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

NCT04589416 | Completed

• 1 other identifier: 5930
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Dental Adhesive Materials

Keywords

Adhesive system; Clinical follow-up; Class I restoration; Composite resin; FDI; USPHS

Outcome Measures

Primary Outcomes (2)

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

  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.

  One years

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

  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.

  Two years

Study Arms (3)

Single Bond 2

ACTIVE COMPARATOR

Single Bond 2 is a traditional etch and rinse adhesive system. It is used to bond the composite resin to the dental tissues. It was applied to the cavities opened in accordance with the manufacturer's instructions.

Other: Dental adhesive materials.

Clearfil SE Bond

ACTIVE COMPARATOR

Clearfil SE bond is traditional two step self-etch adhesive system. It is used to bond the composite resin to the dental tissues. It was applied to the cavities opened in accordance with the manufacturer's instructions.

Other: Dental adhesive materials.

Tri-S Bond

ACTIVE COMPARATOR

Tri-S bond is traditional one step self-etch adhesive system. It is used to bond the composite resin to the dental tissues. It was applied to the cavities opened in accordance with the manufacturer's instructions.

Other: Dental adhesive materials.

Interventions

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.

Clearfil SE Bond; Single Bond 2; Tri-S Bond

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nuh Naci Yazgan University: lead

Study Officials

• Nazire Nurdan Çakır

  Nuh Naci Yazgan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof Nazire Nurdan Çakır

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: October 19, 2020
• Study Start: February 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: October 19, 2020

Record last verified: 2020-10