NCT06058026

Brief Summary

Universal adhesive solutions have just entered the market, allowing dentists to choose an adhesive strategy based on the needs of patients and clinical situations. Theses adhesives contain a primer/adhesive resin mix in a single bottle for multi-mode etch-and-rinse or self-etch applications. The aim of this study was to evaluate the clinical performance of composite resins with diffent adesive agents on Class II cavities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
Last Updated

April 23, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

September 21, 2023

Last Update Submit

April 20, 2024

Conditions

Caries; Dentin

Outcome Measures

Primary Outcomes (1)

  • Evaluation of class II restorative materials restored with different adhesives

    Restored teeth were evaluated according to FDI criteria.

    Baseline

Interventions

World Dental Federation criteria (FDI)OTHER

Restorations were evaluated with FDI criteria.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Teeth with primary caries, including at least one-third of the dentin (MO or DO), were included in the study.

You may qualify if:

  • Individuals without systemic disease
  • Individuals with good oral hygiene
  • Must be a minimum of one carious defect
  • Must be at least 18 years old
  • Must have vital teeth in antagonist and proximal contact.

You may not qualify if:

  • Pregnant or breastfeeding women
  • Receiving orthodontic treatment
  • Bruxism habit
  • Direct or indirect pulp coverage
  • Allergy to resin-based products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammet Karadaş

Rize, Merkez, 53100, Turkey (Türkiye)

Location

Study Officials

  • Muhammet Karadaş, PhD

    Recep Tayyip Erdogan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistan Professor

Study Record Dates

First Submitted

September 21, 2023

First Posted

September 28, 2023

Study Start

December 31, 2020

Primary Completion

September 15, 2021

Study Completion

September 17, 2022

Last Updated

April 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)