Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05612516 |
| Other study ID # |
CU-2-2022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 10, 2024 |
| Est. completion date |
May 8, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of the study is to clinically assess the peroxide levels in saliva during bleaching
with 9.5% hydrogen peroxide using a tray with or without reservoir.
Description:
Statement of the Problem There is more concern about the possible adverse effect of bleaching
agent, patients report gastrointestinal mucosal irritation e.g. a burning palate, throat and
minor upsets in the stomach and intestine. Some adverse effects of hydrogen peroxide as a
dental bleaching agent include dentin sensitivity and/or gingival irritation led by unstable
and reactive H+ free radicals and low pH from prolonged use. Peroxide is a highly reactive
substance which can damage oral soft tissues and hard tissues when present in high
concentrations and with exposures of prolonged duration. (Alqahtani, 2014). Several
researches have focused on the problem of gel ingestion and potential peroxide release in
saliva (Dahl et al, 2003; Watt et al, 2004; Bernardon et al, 2010; Goldberg et al, 2010).
Rationale
Reservoirs are modifications in the tray molds to increase the amount of bleaching material
carried by the bleaching tray, seeking greater bleaching efficacy. The use of reservoirs in
the bleaching trays was initially seen as positive, since higher accumulation of material
could provide the patient with greater treatment efficacy. Martini et al, 2020 stated that
there is no significant difference between groups whitened with and without reservoirs for
gingival irritation or tooth sensitivity. Most authors and bleaching gel manufacturers
recommend the use of reservoirs to increase the amount of product available for bleaching and
to allow for complete seating of the bleaching tray, although that the reservoirs decrease
tray retention and increase lab fabrication time and cost (Javaheri et al, 2000). The
presence of reservoirs decreases the retention of the tray, allowing more room for the gel
but also reducing the adaptation of the tray. That may cause more leakage of the material,
which may lead to more peroxide level in saliva. (Haywood et al, 1992).
A major concern for clinicians was the potential toxicological effect of hydrogen peroxide
contacting soft tissues. A safe hydrogen peroxide exposure level (no observed effect level)
was determined with catalase-deficient mice, reporting a maximum dose of 26 mg/kg/d. This
corresponds to the dose level in humans, considering the conventional uncertainty factor of
100-fold, of 0.26 mg/kg/d (IGHRC, 2003; Hannig et al, 2005; Li et al, 2011). The safety of
hydrogen peroxide products used for at home bleaching regarding peroxide release in saliva
has not been fully proven.
