NCT07464197

Brief Summary

This randomized, double-blind, split-mouth clinical trial evaluates the effectiveness of at-home dental bleaching using customized nightguards fabricated by digital (3D-printed CAD-CAM) and conventional methods, with and without reservoirs. Adult participants with good general and oral health and a baseline tooth shade of A2 or darker undergo bleaching with 10% carbamide peroxide. Outcomes include tooth color change (subjective and spectrophotometric measures), tooth sensitivity, gingival irritation, patient comfort, and patient satisfaction over time.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
May 2022Jul 2026

Study Start

First participant enrolled

May 1, 2022

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

February 25, 2026

Last Update Submit

March 11, 2026

Conditions

Tooth DiscolorationTooth Staining

Keywords

dental bleachingcustom tray3D-printed trayCAD-CAMCarbamide peroxideNightguard vital bleachingTooth sensitivityGingival irritationSpectrophotometerSplit-mouth trialtooth whitening

Outcome Measures

Primary Outcomes (2)

  • Tooth color change (spectrophotometer; ΔE*ab)

    Tooth color measured with a spectrophotometer (VITA Easyshade) using CIE L\*, a\*, b\* values. Color change will be calculated as ΔE\*ab relative to baseline (T0). Measurements are standardized using a customized positioner. Bleaching was performed from T0 through T5. No bleaching gel was applied between T5 and T6; T6 assessed post-treatment stability and adverse effects.

    T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).

  • Tooth shade change (VITA Bleachedguide 3D-MASTER; shade guide units)

    Tooth shade assessed visually using the VITA Bleachedguide 3D-MASTER. Shade guide scores will be converted to numeric values and reported as change from baseline (T0) at each time point. Bleaching was performed from T0 through T5. No bleaching gel was applied between T5 and T6; T6 assessed post-treatment stability and adverse effects.

    T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).

Secondary Outcomes (6)

  • Tooth sensitivity (Numeric Rating Scale, 0-4)

    T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).

  • Tooth sensitivity (Visual Analog Scale, 0-10)

    T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).

  • Gingival irritation presence (NRS, 0-2)

    T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).

  • Gingival irritation severity (NRS, 0-2)

    T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).

  • Patient comfort (VAS, 0-10)

    T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).

  • +1 more secondary outcomes

Study Arms (4)

Digital tray with reservoir

EXPERIMENTAL

Customized digital (3D-printed CAD-CAM) bleaching tray with reservoir design for at-home bleaching with 10% carbamide peroxide.

Procedure: Customized bleaching tray fabricationProcedure: Reservoir tray designDrug: Carbamide peroxide 10%

Digital tray without reservoir

EXPERIMENTAL

Customized digital (3D-printed CAD-CAM) bleaching tray without reservoir design for at-home bleaching with 10% carbamide peroxide.

Procedure: Customized bleaching tray fabricationProcedure: Reservoir tray designDrug: Carbamide peroxide 10%

Conventional tray with reservoir

EXPERIMENTAL

Customized conventional vacuum-formed bleaching tray with reservoir design for at-home bleaching with 10% carbamide peroxide.

Procedure: Customized bleaching tray fabricationProcedure: Reservoir tray designDrug: Carbamide peroxide 10%

Conventional tray without reservoir

EXPERIMENTAL

Customized conventional vacuum-formed bleaching tray without reservoir design for at-home bleaching with 10% carbamide peroxide.

Procedure: Customized bleaching tray fabricationProcedure: Reservoir tray designDrug: Carbamide peroxide 10%

Interventions

Customized bleaching tray fabricationPROCEDURE

Customized bleaching trays were fabricated using either a conventional vacuum-forming technique or a digital CAD-CAM 3D-printing technique, according to randomized allocation within a split-mouth design.

Also known as: Conventional vacuum-formed tray fabrication, Digital 3D-printed CAD-CAM tray fabrication
Conventional tray with reservoirConventional tray without reservoirDigital tray with reservoirDigital tray without reservoir
Reservoir tray designPROCEDURE

Tray designs were prepared either with a reservoir or without a reservoir, according to randomized allocation across hemiarches within the split-mouth design.

Also known as: With reservoir, Without reservoir
Conventional tray with reservoirConventional tray without reservoirDigital tray with reservoirDigital tray without reservoir
Carbamide peroxide 10%DRUG

At-home bleaching gel containing 10% carbamide peroxide applied in customized trays according to the study protocol

Also known as: 10% carbamide peroxide bleaching gel
Conventional tray with reservoirConventional tray without reservoirDigital tray with reservoirDigital tray without reservoir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older
  • Good general and oral health
  • No current medical treatment (self-reported)
  • No need for surgical, endodontic, periodontal, or restorative dental treatment
  • At least six upper and six lower anterior teeth free of caries and restorations
  • Maxillary central incisors with baseline shade A2 or darker
  • Willingness to follow the study protocol and use the study-provided oral hygiene products/instructions

You may not qualify if:

  • Previous tooth bleaching treatment
  • Orthodontic appliances or prostheses that interfere with treatment
  • Severe intrinsic discoloration (e.g., tetracycline staining, fluorosis, or endodontically treated teeth with discoloration)
  • Pregnancy or lactation
  • Bruxism
  • Gingival recession, dentin exposure, visible enamel cracks, or other conditions associated with increased sensitivity
  • Use of anti-inflammatory or analgesic medication during the study period (according to protocol)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Universitària d'Odontologia UIC Barcelona

Sant Cugat del Vallès, BARCELONA, 08195, Spain

RECRUITING

MeSH Terms

Conditions

Tooth DiscolorationDentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • MARTA VALLES, DDS, PhD

    Universitat Internacional de Catalunya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MARTA VALLES, DDS, PhD

CONTACT

+34619747903mvalles@uic.es

LISSETHE PEÑATE, DDS, PhD

CONTACT

+34 679 81 52 13lissethe@uic.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and clinical outcome evaluators were unaware of group assignments. Data analysis was performed by a separate researcher who was not involved in treatment administration or outcome assessment. Due to the nature of tray fabrication and delivery, personnel involved in tray preparation may not have been blinded.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: This is a randomized split-mouth clinical trial. Each participant receives both tray fabrication methods (conventional vacuum-formed and digital 3D-printed CAD-CAM) in different arches, and both tray designs (with and without reservoirs) distributed across hemiarches according to randomized allocation. Therefore, within-participant comparisons are performed for tray fabrication method and reservoir presence.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, phD

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 11, 2026

Study Start

May 1, 2022

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the dataset contains potentially identifiable clinical information from a small sample treated at a single center, and no data-sharing plan was included in the original participant consent.

Locations

ES(1)