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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03044171
Other study ID # UFPara-001
Secondary ID
Status Completed
Phase Phase 1
First received January 30, 2017
Last updated March 16, 2017
Start date August 1, 2016
Est. completion date February 23, 2017

Study information

Verified date March 2017
Source Universidade Federal do Para
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

The objective of this double blind, randomized and controlled clinical study, was to evaluate the efficacy of 1.1% sodium fluoride associated with LLLT (Low Level Laser Therapy) on teeth that were exposed to 35% hydrogen peroxide during 4 weeks of bleaching treatment. Methods: 25 volunteers were evaluated through the split-mouth model, where the hemiarcates were ranzomized and later allocated in one of the experimental groups: G-FLUOR+LASER - constitutes the group treated with LLLT + 1.1% sodium fluoride; and G-FLUOR - constitutes the group treated with placebo + 1.1% sodium fluoride .


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date February 23, 2017
Est. primary completion date January 23, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- Absence of active carious lesions;

- Good oral hygiene;

- Do not present hypersensitivity;

- Do not smoke;

- Not being pregnant.

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Low Level Laser Therapy
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.
Drug:
1.1% Sodium Fluoride
Fluoride therapy: 1.1% sodium fluoride 5000 ppm was applied for 5 minutes on the vestibular surface of all pre-bleached dental elements.
In-office dental bleaching
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Para

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Non-stimulated pain intensity measure, (P28) Self reported non-stimulated pain intensity, assessed daily, by modified visual scale. Each item is scored 0-3 (0 = no pain; 3 = pain as bad as can be). 28 days
Secondary Recurrence of stimulated pain Return of stimulated pain after one month of the last intervention. Item is scored 0-3 (0 = no pain; 3 = pain as bad as can be). 2 months
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