Effect of BioMin F on tooth sensitivity after in-office bleaching

Authors
Category Primary study
Registry of TrialsAustralian New Zealand Clinical Trials Registry
Year 2026
INTERVENTION: All participants will undergo professional cleaning of the study teeth prior to whitening. The tooth surfaces will be cleaned using a non‐abrasive, fluoride‐free whitening powder and a brush attached to a microbrush to remove plaque and surface deposits. Participants in the intervention group will use BioMin F toothpaste, and participants in the control group will use a placebo paste, applied into customised trays at home. A thin, even layer of the assigned paste will be placed inside the tray in an amount sufficient to cover the study teeth without overflow. The tray will be worn once daily for 30 minutes for one week before the first in‐office whitening session. Following this pre‐treatment period, in‐office whitening will be performed using 35% hydrogen peroxide gel applied to the study teeth (from the right first premolar to the left first premolar) for 40 minutes. Before application of the whitening gel, gingival isolation will be performed using a gingival barrier gel. All in‐office whitening procedures will be performed by the treating dentist in the clinical setting. There will be two in‐office whitening sessions separated by one week. After the first whitening session, the assigned paste (BioMin F or placebo) will be reapplied using the customised tray once daily for 30 minutes for another week, i.e. during the interval between the two whitening sessions. The tray‐based paste application will be self‐administered by the participants at home. Adherence will be monitored by asking participants to submit photographs showing the material placed inside the tray and the tray in situ during use. These photographs will be reviewed by the research team to confirm compliance with the study protocol. CONDITION: Oral and Gastrointestinal ‐ Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon Teeth discoloration ; ; Teeth discoloration PRIMARY OUTCOME: Color change using color shade guide.[color shade guide Primary outcomes will be assessed at the following timepoints:; Baseline (before first bleaching session), 1 week post‐first bleaching (before second session), 1 week post‐second bleaching session (primary timepoint), 4 weeks post‐second bleaching, 3 months post‐baseline, and 6 months post‐baseline.] Color change using digital spectrophotometer[digital spectrophotometer Primary outcomes will be assessed at the following timepoints:; Baseline (before first bleaching session), 1 week post‐first bleaching (before second session), 1 week post‐second bleaching session (primary timepoint), 4 weeks post‐second bleaching, 3 months post‐baseline, and 6 months post‐baseline.] SECONDARY OUTCOME: Teeth sensitivity using visual analog scale[visual analog scale Tooth sensitivity will be assessed at the following timepoints relative to the bleaching intervention: ; Before the first bleaching session (baseline). ; 2 hours after the first bleaching session. ; 1 day after the first bleaching session. ; 2 days after the first bleaching session. ; 2 hours after the second bleaching session ; 1 day after the second bleaching session ; 2 days after the second bleaching session ; 1 month post‐baseline (1 month after the second bleaching session) ; 3 months post‐baseline (3 months after the second bleaching session).] INCLUSION CRITERIA: 1.The patient's age must be at least 18 years. 2.Si Xupper anterior teeth free of caries or restorations on the buccal surfaces. 3.The tooth color should not be less than A2 on the Classical scale in the Compact Vita 3 shade guide. 4.No dental sensitivity or use of anti‐sensitivity materials or toothpastes for sensitive teeth in the last three months. 5.The patient should be in good overall health.
Epistemonikos ID: 52740b9a33cda73ded1c271f96089c29c4ce275c
First added on: Aug 10, 2026