Skip to content

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

Effect of bioactive glass on efficacy and postoperative sensitivity associated with in-Office tooth bleaching using 35% hydrogen peroxide: a randomized controlled clinical trial in healthy adults aged 18 to 40 years.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000794303
Enrollment
34
Registered
2026-07-02
Start date
2025-09-09
Completion date
2026-04-25
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study tests whether BioMin F reduces tooth sensitivity after in-office bleaching with 35% hydrogen peroxide.

Interventions

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

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.

Sponsors

Damascus university
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1.The patient's age must be at least 18 years. 2.Six upper 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.

Exclusion criteria

1.The patient has not undergone any previous teeth whitening procedures. 2.A history of chronic therapeutic drug use. 3.The presence of orthodontic devices. 4.Periodontal diseases or active carious lesions. 5.Pregnancy or breastfeeding. 6.Severe intrinsic tooth discoloration. 7.Sensitivity to whitening materials. 8.Smoking. 9.Patients with oral manifestations that may cause sensitivity (such as recession, fissures, or exposed dentin).

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026