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

NCT ID: NCT06463574

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2024-12-31

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.

Conditions

Tooth Decay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Surefil one bulk-fill composite

Restorative material applied directly to the tooth without adhesive appliaction.

Group Type: EXPERIMENTAL

self-adhesive resin restoration

Intervention Type: OTHER

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

Filtek One bulk-fill composite

Restorative material that is applied to the tooth after adhesive application.

Group Type: ACTIVE_COMPARATOR

self-adhesive resin restoration

Intervention Type: OTHER

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

Interventions

self-adhesive resin restoration

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

Intervention Type: OTHER

Other Intervention Names

Surefil one

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Nourhan Samir Soliman Ibrahim

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wael Essam Jamil, Professor

Role: STUDY_DIRECTOR

Faculty of Dental Medicine for Girls, AL-Azhar University

Locations

Faculty of Dentistry, Minya University.

Minya, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nourhan Samir Soliman, Assisstant Lecturer

Role: CONTACT

nourhan.samir@pua.edu.eh

1066175951 ext. +20

Nermin Al-sayed Mahmoud, Associate professor

Role: CONTACT

nermin.alsayed@yahoo.com

1125529583 ext. +20

Facility Contacts

Nourhan S Soliman, Doctor

Role: primary

nourhan.samir@pua.edu.eg

1066175951 ext. +20

Nermin A Mahmoud, Doctor

Role: backup

nermin.alsayed@yahoo.com

1125529583 ext. +20

References

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 Sep;36(9):1311-1325. doi: 10.1111/jerd.13242. Epub 2024 Apr 24.

Reference Type: BACKGROUND

PMID: 38655672 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35273277 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34129074 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38378771 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38481725 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37875872 (View on PubMed)

Other Identifiers

self-adhesive resin composite

Identifier Type: -

Identifier Source: org_study_id