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

NCT06371664 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 2023/02
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Inflammation

Keywords

Tooth bleaching; Vital Bleaching; At-Home bleaching; Gingival Irritation; Bleaching tray

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Questionnaire of dental sensitivity

  Daily, during 3 weeks

• Shade evaluation with a dental spectrophotometer

  Once a week, during 3 weeks

Study Arms (2)

Conventional Tray (1 mm)

PLACEBO COMPARATOR

Patients put in their individualized 1 mm bleaching trays the bleaching treatment every day during three weeks.

Drug: Conventional Tray (1 mm)

Extended Tray (3 mm)

EXPERIMENTAL

Patients put in their individualized 3 mm bleaching trays the bleaching treatment every day during three weeks.

Drug: Extended Tray (3 mm)

Interventions

Conventional Tray (1 mm) DRUG

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

Conventional Tray (1 mm)

Extended Tray (3 mm) DRUG

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

Extended Tray (3 mm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

School of Medicine and Dentistry

Santiago de Compostela, A Coruña, 15705, Spain

Location

Related Publications (1)

• Pereira-Lores P, Martin-Gonzalez J, Gancedo-Gancedo T, Alonso de la Pena V, Alvarez-Novoa P, Varela-Aneiros I, Abella-Sans F, Martin-Biedma B, Castelo-Baz P. Does the use of a 3-mm extended tray during an at-home bleaching treatment increase gingival irritation? A randomized clinical trial. J Prosthet Dent. 2025 May;133(5):1277-1283. doi: 10.1016/j.prosdent.2024.09.029. Epub 2024 Nov 18.

  PMID: 39562219 DERIVED

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, triple-blind clinical trial

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 17, 2024
• Study Start: March 1, 2023
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)