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

Dentin Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434782
• Other study ID #: UFPara-002
• Status: Completed
• Phase: Phase 1
• First received: January 16, 2018
• Last updated: February 13, 2018
• Start date: April 24, 2017
• Est. completion date: January 15, 2018

Study information

• Verified date: February 2018
• Source: Universidade Federal do Para
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 15, 2018
• Est. primary completion date: November 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Brennda Lucy Freitas de Paula	Belem	Para

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Para	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

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. Epub 2016 Mar 10. — 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. Epub 2011 Mar 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Non-stimulated pain intensity measure, (P21)	Self 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	21 days