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. 2018 Dec 18;2018(12):CD006202. doi: 10.1002/14651858.CD006202.pub2

Reinhardt 1993.

Methods Title: a clinical study of nightguard vital bleaching
Trial design: double‐blinded, randomised controlled clinical trial
Location: University of Iowa, USA
Language: English
Number of centres: 1
Recruitment period: not reported
Funding source: Dentmart and Omnii International
Participants Participants: not reported
Total number: 56
Inclusion criteria: not reported
Exclusion criteria: patients with significant periodontal disease; internal tooth staining
Number randomised: 56
Method of randomisation: not reported
Method of allocation concealment: mentioned, but method not reported
Method of blinding: not reported
Number evaluated: 56
Interventions Total number of intervention groups: 4 (3 different tray‐based brands versus placebo). Intervention with 2 different application regimens for each
Proxigei
  • Overnight n = 9

  • 3 hours n = 8


White & Brite
  • Overnight n = 6

  • 3 hours n = 9


Rembrandt Lighten
  • Overnight n = 8

  • 3 hours n = 8


Control
  • Overnight n = 4

  • 3 hours n = 4


Duration of treatment: 3 weeks
Outcomes Improvement in shade: Vita shade guide: lightest to darkest using Munsell Value
Gingival Index: 0 = no inflammation; I = inflammation, but no bleeding; 2 = bleeding on probing; and 3 = spontaneous bleeding
Plaque Index: 0 = no plaque; 1= plaque detectable; 2 = plaque from interproximal surface to interproximal surface; 3 = plaque on more than half of tooth
Notes Sample size calculation: not reported
Adverse effects: sensitivity
Health‐related quality of life: not reported
Key conclusions of the study authors: "The overnight (1 application) method produced tooth‐lightening resulted at least equivalent to those of the multiple application (3‐application, 3‐hour) method. When Proxigei or Rembrandt was used, overnight and 3‐hour replenishment produced similar results. The use of White & Brite overnight also produced results similar to those of Rembrandt and Proxigei. The least effective treatment was White & Brite used with 3‐hour replenishment"
Correspondence required: yes: the percentage of the active ingredient used in the trial is not clear. Authors contacted
Contact: John W Reinhardt, Department of Operative Dentistry, University of Iowa College of Dentistry, Iowa City 52242, USA