Clinical trial NCT06371664: Gingival Irritation Due to Bleaching Tray Design in an At-home Bleaching Treatment
Official title: Does the Use of a 3-mm Extended Tray During an At-home Bleaching Treatment Increases Gingival Irritation Associated With This Procedure in an Adult Patient: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gingival Inflammation
Keywords: Tooth bleaching
Vital Bleaching
At-Home bleaching
Gingival Irritation
Bleaching tray
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, triple-blind clinical trial
Primary purpose: PREVENTION

Brief summary: The primary aim of this study is to assess whether the design of the bleaching tray used in at-home bleaching treatment is directly correlated with the risk of gingival irritation. Additionally, it aims to investigate whether the design influences the likelihood of dental sensitivity and its impact on the degree of tooth whitening.

Detailed description: Visit 1: Study information and delivery of informed consent. Recording of the patient's medical history, general examination, and prophylaxis. Alginate impressions will be taken of the upper and lower arches for all patients who meet the inclusion criteria. The impressions will be poured into plaster, and individualized bleaching trays will be made for each patient according to the predetermined assignment ( 1mm extended or 3 mm extended bleaching tray). A positioning guide tray will be fabricated for color measurement.

Visit 2: Initial color measurement with a spectrophotometer and the positioning guide. Each patient will receive their individualized trays. Additionally, they will be given 3 syringes of bleaching agent (Opalescence 16%, Ultradent Products). Each patient will be provided with an instruction sheet and recording sheets to fill out daily during the 3-week study period. They will record if they had gingival irritation and the degree of dental sensitivity.

Visit 3: First-week bleaching review. Data collection (gingival irritation + color + sensitivity).

Visit 4: Second-week bleaching review. Data collection (gingival irritation + color + sensitivity).

Visit 5: Third-week bleaching review and end of the study. Data collection (gingival irritation + color + sensitivity).

Eligibility criteria: Inclusion Criteria:

* No oral or systemic pathology
* Periodontally healthy
* No cavities
* Tooth shade of the upper and lower canines A2 or darker

Exclusion Criteria:

* Adhesive restorations or prostheses in the anterior region
* Enamel or dentin alterations
* Smoking
* Pregnant women
* Undergone prior bleaching treatment

Primary outcomes:
measure: Subjective questionnaire of gingival irritation
timeFrame: Daily, during 3 weeks
measure: Objective clinical examination of gingival irritation
timeFrame: Once a week, during 3 weeks
Secondary outcomes:
measure: Questionnaire of dental sensitivity
timeFrame: Daily, during 3 weeks
measure: Shade evaluation with a dental spectrophotometer
timeFrame: Once a week, during 3 weeks
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: School of Medicine and Dentistry
state: A Coruña
Study officials:
References: