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

NCT ID: NCT03434782

Last Updated: 2018-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-24

Study Completion Date

2018-01-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Dentin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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G1- Negative Control

Group with no desensitizing treatment. Prior to bleaching therapy, a water-soluble placebo gel, with non-active agent will be applied to dental vestibular surfaces. After bleaching therapy, the LASER tip will be positioned in two points (apical and cervical), without light emission (placebo).

Group Type EXPERIMENTAL

In-office dental bleaching

Intervention Type DRUG

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.

G2- LASER (Positive Control)

Group treated with placebo gel before bleaching and with LLLT after in-office bleaching.

Group Type EXPERIMENTAL

In-office dental bleaching

Intervention Type DRUG

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.

Low Level Laser Therapy

Intervention Type DRUG

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.

G3- KNO3 (Positive Control)

Group treated with desensitizing gel before bleaching and after in-office bleaching, the LASER tip will be positioned in two points (apical and cervical), without light emission (placebo).

Group Type EXPERIMENTAL

In-office dental bleaching

Intervention Type DRUG

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.

5% potassium nitrate / 2% sodium fluoride gel

Intervention Type DRUG

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.

G4- KNO3 + LASER

Group treated with desensitizing gel before bleaching and with LLLT after in-office bleaching.

Group Type EXPERIMENTAL

In-office dental bleaching

Intervention Type DRUG

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.

Low Level Laser Therapy

Intervention Type DRUG

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.

5% potassium nitrate / 2% sodium fluoride gel

Intervention Type DRUG

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.

Interventions

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In-office dental bleaching

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.

Intervention Type DRUG

Low 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.

Intervention Type DRUG

5% 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.

Intervention Type DRUG

Other Intervention Names

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35% hydrogen peroxide LLLT desensitizing therapy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Universidade Federal do Para

OTHER

Sponsor Role lead

Responsible Party

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Cecy Martins Silva

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brennda Lucy Freitas de Paula

Belém, Pará, Brazil

Site Status

Countries

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Brazil

References

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Reis A, Dalanhol AP, Cunha TS, Kossatz S, Loguercio AD. Assessment of tooth sensitivity using a desensitizer before light-activated bleaching. Oper Dent. 2011 Jan-Feb;36(1):12-7. doi: 10.2341/10-148-CR. Epub 2011 Mar 24.

Reference Type BACKGROUND
PMID: 21488723 (View on PubMed)

Moosavi H, Arjmand N, Ahrari F, Zakeri M, Maleknejad F. Effect of low-level laser therapy on tooth sensitivity induced by in-office bleaching. Lasers Med Sci. 2016 May;31(4):713-9. doi: 10.1007/s10103-016-1913-z. Epub 2016 Mar 10.

Reference Type RESULT
PMID: 26964798 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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UFPara-002

Identifier Type: -

Identifier Source: org_study_id

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