NCT04642001

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

1.1 years

First QC Date

November 11, 2020

Last Update Submit

November 23, 2020

Conditions

Dental Hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Group G1

OTHER

Photon Laser III-DMC (without radiation emission) + My First- Colgate

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

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

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

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

Interventions

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.

Group G1
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.

Group G2
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.

Group G3
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.

Group G4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Pará

Belém, Pará, 66075-110, Brazil

Location

MeSH Terms

Interventions

halofantrine

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

November 11, 2020

First Posted

November 24, 2020

Study Start

August 7, 2019

Primary Completion

September 15, 2020

Study Completion

November 5, 2020

Last Updated

November 27, 2020

Record last verified: 2020-11

Locations

BR(1)