in patients with teeth affected by MIH. The subjects will be randomly designated in four experimental groups, according to different treatments. Pain will be assessed with the visual analog scale (Visual Analogue Scale - VAS), after stimulation with air from the triple syringe and and an exploratory probe at the time of (initial) recruitment, immediately after treatment, after 1 week and 1 month, 3 and 6 months after treatment.
283 studies on the registry are indexed under Dentin Sensitivity; 45 are open to participants now.
This study's planned enrollment of 140 is above the median of 60 across 274 interventional studies indexed under Dentin Sensitivity.
Browse Dentin Sensitivity studies →University of Nove de Julho is the lead sponsor of 239 studies on the registry; 51 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
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Exclusion Criteria:
Two weeks before the start of the study, the volunteers will go through a wash out period, where they should only use oral care products donated by the researchers, which should be used until the end of the study. The oral hygiene kit will contain 1 toothbrush (Professional Lab Series, Colgate Palmolive), 1 toothpaste without desensitizing agent, but with fluorine (Elmex) and 1 dental floss (Colgate). Afterwards, this group will receive no treatment. Instead of the sealant, water will be used and the laser will remain with power 0W, that is, there will be no light emission, giving the group the characteristic of the control group, no treatment.
Procedure: Hygiene Guidance
In this group, besides the instructions described in the control group, the teeth that will be sealed will be isolated. 35% phosphoric acid will be applied for 20 seconds and then it will be necessary to wash and dry the tooth surface. Apply a thin layer of PermaSeal (sealant) for 5 seconds to the tooth surface and light curing for 20 seconds.
Procedure: Hygiene Guidance · Procedure: Sealant Application
In this group, besides the instructions described in the control group, volunteers will receive irradiation with AsGaAl laser, wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP) with fixed power of 100mW, energy density of 35 J/cm2 (considering a spot size of 0.028 cm2 of this equipment), the dose will be 1 J per point. The irradiation will be performed at a cervical, an apical point and another point exactly on the injury, totaling a dose of 3J. Treatment should be performed in 3 sessions with an ideal 72-hour interval between them.
Procedure: Hygiene Guidance · Radiation: Low Level Laser Application
In this group, patients will receive the treatments described in Control group, Sealant group and Low Level Laser Group.
Procedure: Hygiene Guidance · Procedure: Sealant Application · Radiation: Low Level Laser Application
Two weeks before the start of the study, the volunteers will go through a wash out period, where they should only use oral care products donated by the researchers, which should be used until the end of the study. The oral hygiene kit will contain 1 toothbrush (Professional Lab Series, Colgate Palmolive), 1 toothpaste without desensitizing agent, but with fluorine (Elmex) and 1 dental floss (Colgate).
Permaseal (Ultradent) is an unloaded resin based on methacrylate and photopolymerizable. The teeth that will be sealed will be isolated. 35% phosphoric acid will be applied for 20 seconds and then it will be necessary to wash and dry the tooth surface. Apply a thin layer of PermaSeal for 5 seconds to the tooth surface and light curing for 20 seconds. After that, it is necessary to evaluate occlusion.
Volunteers will receive irradiation with AsGaAl laser, wavelength of 780nm (Laser XT Therapy, DMC, São Carlos, SP) with fixed power of 100mW, density of energy of 35 J/cm2 (considering a spot size of 0.028cm2 of this equipment), the dose will be 1 J per point. Irradiation will be performed at a cervical, an apical point, and another point exactly on the injury, totaling a dose of 3J. Treatment should be performed in 3 sessions with an ideal 72-hour interval between them.
Change in Pain Evaluated by a Visual Analog Scale (VAS)
Pain will be assessed with the visual analogue scale (Visual Analogue Scale - VAS), after stimulation with air from the triple syringe and an explorer probe.
Time frame: Baseline, immediately after treatment, 1 week, 1, 3 and 6 months after treatment.
No study locations are listed for this record.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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University of Nove de Julho