EFFECTIVENESS OF A NEW BLEACHING AGENT AFTER SINGLE USE IN COMPARISON TO A PLACEBO – A CLINICAL SHORT-TERM STUDY

Not Applicable

• Conditions: extrinsic tooth discoloration; K03.6; Deposits [accretions] on teeth

• Registration Number: DRKS00007636
• Lead Sponsor: Sylphar NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-11-18
• Study Start: 2015-01-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 12 natural, frontal teeth
• tooth color darker than A2 of the Vita-Shade-Guide

Exclusion Criteria

• acute disease
• alcoholism
• smoker
• allergy
• pregnant/nursing
• acute ginivitis, gingivostomatitis, reduced immunesystem caused by disease (eg HIV)
• orthodontic
• hypersensitive teeth or exposed dentin tubuli
• pathological or defect enamel structure
• extensive fillings or crowns on frontal teeth
• bleaching

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shade improvement of the examined teeth directly after single use treatment with the OTC bleaching agent in comparison to the placebo with the Vita-Shade-Guide.

Secondary Outcome Measures

Name	Time	Method
Shade improvement of the examined teeth 24 hours after the treatment in comparison to the placebo with a Vita-Shade-Guide. No tooth sensitivities or muscosairritations directly or after 24 hour after treatment. The sensibilities are assessed using coolant spray and physiological feedback of the subject. Hypersensibilities after the treatment are assessed in comparison to baseline measurements. The mucosa is visually clinical examined by the investigator and irritations and/or ulcerations protocolled. The good acceptance is assessed by an individual (PI) made questionaire subject questionaire, filled out by the subjects on the last visit.