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

NCT03434782 | Completed Phase 1

• 1 other identifier: UFPara-002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change in Stimulated pain intensity in different assessment times (P15)

  The 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).

  15 days, with assessments in the 1st, 8th and 15th day of the treatment

Secondary Outcomes (1)

• Non-stimulated pain intensity measure, (P21)

  21 days

Study Arms (4)

G1- Negative Control

EXPERIMENTAL

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).

Drug: In-office dental bleaching

G2- LASER (Positive Control)

EXPERIMENTAL

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

Drug: In-office dental bleaching; Drug: Low Level Laser Therapy

G3- KNO3 (Positive Control)

EXPERIMENTAL

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).

Drug: In-office dental bleaching; Drug: 5% potassium nitrate / 2% sodium fluoride gel

G4- KNO3 + LASER

EXPERIMENTAL

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

Drug: In-office dental bleaching; Drug: Low Level Laser Therapy; Drug: 5% potassium nitrate / 2% sodium fluoride gel

Interventions

In-office dental bleaching 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.

Also known as: 35% hydrogen peroxide

G1- Negative Control; G2- LASER (Positive Control); G3- KNO3 (Positive Control); G4- KNO3 + LASER

Low Level Laser Therapy 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.

Also known as: LLLT

G2- LASER (Positive Control); G4- KNO3 + LASER

5% potassium nitrate / 2% sodium fluoride gel 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.

Also known as: desensitizing therapy

G3- KNO3 (Positive Control); G4- KNO3 + LASER

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Para: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Brennda Lucy Freitas de Paula

Belém, Pará, 66055-280, Brazil

Location

Related Publications (2)

• 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.

  PMID: 21488723 BACKGROUND

• 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.

  PMID: 26964798 RESULT

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Hydrogen Peroxide; Low-Level Light Therapy; potassium nitrate

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Organic Chemicals; Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 15, 2018
• Study Start: April 24, 2017
• Primary Completion: November 24, 2017
• Study Completion: January 15, 2018
• Last Updated: February 15, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)