RecruitingNot Applicable

Effectiveness of Dental Bleaching Using Different Designs of 3D-Printed and Conventional Customized Nightguards

Spain40 participantsStarted 2022-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

What they're measuring

Tooth color change (spectrophotometer; ΔE*ab)

Timeframe: 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)

Timeframe: 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).

Trial details

NCT IDNCT07464197

SponsorUniversitat Internacional de Catalunya

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

MARTA VALLES, DDS, PhD

+34619747903 mvalles@uic.es

View on ClinicalTrials.gov More Tooth Discoloration trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Tooth color change (spectrophotometer; ΔE*ab)

Timeframe: 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)

Timeframe: 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).