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OpenTrials
Completed

NCT Number: NCT03514797

Combined Dental Bleaching Protocols and Time Required to Achieve Satisfactory Color

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.

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Key information

Conditions

Tooth Discoloration Stomatognathic Diseases Tooth Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universidade Federal de Sergipe

Aracaju, Sergipe, 49060100, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bleaching Agents

Drug

In-office tooth bleaching with 35% hydrogen peroxide in a single application of 45 minutes.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

André Luis Faria e Silva

Other

Registry information

Official study title

Effect of a Single Prior Session of In-office Dental Bleaching on Time Required to Obtain Satisfactory Tooth Color With At-home Bleaching

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 2, 2018
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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