Clinical Evaluation of Color-Adjusting Composite Resin Following In-Office Dental Bleaching

NCT06884813 | Recruiting

• 1 other identifier: 20250033
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

One challenge faced by dental professionals is that, unlike natural tooth structure, composite restorations do not lighten when exposed to bleaching agents. As a result, functional restorations may need replacement after bleaching to match the newly whitened teeth. However, replacing a composite restoration can lead to unnecessary removal of tooth structure, potentially weakening the tooth and increasing its susceptibility to further iatrogenic damage. This study will investigate the ability of Omnichroma restorations to shade-match tooth structure after bleaching. The null hypotheses will be:

1. 1.Single-shade RBC will not exhibit similar shade and optical behavior to conventional RBC across all anterior restorations following bleaching.
2. 2.Patient satisfaction regarding color blending between the restoration and tooth structure will not differ according to the type of material used.
3. 3.Dentist satisfaction regarding color blending between the restoration and tooth structure will not differ according to the type of material used.

Conditions

Composite Resins

Keywords

Single-shade composite; Bleaching; clinical trial; Shade matching

Outcome Measures

Primary Outcomes (3)

• Color measurements using digital spectrophotometer VITA Easyshade V.

  The colour measurements will be taken at first session for each tooth in specific points as follow: One reading from middle part of tooth Three readings at three points around the restoration and 1 mm away from its margins. To give a chance for tooth rehydration and final color optimization, a new reading will be obtained from the middle portion of the restoration after one week. The color difference (∆E00) between the tooth structure around the restoration and the restoration itself will be calculated. The color difference (∆E00) between the tooth and restoration will be compared between the control and test groups. The final ΔE00 value itself has no physical unit. It is just a numerical representation of color difference.

  One year

• Subjective or Patient satisfaction

  Patient satisfaction regarding color blending between the restoration and tooth surface will be recorded after one week using visual analogue scale (VAS). The scale is a horizontal line with 10 digits, where 0 (on the right) represents total dissatisfaction with color blending between the tooth and restoration, and 10 (on the left) indicates complete satisfaction. Patients will mark their satisfaction with the color matching and blending of the restoration on the VAS. Measurements will be categorized as follows: Poor: VAS values from 0 to 5 Good: VAS values from 5.1 to 10

  One year

• Objective or dentists satisfaction

  Photographs of the restored teeth will be taken under a standardized setup using a Canon 250D DSLR camera, a Sigma 105 mm macro lens, and a Meike MK-14EXT TTL macro ring flash. The images will be evaluated by two calibrated dentists who are blinded to the restoration material. Blending with the tooth surface will be assessed using VAS, with the assessors marking their evaluation on the scale. Measurements will be divided according following criteria: Poor: VAS values ranging from 0-5. Good :VAS values ranging from 5.1-10.

  One year

Study Arms (2)

Control group (Conventional RBC)

EXPERIMENTAL

In office bleaching for teeth restored using conventional multishade nanohybrid resin based composite (RBC).

Drug: Conventional nanohybrid multishade composite and hydrogen peroxide 40% in-Office Tooth Whitening System

Test group (RBC with CAP)

EXPERIMENTAL

In office bleaching for teeth restored using Omnichroma (single shade) composite with color adjustment postential (CAP).

Drug: Single shade nanohybrid composite and hydrogen peroxide 40% in-Office Tooth Whitening System

Interventions

Conventional nanohybrid multishade composite and hydrogen peroxide 40% in-Office Tooth Whitening System DRUG

Teeth restored with conventional multi shade nanohybrid Resin Based Composite (RBC) Filtek Z350Xt (3M ESPE, San Paul, MN, USA) subjected to bleaching using Opalescence Boost 40% In-Office Tooth Whitening System (Ultradent, Utah, USA)

Also known as: Conventional resin based composite (RBC) and Hydrogen perioxide 40%

Control group (Conventional RBC)

Single shade nanohybrid composite and hydrogen peroxide 40% in-Office Tooth Whitening System DRUG

Teeth restored with One-shade Resin Based Composite (Omnichroma, Tokuyama Dental, Tokio, Japan) subjected to bleaching using Opalescence Boost 40% In-Office Tooth Whitening System (Ultradent, Utah, USA)

Also known as: RBC with color adjustment potential (CAP) and Hydrogen perioxide 40%

Test group (RBC with CAP)

Eligibility Criteria

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

You may qualify if:

• Patients who are willing to come back for follow-up appointments.
• Patients who are willing to sign an informed consent form.
• Patients with well documented clinical records and have at least two anterior restorations (both Omnichroma and conventional multi-shade nanohybrid composite.)
• Patients aged 18 years or older.
• Patients with good oral hygiene
• Patients with vital teeth.
• Patients who are willing to have the restorations replaced later if necessary if there is a color mismatch after bleaching treatment.

You may not qualify if:

• Individuals with severe bruxism or periodontal disease.
• Patients with non-vital teeth restored with composite fillings.
• Patients with severe tooth discoloration.
• Patients with fluorosis or tetracycline staining.
• Heavy smokers.
• Pregnant or nursing women.
• Patients undergoing orthodontic treatment.
• Patients with enamel or dentin deformations.

Sponsors & Collaborators

• King Abdullah University Hospital: lead

Study Sites (1)

Jordan University of Science and Technology

Irbid, 21110, Jordan

RECRUITING

Related Publications (4)

• Villarroel M, Fahl N, De Sousa AM, De Oliveira OB Jr. Direct esthetic restorations based on translucency and opacity of composite resins. J Esthet Restor Dent. 2011 Apr;23(2):73-87. doi: 10.1111/j.1708-8240.2010.00392.x. Epub 2011 Feb 25.

  PMID: 21477031 BACKGROUND

• Hafez R, Ahmed D, Yousry M, El-Badrawy W, El-Mowafy O. Effect of in-office bleaching on color and surface roughness of composite restoratives. Eur J Dent. 2010 Apr;4(2):118-27.

  PMID: 20396441 BACKGROUND

• Forabosco E, Consolo U, Mazzitelli C, Kaleci S, Generali L, Checchi V. Effect of bleaching on the color match of single-shade resin composites. J Oral Sci. 2023 Oct 1;65(4):232-236. doi: 10.2334/josnusd.23-0159. Epub 2023 Aug 3.

  PMID: 37532526 BACKGROUND

• AlHabdan A, AlShamrani A, AlHumaidan R, AlFehaid A, Eisa S. Color Matching of Universal Shade Resin-Based Composite with Natural Teeth and Its Stability before and after In-Office Bleaching. Int J Biomater. 2022 Oct 26;2022:8420890. doi: 10.1155/2022/8420890. eCollection 2022.

  PMID: 36341131 BACKGROUND

MeSH Terms

Interventions

Hydrogen Peroxide; Erythrocyte Count

Intervention Hierarchy (Ancestors)

Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Organic Chemicals; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Zakereyya SM Albashaireh, Ph.D

CONTACT

0791015505; albashai@just.edu.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor) The patients who participated in the study and the assessor of the treatment outcome do not know the type of treatment procedure received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split mouth study design, patients will be assigned to two different treatment protocols.

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: March 10, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)