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Evaluating the effect of age on effectiveness, gingival irritation, and sensitivity following at home bleaching.

Evaluating the effect of age on effectiveness, gingival irritation, and sensitivity following at home bleaching using 10% carbamide peroxide 2 hours a day for 3 weeks.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000547640
Enrollment
30
Registered
2023-05-22
Start date
2023-10-01
Completion date
2023-12-03
Last updated
2024-05-06

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

Conditions

None listed

Brief summary

The mechanism of bleaching using oxidizing agents have been thoroughly disscussed in the literature, and it has been suggested that hydrogen peroxide particles can difusse through dentin tubules to reach and break the rings of the pigmenting molecules, converting them to carbon chanis which are assumed to be lighter in color. This mechanism renders the tooth whiter, but could also cause tooth sensitivity due to the irritation of the pulp by hydrogen peroxide paricles. In addition, gingival tissue might get damaged if came in contact with the whitening solution. It has been also stated that the diameter of dentin tubles decreases with age, and the blood supply of the gingival tissue decreases as well. These changes may hamper the progression of hydrogen peroxide paricles through dentin and into the pulp tissue and render the gingval tissue more susceptible to inflammation. Based on these statements, we made the hypothesis that the effectivness and post sensitivity of tooth bleaching will decrease with age and gingival irritation during tooth bleaching will increase. So this study will be evaluating the effect of age difference on the whitening efficacy and side effects of at home bleaching using carbamide peroxide. Patients will be assigned to one of three groups depending on thier age, group 1 (14-18 years old), group 2 (20-40 years old), group 3 (5o years old or higher), and a bleaching procedure using carbamide peroxide 10% will be applied to all patients 2 hours a day for 3 weeks. During the procedure, tooth shade, sensitivity, and gingival irritation will be recorded weekly. Tooth sahde will be measured using a spectrophotometer device (Vita Easy sahde), tooth sensitivity will be measured using a daily visual analog scale (VAS), and for gingival irritation, patients will fill a daily survey indicating if they felt any discomfort or irritation in thier gingiva, and gingival index will be recorded for the upper arch every week during the procedure.

Interventions

At home tooth bleaching with 10% carbamide peroxide applied for 2 hours a day for 3 weeks, the patients were instructed to apply the material at the same time every day The patients will be divided to three groups depending on their age as follows: 14-18 years old age group, 20-40 years old age group, 50 years old or higher group. The carbamide peroxide will be applied to the facial surface of the upper six anterior teeth via individual trays made with 1 mm thick ethylene-vinyl acetate.

Sponsors

Damascus universtiy
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
14 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Healthy patients with at least 6 maxillary anterior sound teeth. The canine must have a shade of A2 or darker according to the vita classic shade guide.

Exclusion criteria

Patients with the 6 maxillary anterior teeth having active carious lesions, or crowns, or large restorations. Smoking or heavy drinking patients.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026