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

Not Applicable

Recruiting

• Conditions: Tooth Decay
• Interventions: Other: self-adhesive resin restoration

• Registration Number: NCT06463574
• Lead Sponsor: Minia University

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2024-05-23
• Status Verified: 2024-06
• Study Start: 2024-06
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-18
• Primary Completion: 2024-11
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surefil one bulk-fill composite	self-adhesive resin restoration	Restorative material applied directly to the tooth without adhesive appliaction.
Filtek One bulk-fill composite	self-adhesive resin restoration	Restorative material that is applied to the tooth after adhesive application.

Primary Outcome Measures

Name	Time	Method
Clinical evaluation of color stability and marginal discoloration of resin restorations after aging in the patient mouth.	6 months	Clinical evaluation of degree of color change of resin restorations after aging in the patient mouth.

Trial Locations

Locations (1)

Faculty of Dentistry, Minya University.; 🇪🇬 Minya, Egypt