Effect of Aging on Micro-tensile Bond Strength and Color Stability of Self-adhesive Resin Composite

Tooth Decay Clinical Trial

Official title:

Evaluation of Micro -Tensile Bond Strength to Dentin and Color Stability of a New Self Adhesive Bulk-fill Resin Composite Restorative Material After Aging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06463574
• Other study ID #: self-adhesive resin composite
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Minia University
• Contact: Nourhan Samir Soliman, Assisstant Lecturer
• Phone: 1066175951
• Email: nourhan.samir[@]pua.edu.eh
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the micro-tensile bond strength of a newly self-adhesive resinous restorative material to dentin with and without application of universal bonding system (in-vitro) and to examine it's clinical performance by evaluation of it's color stability and marginal discoloration through a randomized clinical trial (in-vivo).

Description:

For color stability and marginal discoloration test, twenty class I cavities were prepared in the molar teeth of twenty different patients and then were randomly divided into two groups of ten patients each, where half of the molars was restored with Surefil one self-adhesive bulk-fill composite and the other half with Filtek One bulk-fill composite. A VITA Easyshade spectrophotometer was used to measure the baseline color of the restoration and at the margin after 24 hours and degree of color change and marginal discoloration after 3 months and 6 months of composite placement and then degree of color change (ΔE) was determined using the CIE L*a*b* system. All discolored restored molar teeth of both composite types were polished using a series of different thickness of Sof-Lex aluminum oxide discs (coarse, medium, fine), then the degree of color change of the restoration and at the margin (ΔE) was determined and was then compared to the baseline color measurements.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients with class I lesion in their maxillary or mandibular molars with a maximum of approximately 2 mm final cavity depth.

• Patients with teeth shade A2 according to Vitapan classical shade guide.

• Patients with an acceptable oral hygiene level.

• Patients keen to regularly attend the follow up visits.

Exclusion Criteria:

• Patients with heavy bruxism or traumatic occlusion.

• Patients with poor oral hygiene or active periodontal disease.

• Patients with exposed or endodontically treated teeth.

• Patients participated in a clinical trial within 6 months before beginning of this trial.

• Patients who decline to be involved in the study or sign the written consent.

• Patients unable to return for the follow up visits.

Related Conditions & MeSH terms

• Dental Caries
• Tooth Decay

Intervention

Other:
• self-adhesive resin restoration
Light cured, hybrid resin composite material which contains polymerization modulator that lessens its degree of polymerization shrinkage

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Minya University.	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Anwar RS, Hussein YF, Riad M. Optical behavior and marginal discoloration of a single shade resin composite with a chameleon effect: a randomized controlled clinical trial. BDJ Open. 2024 Feb 20;10(1):11. doi: 10.1038/s41405-024-00184-w. — View Citation

Cieplik F, Scholz KJ, Anthony JC, Tabenski I, Ettenberger S, Hiller KA, Buchalla W, Federlin M. One-year results of a novel self-adhesive bulk-fill restorative and a conventional bulk-fill composite in class II cavities-a randomized clinical split-mouth study. Clin Oral Investig. 2022 Jan;26(1):449-461. doi: 10.1007/s00784-021-04019-y. Epub 2021 Jun 15. — View Citation

Ellithy MS, Abdelrahman MH, Afifi RR. Comparative clinical evaluation between self-adhesive and conventional bulk-fill composites in class II cavities: A 1-year randomized controlled clinical study. J Esthet Restor Dent. 2024 Apr 24. doi: 10.1111/jerd.13242. Online ahead of print. — View Citation

Fidan M. The effects of different repolishing procedures on the color change of bulk-fill resin composites. Eur Oral Res. 2024 Jan 5;58(1):14-21. doi: 10.26650/eor.20231234627. — View Citation

Rathke A, Pfefferkorn F, McGuire MK, Heard RH, Seemann R. One-year clinical results of restorations using a novel self-adhesive resin-based bulk-fill restorative. Sci Rep. 2022 Mar 10;12(1):3934. doi: 10.1038/s41598-022-07965-z. — View Citation

Uctasli MB, Garoushi S, Uctasli M, Vallittu PK, Lassila L. A comparative assessment of color stability among various commercial resin composites. BMC Oral Health. 2023 Oct 24;23(1):789. doi: 10.1186/s12903-023-03515-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evaluation of color stability and marginal discoloration of resin restorations after aging in the patient mouth.	Clinical evaluation of degree of color change of resin restorations after aging in the patient mouth.	6 months