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Pain Control in Dentin Hypersensitivity in Patients With MIH

Pain Control in Dentin Hypersensitivity in Patients With MIH: Study Protocol for a Randomized, Controlled, Clinical Trial

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04268238
Enrollment
140
Registered
2020-02-13
Start date
2020-03-20
Completion date
2020-12-20
Last updated
2020-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersensitivity Dentin

Brief summary

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.

Interventions

PROCEDUREHygiene Guidance

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.

RADIATIONLow Level Laser Application

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.

Sponsors

University of Nove de Julho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Study participants and the outcome assessor of sensitivity will be blind to the procedure. However, the researcher who will apply the products is not blind, due to the different forms of clinical manipulation of products.

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Be between 18 and 35 years old; * Present good general health; * Present at least one tooth with dentin hypersensitivity reported in the cervical region, which must have a graduated sensitivity equal to or greater than 4 in the VAS scale.

Exclusion criteria

* Present active caries lesions or restoration defects in the tooth to be analyzed; * Present sufficient dentin loss that requires restorative treatment or periodontal surgery; * Volunteers who underwent any professional desensitizer treatment in the last 6 months; * Volunteers who used desensitizing pastes in the 3 months; * Volunteers who were using anti-inflammatory or analgesic drugs at the time of recruitment; * Volunteers who are pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Evaluated by a Visual Analog Scale (VAS)Baseline, immediately after treatment, 1 week, 1, 3 and 6 months after treatment.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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026