NCT05551481

Brief Summary

Objective: To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years. Methods: From February 2017 to May 2017, a total of 43 patients (21 men, 22 women; mean age.), received 48 onlay restorations made of laboratory-processed indirect composite (Gradia, GC, Japan). 27 onlay restorations (Group A) were luted using an etch and rinse resin cement (Variolink II, Ivoclar Vivadent) and 22 onlay restorations (Group B) were luted using a self-adhesive resin cement (Relyx U200, 3M ESPE). Patients were followed until May 2019. Two independent calibrated examiners evaluated the restorations at 3-time points: 2 weeks after placement (baseline), 6 months, and then annually, using the modified USPHS/FDI criteria.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

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

February 10, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

2.2 years

First QC Date

August 19, 2022

Last Update Submit

October 3, 2023

Conditions

Dental Restoration Failures

Keywords

indirect composite

Outcome Measures

Primary Outcomes (1)

  • Endocrowns FDI evaluation

    this clinical trial aimed to evaluate posterior teeth restored with indirect resin composites and compare clinical performances of two resin cement (one etch and rinse and one self-adhesive) 2 weeks and 6, 12, 24 months, and 5 years after the luting of indirect resin composite restorations using the modified USPHS/FDI criteria.

    2 year

Secondary Outcomes (1)

  • Aesthetic :Functional :Biological :Vitality-resin cement

    2 weeks and 6, 12 months and 2 year

Study Arms (2)

In Group A,(Variolink II, Ivoclar Vivadent).

EXPERIMENTAL

In Group A, the onlays and overlays were luted adhesively with etch and rinse, dual cure resin cement (Variolink II, Ivoclar Vivadent).

Procedure: To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years.

In Group B, (Relyx U200, 3M ESPE).

ACTIVE COMPARATOR

In Group B the onlays and overlays were luted using a self-adhesive resin cement (Relyx U200, 3M ESPE).

Procedure: To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years.

Interventions

To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years.PROCEDURE

resin cement (Variolink II, Ivoclar Vivadent)-self-adhesive resin cement (Relyx U200, 3M ESPE)

Also known as: restorations made of laboratory-processed- luted using an etch and rinse resin cement (Variolink II, Ivoclar Vivadent) and 22 onlay restorations (Group B) were luted using a self-
In Group A,(Variolink II, Ivoclar Vivadent).In Group B, (Relyx U200, 3M ESPE).

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details18-65
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults of at least 18 years of age, with good oral hygiene, having an antagonist tooth in occlusion, being mentally in a good state to provide written consent to participate in the clinical study, and willing to attend the scheduled follow-up appointments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yelda Erdem Hepsenoglu

Istanbul, 34290, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Variolink

Study Officials

  • yelda erdem hepsenoglu

    Medipol University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 19, 2022

First Posted

September 22, 2022

Study Start

February 10, 2017

Primary Completion

May 10, 2019

Study Completion

April 10, 2022

Last Updated

October 5, 2023

Record last verified: 2023-10

Locations

TU(1)