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Clinical Evaluation of Posterior Indirect Adhesive Restorations

Primary Purpose

Dental Caries, Endodontically Treated Teeth, Dental Restoration Failure of Marginal Integrity

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Indirect adhesive restoration of posterior teeth
Sponsored by
Okan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Indirect restoration, Adhesive restoration, Cementation, Composite resin

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul Okan University Faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Indirect restorations luted with light-cured composite resin.

Arm Description

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.

Outcomes

Primary Outcome Measures

FDI World Dental Federation criteria
Restorations will be evaluated clinically using dental explorer, mirror, dental loupe and radiographically according to FDI World Dental Federation criteria over 3-year period. Two calibrated observers who are not involved in the placement of the restorations are responsible for the evaluations. Esthetic properties: Surface lustre, surface staining, marginal staining, color match and translucency, esthetical anatomical form Functional properties: Fracture of material and retention, marginal adaptation, occlusal contour and wear, approximal anatomical form, radiographic examination, patient's view. Biological properties: Recurrence of caries, erosion, abfraction, tooth integrity, periodontal response, adjacent mucosa, oral and general health.

Secondary Outcome Measures

Full Information

First Posted
February 29, 2020
Last Updated
March 3, 2020
Sponsor
Okan University
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1. Study Identification

Unique Protocol Identification Number
NCT04293770
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
June 8, 2020 (Anticipated)
Study Completion Date
July 8, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Endodontically Treated Teeth, Dental Restoration Failure of Marginal Integrity, Wear, Occlusal, Indirect Posterior Restoration
Keywords
Indirect restoration, Adhesive restoration, Cementation, Composite resin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A Prospective Clinical Trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Indirect restorations luted with light-cured composite resin.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Indirect adhesive restoration of posterior teeth
Other Intervention Name(s)
Ceramic onlay or overlay
Intervention Description
Indirect restoration of significant loss of dental hard tissue
Primary Outcome Measure Information:
Title
FDI World Dental Federation criteria
Description
Restorations will be evaluated clinically using dental explorer, mirror, dental loupe and radiographically according to FDI World Dental Federation criteria over 3-year period. Two calibrated observers who are not involved in the placement of the restorations are responsible for the evaluations. Esthetic properties: Surface lustre, surface staining, marginal staining, color match and translucency, esthetical anatomical form Functional properties: Fracture of material and retention, marginal adaptation, occlusal contour and wear, approximal anatomical form, radiographic examination, patient's view. Biological properties: Recurrence of caries, erosion, abfraction, tooth integrity, periodontal response, adjacent mucosa, oral and general health.
Time Frame
at 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gulsah YENIER, DDS,PhD
Phone
+905547810176
Email
gulsahyenier@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elif CIFTCIOGLU, DDS,PhD
Phone
+902166771630
Email
elifcif@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulsah YENIER, DDS, PHD
Organizational Affiliation
Istanbul Okan University Faculty of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Okan University Faculty of Dentistry
City
Istanbul
State/Province
Tuzla
ZIP/Postal Code
34959
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23695612
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.
Results Reference
background
PubMed Identifier
28653051
Citation
Veneziani M. Posterior indirect adhesive restorations: updated indications and the Morphology Driven Preparation Technique. Int J Esthet Dent. 2017;12(2):204-230.
Results Reference
background
PubMed Identifier
20628774
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.
Results Reference
background
PubMed Identifier
30073216
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.
Results Reference
background
PubMed Identifier
26355440
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.
Results Reference
background
PubMed Identifier
18350945
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.
Results Reference
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Clinical Evaluation of Posterior Indirect Adhesive Restorations

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