Gingival Irritation Due to Bleaching Tray Design in an At-home Bleaching Treatment

Gingival Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06371664
• Other study ID #: 2023/02
• Status: Completed
• Phase: Early Phase 1
• Start date: March 1, 2023
• Est. completion date: April 5, 2023

Study information

• Verified date: April 2024
• Source: University of Santiago de Compostela
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 5, 2023
• Est. primary completion date: April 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Inflammation
• Gingivitis
• Inflammation

Intervention

Drug:
• Conventional Tray (1 mm)
General examination with bite-wings. Dental prophylaxis (dental scaling and polishing with an abrasive paste). Alginate impressions of both arches. Creation of conventional individualized bleaching trays (trimmed 1 mm above the gingival margin) and a position-finder tray of both arches. Application of the bleaching gel in the bleaching trays during 6-8 hours
• Extended Tray (3 mm)
General examination with bite-wings. Dental prophylaxis (dental scaling and polishing with an abrasive paste). Alginate impressions of both arches. Creation of extended individualized bleaching trays (trimmed 3 mm above the gingival margin) and a position-finder tray of both arches. Application of the bleaching gel in the bleaching trays during 6-8 hours

Locations

Country	Name	City	State
Spain	School of Medicine and Dentistry	Santiago De Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
University of Santiago de Compostela

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective questionnaire of gingival irritation	Patients should answer daily a dental sensitivity questionnaire. They should mark a "0" if their gingival tissue appeared normal or a "1" If they observed GI, defined as the presence of a white or red layer on the gingiva.Patients who scored "0" during the treatment were classified as individuals without gingival irritation.	Daily, during 3 weeks
Primary	Objective clinical examination of gingival irritation	Clinicians examined visually and with a periodontal probe the gingival tissue.Patients were categorized according to Löe and Silness' gingival index as: G0 (normal gingiva); G1(mild inflammation: slight change in color, slight edema; no bleeding on probing); G2 (moderate inflammation: redness, edema and glazing; bleeding on probing); and G3 (severe inflammation: marked redness and edema; ulceration; tendency to spontaneous bleeding).Patients will a score of 0 during the treatment will be defined as patients with no gingival irritation. The individual highest recorded score will be the grade of gingival irritation.	Once a week, during 3 weeks
Secondary	Questionnaire of dental sensitivity	Patients should answer a dental sensitivity questionnaire. A a 5-point subjective numerical classification scale will be used (0=no sensitivity, 1=light, 2=mild, 3=considerable and 4=severe). Patients will a score of 0 during the treatment will be defined as patients with no sensitivity. The individual highest recorded score will be the grade of intensity for each patient.	Daily, during 3 weeks
Secondary	Shade evaluation with a dental spectrophotometer	The color will be measured with a dental spectrophotometer and the parameters L (Lightness), C (Chroma) and H (Hue) will be recorded. To determine the color change between visits the CIEDE2000 formula will be used.	Once a week, during 3 weeks