Skip to content

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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06463574
Enrollment
20
Registered
2024-06-18
Start date
2024-06-30
Completion date
2024-12-31
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Decay

Keywords

Color stability, Aging, Self-adhesive

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.

Interventions

OTHERself-adhesive resin restoration

Light cured, hybrid resin composite material which contains polymerization modulator that lessens its degree of polymerization shrinkage

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

This study is a prospective randomized clinical trial with a follow up of 6 months. The clinical examiner and the participant will be kept unaware of the treatment being administrated.

Intervention model description

A total of 20 patients will be selected and divided randomly into two main groups according to the type of composite used, the first group will use Surefil one self-adhesive bulk-fill composite for restoring 10 posterior class I cavities and the second group will use 3M Filtek One high viscosity bulk-fill composite for restoring 10 posterior class I cavities.

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical evaluation of color stability and marginal discoloration of resin restorations after aging in the patient mouth.6 monthsClinical evaluation of degree of color change of resin restorations after aging in the patient mouth.

Countries

Egypt

Contacts

Primary ContactNourhan Samir Soliman, Assisstant Lecturer
nourhan.samir@pua.edu.eh1066175951
Backup ContactNermin Al-sayed Mahmoud, Associate professor
nermin.alsayed@yahoo.com1125529583

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026