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Completed

NCT Number: NCT05161559

Adhesive Performance of Glass Ionomer and Resin Based Adhesive Systems: A 3 Years Prospective Clinical Evaluation

This study aimed to clinically evaluate the 3-years clinical performance of glass ionomer and resin based adhesive systems in Class V restorations.

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Key information

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, 35511, Egypt

About this study

The formulated null hypothesis was that there is no significant difference in the clinical performances between glass ionomer and resin based adhesive systems in Class V restorations for 3-years.

The research question was as follows: Do glass ionomer adhesives in class V restorations present better clinical performances than resin based adhesive systems according to the modified United States Public Health Service (modified-USPHS) criteria?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with primary caries involving cervical surface only with ICDAS 2 and 3.
  • Patients with normal and full occlusion.
  • Patients with tooth gives positive response to testing with an electric pulp tester.
  • Patients must have a good oral hygiene.
  • Patients with opposing teeth should be natural with no restorations.

Exclusion criteria

  • High caries risk patients with extremely poor oral hygiene.
  • Patients involved in orthodontic treatment or periodontal surgery.
  • Patients with periodontally involved teeth (chronic periodontitis).
  • Patients with heavy bruxism habits and clenching.
  • Patients with abutments should be excluded.

Treatment and study plan

Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA)

Procedure

Etching enamel surface using phosphoric acid gel (3M ESPE, St. Paul, MN, USA)

Self-etch adhesive (Kuraray, Tokyo, Japan)

Procedure

No Etching enamel surface using phosphoric acid (self-etch technique) (Kuraray, Tokyo, Japan)

Chemical bond adhesive (GC, Corporation, Tokyo, Japan)

Procedure

Chemical bond with hydroxyapatite crystals of Enamel (GC, Corporation, Tokyo, Japan)

Primary outcomes

  1. Percentage % of patients with marginal staining

    Time frame: 3 years after restoration procedure

    Percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Adhesive Performance of Glass Ionomer Versus Resin Based Adhesive Systems

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2021
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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