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

M

Minia University

Status

Enrolling

Conditions

Tooth Decay

Treatments

Other: self-adhesive resin restoration

Study type

Interventional

Funder types

Other

Identifiers

NCT06463574
self-adhesive resin composite

Details and patient eligibility

About

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).

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

25 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

Surefil one bulk-fill composite
Experimental group
Description:
Restorative material applied directly to the tooth without adhesive appliaction.
Treatment:
Other: self-adhesive resin restoration
Filtek One bulk-fill composite
Active Comparator group
Description:
Restorative material that is applied to the tooth after adhesive application.
Treatment:
Other: self-adhesive resin restoration

Trial contacts and locations

1

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Central trial contact

Nermin Al-sayed Mahmoud, Associate professor; Nourhan Samir Soliman, Assisstant Lecturer

Data sourced from clinicaltrials.gov

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