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Completed

NCT Number: NCT04589416

Clinical Evaluation Of Class I Composite Resin Restorations Using Three Different Adhesive Systems

Nowadays, most composite resins require the use of an adhesive material prior to application. For this purpose, etch & rinse (ER) and self-etch (SE) systems have been used for many years. While many in-vitro studies have been conducted in the literature comparing three adhesive systems, the number of clinical studies is less and inadequate. Therefore, the aim of this study was to investigate the effect of 3 different adhesive systems commonly used in clinics on the success of class I composite restorations using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS).

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Key information

Age range

18 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Nowadays, most composite resins require the use of an adhesive material prior to application. For this purpose, etch & rinse (ER) and self-etch (SE) systems have been used for many years. Compared to SE systems, which are simplified and very easy to use, requiring less technical precision, traditional ER systems are still very popular and preferred by dentists. However, current researchers indicate that ER systems are more effective on enamel than dentin and that this effect is better than SE systems. SE systems are approaches in which the acid application and washing step are eliminated clinically and the possibility of making mistakes during the application and manipulation is reduced. An important advantage of these systems is that demineralization and resin infiltration occurs at the same time. Clinically, the application times are shorter than traditional systems. Two-steps SE systems have been used for a long time. In this system, the need for a separate acidic primer application has needed clinicians reason to search for single-steps bonding agents. And, in recent years, single-step SE systems also called "all in one", have been developed that include all steps of pickling, primer application, and adhesive agent application. However, there are studies showing that these systems do not perform as well as two-step SE systems. While many in-vitro studies have been conducted in the literature comparing three adhesive systems, the number of clinical studies is less and inadequate. Therefore, the aim of this study was to investigate the effect of 3 different adhesive systems commonly used in clinics on the success of class I composite restorations using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • At least 3 Class-I caries lesions
  • Good health
  • Acceptable level of oral hygiene

Exclusion criteria

  • Did not have four caries lesions at least
  • Did not have Class-II caries lesions
  • Deep caries reaching the pulp
  • The patients are not 18-22 years old
  • Bruxism
  • Periodontal disease
  • Refused to participate

Treatment and study plan

Dental adhesive materials.

Other

It is used to bond the composite resin to the dental tissues. That is, it is used to bond dental filling materials to dental tissues.

Primary outcomes

  1. Clinical Evaluation Of Class I Composite Resin Restorations Using Three Different Adhesive Systems with FDI and USPHS criteria

    Time frame: One years

    FDI; World Dental Federation USPHS; United States Public Health Service. Two calibrated observers who were blinded to the objective of this study performed the evaluations.

  2. Clinical Evaluation Of Class I Composite Resin Restorations Using Three Different Adhesive Systems with FDI and USPHS criteria

    Time frame: Two years

    FDI; World Dental Federation USPHS; United States Public Health Service. Two calibrated observers who were blinded to the objective of this study performed the evaluations.

Sponsors and collaborators

Lead sponsor

Nuh Naci Yazgan University

Other

Registry information

Official study title

Erciyes University Clinical Research Ethics Committee

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 19, 2020
Registry last updated
Oct 19, 2020

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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