Clinical trial NCT04293770: Clinical Evaluation of Posterior Indirect Adhesive Restorations
Official title: Clinical Performance of Indirect Adhesive Restorations Luted With Light-cured Composite Resin: A 3-year Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Endodontically Treated Teeth
Dental Restoration Failure of Marginal Integrity
Wear, Occlusal
Indirect Posterior Restoration
Keywords: Indirect restoration
Adhesive restoration
Cementation
Composite resin
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A Prospective Clinical Trial
Primary purpose: TREATMENT

Brief summary: Clinical performance of indirect adhesive restorations - onlays, overlays- luted with light-cured composite resin will be evaluated over three years.

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 and radiographically according to FDI World Dental Federation criteria over 3-year period. 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).

Eligibility criteria: 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

Primary outcomes:
measure: FDI World Dental Federation criteria
timeFrame: at 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Okan University Faculty of Dentistry
state: Tuzla
Study officials:
affiliation: Istanbul Okan University Faculty of Dentistry
name: Gulsah YENIER, DDS, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Veneziani M. Posterior indirect adhesive restorations: updated indications and the Morphology Driven Preparation Technique. Int J Esthet Dent. 2017;12(2):204-230.
citation: 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.
citation: 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.
citation: 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.
citation: 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.