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

NCT06463574 | Recruiting

• 1 other identifier: self-adhesive resin composite
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Tooth Decay

Keywords

Color stability; Aging; Self-adhesive

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Surefil one bulk-fill composite

EXPERIMENTAL

Restorative material applied directly to the tooth without adhesive appliaction.

Other: self-adhesive resin restoration

Filtek One bulk-fill composite

ACTIVE COMPARATOR

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

Other: self-adhesive resin restoration

Interventions

self-adhesive resin restoration OTHER

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

Also known as: Surefil one

Filtek One bulk-fill composite; Surefil one bulk-fill composite

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Faculty of Dentistry, Minya University.

Minya, 61519, Egypt

RECRUITING

Related Publications (6)

• 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.

  PMID: 38655672 BACKGROUND

• 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.

  PMID: 35273277 BACKGROUND

• 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.

  PMID: 34129074 BACKGROUND

• 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.

  PMID: 38378771 BACKGROUND

• 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.

  PMID: 38481725 BACKGROUND

• 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.

  PMID: 37875872 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Wael Essam Jamil, Professor

  Faculty of Dental Medicine for Girls, AL-Azhar University

  STUDY DIRECTOR

Central Study Contacts

Nourhan Samir Soliman, Assisstant Lecturer

CONTACT

1066175951; nourhan.samir@pua.edu.eh

Nermin Al-sayed Mahmoud, Associate professor

CONTACT

1125529583; nermin.alsayed@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 18, 2024
• Study Start: June 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months

Locations

EG (1)