- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04838483
Clinical Performance of Posterior Indirect Adhesive Restorations
Clinical Performance of Indirect Adhesive Restorations Luted With Light-cured Composite Resin
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Indirect adhesive restorations are indicated in large Class II defects, replacement of large compromised existing restorations or endodontically treated teeth where cuspal protection is required. The need to perform adhesive restorations of posterior teeth is not only linked to esthetic purposes, but also have possibility of strengthening the remaining tooth structure. Indirect technique decreases polymerization shrinkage, reduces microleakage and also improves the marginal seal when comparing direct resin composites. Furthermore, it provides improved physical and mechanical properties, ideal occlusal morphology, more precise control of proximal contours and contacts. Indirect adhesive restorations are classically delivered with an adhesive procedure including dual-cure cement. Updated approaches now include the use of composite resins as luting agent.
This study will be carried out as a prospective study, with assessment of the restorations after three years. PASS 11 Software was used to calculate the sample size. At least 77 indirect adhesive restorations will be included for this study. Patients referred to Istanbul Okan University Faculty of Dentistry between 2016-2017 who had returned for the baseline recall and at least one year recall after the treatment will be invited for eligibility to participate in the study. 83 indirect adhesive restorations in at least 60 patients will be included. The patients who will not meet all the inclusion criteria will be excluded from the study. A signed informed consent form will be obtained from all patients before beginning the study.
Restorations will be evaluated clinically according to FDI World Dental Federation criteria. Three main groups- esthetic, functional, biological properties- and their sub-categorizes of FDI World Dental Federation criteria will be scored on a scale of 1 to 5. Statistical analysis will be performed using R (v.3.5.3) Software and the SIGN.test function in the BSDA package (p <0.05).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gulsah YENIER, DDS, PhD
- Phone Number: +905547810176
- Email: gulsahyenier@gmail.com
Study Contact Backup
- Name: Elif Ciftcioglu, DDS, PhD
- Phone Number: +902166771630
- Email: elifcif@yahoo.com
Study Locations
-
-
Tuzla
-
Istanbul, Tuzla, Turkey, 34959
- Recruiting
- Istanbul Okan University Faculty of Dentistry
-
Contact:
- Gulsah YENIER, DDS, PhD
- Phone Number: +905547810176
- Email: gulsahyenier@gmail.com
-
Principal Investigator:
- Gulsah YENIER, DDS,PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Significant loss of dental hard tissue
- Endodontically treated teeth in posterior region
- Replacement of large compromised existing restoration
- Large Class II restoration
- Age of 18-60 years
- Good oral hygiene
- Presence of interproximal contact to at least one neighboring teeth • In occlusion with antagonist teeth
- Cavity preparation with at least one cuspal coverage
Exclusion Criteria:
- Serious medical problems or allergies to substances and/or products to be used
- Severe periodontal problems
- Poor oral hygiene
- Direct pulp capping
- Presence of parafunctional behaviors
- Pregnant or breast feeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Indirect restorations luted with light-cured composite resin.
Subjects for the study will be identified from patients who had treated with indirect adhesive restorations onlay or overlay during the period 2016 to 2017 was performed at Istanbul Okan University Faculty of Dentistry by an experienced clinician. Local anesthesia was applied if necessary. After caries and/or failed restorations were removed, the preparations were performed according to defined principles for adhesive onlays/overlays. At least one cuspal coverage was required for each restoration. All undercuts were eliminated using composite resin. Following the cavity preparation, immediate dentin sealing was applied and polymerized prior to impression taking. Indirect restorations were designed and fabricated with CEREC system. Surface treatments and clinical protocols were performed under manufacturer's instructions. Adhesive cementation with composite resin procedure was carried out with the rubber-dam isolation. |
Indirect restoration of significant loss of dental hard tissue
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival rate
Time Frame: at 5 years
|
FDI World Dental Federation criteria functional properties
|
at 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Esthetic properties
Time Frame: at 5 years
|
FDI World Dental Federation criteria
|
at 5 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
- D'Arcangelo C, Zarow M, De Angelis F, Vadini M, Paolantonio M, Giannoni M, D'Amario M. Five-year retrospective clinical study of indirect composite restorations luted with a light-cured composite in posterior teeth. Clin Oral Investig. 2014;18(2):615-24. doi: 10.1007/s00784-013-1001-8. Epub 2013 May 22.
- Veneziani M. Posterior indirect adhesive restorations: updated indications and the Morphology Driven Preparation Technique. Int J Esthet Dent. 2017;12(2):204-230.
- Magne P, Razaghy M, Carvalho MA, Soares LM. Luting of inlays, onlays, and overlays with preheated restorative composite resin does not prevent seating accuracy. Int J Esthet Dent. 2018;13(3):318-332.
- D'Arcangelo C, Vanini L, Casinelli M, Frascaria M, De Angelis F, Vadini M, D'Amario M. Adhesive Cementation of Indirect Composite Inlays and Onlays: A Literature Review. Compend Contin Educ Dent. 2015 Sep;36(8):570-7; quiz 578.
- Naeselius K, Arnelund CF, Molin MK. Clinical evaluation of all-ceramic onlays: a 4-year retrospective study. Int J Prosthodont. 2008 Jan-Feb;21(1):40-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2/25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Dental Caries
-
Ain Shams UniversityCompletedPulpitis | Caries | Caries,Dental | Reversible Pulpitis | Caries Class I | Caries; DentinEgypt
-
National University of San Marcos, PeruNot yet recruitingPit and Fissure Caries | Caries,Dental | Sealant DentalPeru
-
University of MinnesotaCompletedUsing Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood CariesCaries | Caries,DentalUnited States
-
3MUniversity of MichiganActive, not recruiting
-
Hue University of Medicine and PharmacyRecruitingOcclusal Caries | Caries,Dental | Caries; InitialVietnam
-
Rawda Hesham Abd ElAzizRecruitingCaries,Dental | Caries Class IIEgypt
-
The University of Texas Health Science Center,...National Institute of Dental and Craniofacial Research (NIDCR)RecruitingCaries,DentalUnited States
-
Federal University of PelotasRecruiting
-
Kompetansesenteret Tannhelse Midt (TkMidt)Karolinska Institutet; University of Bergen; Norwegian University of Science... and other collaboratorsActive, not recruiting
-
Marmara UniversityCompleted
Clinical Trials on Indirect adhesive restoration of posterior teeth
-
Okan UniversityUnknownDental Caries | Endodontically Treated Teeth | Wear, Occlusal | Dental Restoration Failure of Marginal Integrity | Indirect Posterior RestorationTurkey
-
University of ValenciaRecruitingSurvival Rate | Clinical Performance | SuccessSpain
-
Cairo UniversityCompleted
-
Universidade Federal do ParaRecruitingSclerotic Dentine | Non Carious Cervical LesionBrazil
-
Okan UniversityBezmialem Vakif UniversityCompleted
-
Hospices Civils de LyonUnknown
-
M.D. Anderson Cancer CenterGemin XTerminated
-
University of AthensUnknownNon-carious Cervical Lesions | Adhesive PerformanceGreece
-
Postgraduate Institute of Dental Sciences RohtakCompleted
-
Istanbul Medipol University HospitalCompletedDental Restoration FailuresTurkey