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

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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Inflammation
• Intervention / Treatment: Drug: Conventional Tray (1 mm); Drug: Extended Tray (3 mm)

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).

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Spain
  • A Coruña
    • Santiago De Compostela, A Coruña, Spain, 15705
      • School of Medicine and Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Conventional Tray (1 mm); Patients put in their individualized 1 mm bleaching trays the bleaching treatment every day during three weeks.	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
Experimental: Extended Tray (3 mm); Patients put in their individualized 3 mm bleaching trays the bleaching treatment every day during three weeks.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Santiago de Compostela

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): April 5, 2023
• Study Completion (Actual): April 5, 2023

Study Registration Dates

• First Submitted: April 14, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Tooth bleaching; Vital Bleaching; At-Home bleaching; Gingival Irritation; Bleaching tray
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Inflammation; Gingivitis
• Other Study ID Numbers: 2023/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes