Association of Two Desensitizing Protocols to Control Dentinal Hypersensitivity in Non-carious Lesions

Dental Hypersensitivity Clinical Trial

Official title:

Association of Two Desensitizing Protocols to Control Dentinal Hypersensitivity in Non-carious Lesions: A Randomized, Double-blind Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04642001
• Other study ID #: UFPara-009
• Status: Completed
• Phase: N/A
• Start date: August 7, 2019
• Est. completion date: November 5, 2020

Study information

• Verified date: November 2020
• Source: Universidade Federal do Para
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 5, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Dental Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Photon Laser III-DMC (without radiation emission) + My First- Colgate
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 / GSK
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.

Radiation:
• Photon Laser III-DMC (with irradiation emission) + My First- Colgate
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.

Combination Product:
• Photon Laser III-DMC (with irradiation emission) +Sensodyne® Rapid Relief / GSK
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.

Locations

Country	Name	City	State
Brazil	Universidade Federal do Pará	Belém	Pará

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Para

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days after the end of treatment