Follow-up of Indirect Restorations Luted With Different Adhesive Resin Cement

October 3, 2023 updated by: yeldaerdem, Istanbul Medipol University Hospital

2 Year Follow-up of Indirect Resin Composite Restorations Luted With Different Adhesive Resin Cement: A Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design The ethical committee of Istanbul Medipol University approved this clinical study. Patients were given written informed consent to participate before treatment and agreed to a recall program at baseline 2 weeks, 6 months, and thereafter annually. All restorative procedures were carried out by one experienced dentist from the Department of Restorative Dentistry at Istanbul Medipol University.

Inclusion and exclusion criteria

Patients in need of removal of old large amalgam restorations or having extensive caries lesions were recruited for the study. Inclusion and exclusion criteria were as follows:

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. Exclusion criteria included the presence of teeth with severe periodontal problems, high caries risk, and bruxism.

Cavities were prepared according to common principles, which included an occlusal reduction of 1.5-2 mm with a wide isthmus and rounded occlusal-axial angles, and an axial wall of 1.5 mm in thickness. Where possible, the gingival margins were prepared entirely in enamel at the cemento-enamel junction, and cavities for overlays included both buccal and lingual/palatal cusps. Both cavity types (onlays and overlays) were prepared with rounded internal angles, with a divergence of 6-15° between the walls and margins with a 90° cave surface.

Full-arch impressions were made with a single impression/double mixing technique using polyether material (Impregum Penta H Duoso, 3M ESPE, Minn, USA) cavity preparations were provisionalized for 1 week with photo-polymerized provisional material (Clip, Voco, Cuxhaven, Germany). All onlays were definitively inserted within 1 week after impression. After the removal of provisional restorations, the teeth were thoroughly cleaned with a prophylaxis brush and pumice.

After adjustment when needed, the restorations were luted adhesively under a rubber dam, employing a total-etch system in group A. The prepared teeth were initially cleaned with pumice slurry and etched with 35% phosphoric acid gel (Ultra-etch, Ultradent, South Jordan, UT, USA). The dentin adhesive system (Syntac Classic, Ivoclar Vivadent, Liechtenstein) was then applied uniform and gently air thinned. The internal surface of the restorations was silanized (Monobond S, Ivoclar Vivadent), waited for its reaction for 60 s and the solvent was evaporated with oil-free compressed air. The onlays and overlays were luted adhesively with etch and rinse, dual cure resin cement (Variolink II, Ivoclar Vivadent). In Group B were luted using a self-adhesive resin cement (Relyx U200, 3M ESPE).

Excess resin cement was removed in all cases with an explorer, a brush, and dental floss interproximally. Each only surface was light-cured for 40 s with a polymerization light (Elipar Highlight, 3M Espe, Seefeld, Germany). After placement and removal of the rubber dam, static and dynamic occlusion was adjusted using fine grit diamond burs, then inlays were finished with disks and strips (Sof-Lex, 3M Dental Products, St. Paul, MN, USA).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34290
        • Yelda Erdem Hepsenoglu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria Patients in need of removal of old large amalgam restorations or having extensive caries lesions were recruited for the study.

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.

Exclusion criteria Exclusion criteria included the presence of teeth with severe periodontal problems, high caries risk, and bruxism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: In Group A,(Variolink II, Ivoclar Vivadent).
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.
resin cement (Variolink II, Ivoclar Vivadent)-self-adhesive resin cement (Relyx U200, 3M ESPE)
Other Names:
  • 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-
Active Comparator: In Group B, (Relyx U200, 3M ESPE).
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.
resin cement (Variolink II, Ivoclar Vivadent)-self-adhesive resin cement (Relyx U200, 3M ESPE)
Other Names:
  • 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-

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endocrowns FDI evaluation
Time Frame: 2 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aesthetic :Functional :Biological :Vitality-resin cement
Time Frame: 2 weeks and 6, 12 months and 2 year
Surface luster-Surface staining-Colour stability and translucency-Anatomic form.Fracture and retention-Marginal adaptation-Wear -Proximal contact-Patient's viewFracture and retention-Marginal adaptation-Wear -Proximal contact-Patient's view.Postoperative hypersensitivity-Recurrent of caries, erosion, abfraction-Tooth integrity-Vitality-resin cement
2 weeks and 6, 12 months and 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Study Chair: yelda erdem hepsenoglu, Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2017

Primary Completion (Actual)

May 10, 2019

Study Completion (Actual)

April 10, 2022

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

September 20, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Indirect Resin Composite

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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