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Combined Dental Bleaching Protocols and Time Required to Achieve Satisfactory Color

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ClinicalTrials.gov Identifier: NCT03514797
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
André Luis Faria e Silva, Universidade Federal de Sergipe

Brief Summary:
This parallel, randomized, and controlled clinical trial will assess the effect of a single prior session of in-office dental bleaching on time required to achieve satisfactory tooth color with at-home bleaching. Participants enrolled will randomly allocated to receive or not a single session of dental bleaching with 35% hydrogen peroxide applied for 45 min. Following, all participants will use customized trays filled with 10% carbamide peroxide for 1h per day until obtain satisfactory results. The primary outcome will be the number of days necessary to obtain satisfactory tooth color. Furthermore, tooth sensitivity and color changes measured with spectrophotometer will be assessed.

Condition or disease Intervention/treatment Phase
Tooth Discoloration Drug: Bleaching Agents Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a Single Prior Session of In-office Dental Bleaching on Time Required to Obtain Satisfactory Tooth Color With At-home Bleaching
Actual Study Start Date : April 13, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combined technique
A single session of in-office tooth bleaching will be performed with 35% hydrogen peroxide for 45 minutes. Following, the teeth will be further bleached with customized trays filled with 10% carbamide peroxide and used for 1h per day.
Drug: Bleaching Agents
In-office tooth bleaching with 35% hydrogen peroxide in a single application of 45 minutes.

Drug: Bleaching Agents
At-home tooth bleaching with 10% carbamide peroxide for 1 hour per day.

Active Comparator: At-home bleaching
The teeth will be bleached only with customized trays filled with 10% carbamide peroxide and used for 1h per day.
Drug: Bleaching Agents
At-home tooth bleaching with 10% carbamide peroxide for 1 hour per day.




Primary Outcome Measures :
  1. Time to tooth color satisfaction [ Time Frame: up to 1 month after beginning the tooth bleaching procedures ]
    Time in days performing at-home bleaching necessary to participant reports that is satisfied with the tooth color obtained


Secondary Outcome Measures :
  1. Color change [ Time Frame: up to 1 month after beginning the tooth bleaching procedures ]
    Values of delta E measured with a spectrophotometer from color at baseline

  2. Tooth sensitivity [ Time Frame: 1, 2, 3, and 4 week after beginning the tooth bleaching procedures ]
    Maximum level of tooth sensitivity reported by participants using an analogue visual scale. The distance between the patient`s marking and the no pain border was recorded in cm.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general and oral health;
  • Upper canines darker than the tab 2.5M2 at VITA Bleachedguide 3D-MASTER® (Vita-Zahnfabrik, Bad Sackingen, Germany) scale.

Exclusion Criteria:

  • Presence of non-treated caries or periodontal disease;
  • Prior tooth hypersensitivity;
  • Presence of gingival recession;
  • Teeth with cracked enamel or any hypoplasia;
  • Patients using oral removable or fixed orthodontic appliances;
  • Patients were pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514797


Locations
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Brazil
Universidade Federal de Sergipe
Aracaju, SE, Brazil, 49060100
Sponsors and Collaborators
André Luis Faria e Silva

Publications:
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Responsible Party: André Luis Faria e Silva, Principal Investigator, Universidade Federal de Sergipe
ClinicalTrials.gov Identifier: NCT03514797     History of Changes
Other Study ID Numbers: Combined bleaching
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by André Luis Faria e Silva, Universidade Federal de Sergipe:
Tooth bleaching
Hydrogen peroxide
Carbamide peroxide
Tooth Bleaching Agents
Additional relevant MeSH terms:
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Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases
Hydrogen Peroxide
Carbamide Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents