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Effect of Laser and Potassium Nitrate Application on the Sensitivity Control in Bleached Teeth

Effect of Low-level Light Therapy Associated With Potassium Nitrate in the Control of Post-bleaching Dental Sensitivity: a Randomized, Double-blind, Split-mouth, Controlled Trial

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03434782
Enrollment
50
Registered
2018-02-15
Start date
2017-04-24
Completion date
2018-01-15
Last updated
2018-02-15

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

Conditions

Dentin Sensitivity

Brief summary

To investigate the effects of desensitizing agents on the dental bleaching process, testing the hypothesis that they may control dental sensitivity.

Detailed description

The objective of this double blind, randomized and controlled clinical study, was to evaluate the efficacy of potassium nitrate / sodium fluoride (KNO3 / KF) gel associated with LLLT (Low Level Light Therapy) on teeth that were exposed to 35% hydrogen peroxide during 3 weeks of bleaching treatment. Methods: 50 volunteers were evaluated through the split-mouth model, where the hemiarcates were randomized and later allocated in one of the experimental groups: G1 (negative control)- group with no desensitizing treatment, only bleached; G2 (positive control)- group treated with LLLT + placebo gel; G3- group treated with placebo laser application + 5% KNO3 / 2% KF gel; and G4- group treated with LLLT + 5% KNO3 / 2% KF gel.

Interventions

The group will receive in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 3 sessions, with a 7-day interval.

DRUGLow Level Laser Therapy

It will be used the infrared spectrum with wavelength of 808 nm in its active environment AsGaAl, in two points: cervical and apical region of the incisors, canines and premolars.

DRUG5% potassium nitrate / 2% sodium fluoride gel

5% potassium nitrate / 2% sodium fluoride gel will be applied for 10 minutes on the vestibular surface of all pre-bleached dental elements, following the manufacturer's protocol.

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
Universidade Federal do Para
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Absence of active carious lesions; * Never undergone bleaching therapy; * Good oral hygiene; * Do not present hypersensitivity; * Do not smoke; * Not being pregnant; * Presence of at least 28 teeth in oral cavity.

Exclusion criteria

* Presence of periodontal disease; * Presence of cracks or fractures; * Presence of restorations and prostheses; * Presence of gastroesophageal dysfunction; * Patients with severe internal dental dimming; * Presence of periodontal disease; * Presence of dentin exposure in anterior and/or posterior teeth.

Design outcomes

Primary

MeasureTime frameDescription
Change in Stimulated pain intensity in different assessment times (P15)15 days, with assessments in the 1st, 8th and 15th day of the treatmentThe stimulated pain intensity was self reported by the patients with a modified visual analog scale, from 0 to 3, where 0 means no pain, 1 is mild pain, 2 is moderate pain and 3 is severe pain. For all groups, the patients evaluated the stimulated pain intensity two times per session: before and after the treatment in the same day. Thus, in total each patient reported the pain intensity 6 times, two times in the first day (1st session), two times in the eighth day (2nd session) and two times in the fifteenth day (3rd session).

Secondary

MeasureTime frameDescription
Non-stimulated pain intensity measure, (P21)21 daysSelf reported non-stimulated pain intensity was assessed daily, during 21 days, through self-perception questionnaire, answered by the patients from the first tooth bleaching session until one week after the last session. The evaluation was performed by each patient, according to a modified visual analog scale, as follows: 0- no pain, 1 mild pain, 2 - moderate pain and 3 -severe pain

Countries

Brazil

Outcome results

None listed

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