Evaluation of the Effect of Fluoride and Laser Application on the Prevention of Sensitivity in Bleached Teeth

NCT03044171 | Completed Phase 1

• 1 other identifier: UFPara-001
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Stimulated pain intensity measure (P5)

  Self reported stimulated pain intensity assessed weekly, by modified visual scale, at baseline, after first, second, third and fourth in-office bleaching application. Each item is scored 0-3 (0 = no pain; 3 = pain as bad as can be).

  4 weeks

Secondary Outcomes (2)

• Non-stimulated pain intensity measure, (P28)

  28 days

• Recurrence of stimulated pain

  2 months

Study Arms (2)

G-FLUOR+LASER

EXPERIMENTAL

The corresponding hemiarcade received the application of Low Level Laser Therapy as a desensitizing treatment prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride after dental bleaching.

Device: Low Level Laser Therapy; Drug: 1.1% Sodium Fluoride; Drug: In-office dental bleaching

G-FLUOR

EXPERIMENTAL

The correspondent hemiarcade received only the positioning of the inactive laser tip (placebo), prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride as a desensitizing treatment after dental bleaching

Drug: 1.1% Sodium Fluoride; Drug: In-office dental bleaching

Interventions

Low Level Laser Therapy DEVICE

Laser therapy: it was used the infrared spectrum with wavelength of 808 nm in its active environment AsGaAl, in two points: cervical and central-medial region of the incisors, canines and premolars.

Also known as: LLLT

G-FLUOR+LASER

1.1% Sodium Fluoride DRUG

Fluoride therapy: 1.1% sodium fluoride 5000 ppm was applied for 5 minutes on the vestibular surface of all pre-bleached dental elements.

Also known as: Fluoride therapy

G-FLUOR; G-FLUOR+LASER

In-office dental bleaching DRUG

Both groups received the in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 4 sessions, with a 7-day interval.

Also known as: 35% hydrogen peroxide

G-FLUOR; G-FLUOR+LASER

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Absence of active carious lesions;
• Good oral hygiene;
• Do not present hypersensitivity;
• Do not smoke;
• Not being pregnant.

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.

Sponsors & Collaborators

• Universidade Federal do Para: lead

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

Low-Level Light Therapy; Sodium Fluoride; Hydrogen Peroxide

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Peroxides; Oxides; Anions; Ions; Electrolytes; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Organic Chemicals

Study Design

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

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 6, 2017
• Study Start: August 1, 2016
• Primary Completion: January 23, 2017
• Study Completion: February 23, 2017
• Last Updated: March 17, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share