Evaluation of the Clinical Success of Direct Restorations of Endodontically Treated Posterior Teeth in the Presence of Parafunction: A Pilot Study
NCT ID: NCT06870188
Last Updated: 2025-03-11
Study Results
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Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2023-01-31
2025-02-25
Brief Summary
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Bruxism is a repetitive jaw-muscle activity characterized by clenching and/or grinding of teeth. The possible outcomes of bruxism include wear and/or fractures in the teeth and restorations. Therefore, the choice of restorative methods and materials for restorations in bruxist individuals is of great importance. Direct adhesive restorations are the first treatment option for endodontically treated teeth with no excessive material loss and/or those that have lost vitality due to trauma. Over the past decade, the use of fiber-reinforced materials has been recommended to prevent catastrophic fractures. Fiber-reinforced materials have been developed and introduced to the market based on the idea that a restorative material that distributes or absorbs stress in high-stress areas will protect the underlying tooth structure.
Although there are numerous studies on the mechanical durability of restorative treatments for endodontically treated teeth in cases with parafunctional habits, there are limited clinical studies regarding the clinical performance of these methods.
The study included 32 premolar or molar teeth with Class 1 and Class 2 cavity types and a remaining wall thickness of at least 3 mm, which had undergone endodontic treatment from volunteer participants. The teeth randomly assigned were divided into two groups (n=16): Group 1: fiber-reinforced composite restoration (EverX flow, GC) (FRCR), Group 2: composite restoration (Gneal Posterior, GC) (CR). The restorations were evaluated at 6 and 12 months using the FDI criteria.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fiber-reinforced composite restoration (FRCR)
After the cavity preparation, an adhesive was applied to the tooth, and a short fiber-reinforced flowable composite resin (EverX flow, GC) was used as the dentin replacement material. It was then covered with posterior composite resin (Gneal Posterior, GC).
Composite Restoration
The study included premolar or molar teeth with Class 1 and Class 2 cavity types and a remaining wall thickness of at least 3 mm, which had undergone endodontic treatment from volunteer participants. The teeth randomly assigned were divided into two groups: Group 1: fiber-reinforced composite restoration (FRCR), Group 2: composite restoration (CR). Direct composite restorations with or without fiber reinforced material were applied. The restorations were evaluated at 6 and 12 months using the FDI criteria.
Clinical evaluation
The restorations were evaluated by two experienced and fully blinded observers according to the functional, esthetic, and biological criteria. The criteria were scored from 1 to 5 (sufficient/acceptable= score 1 to 3, insufficient/inacceptable but repair possible= score 4, and insufficient/inacceptable but repair not possible/reasonable= score 5). Scores of 4 and 5 were considered as failure in the restoration.
Composite restoration (CR)
After the cavity preparation, an adhesive was applied to the tooth, and only posterior composite resin material (Gneal Posterior, GC) was used for filling whole of the cavity
Composite Restoration
The study included premolar or molar teeth with Class 1 and Class 2 cavity types and a remaining wall thickness of at least 3 mm, which had undergone endodontic treatment from volunteer participants. The teeth randomly assigned were divided into two groups: Group 1: fiber-reinforced composite restoration (FRCR), Group 2: composite restoration (CR). Direct composite restorations with or without fiber reinforced material were applied. The restorations were evaluated at 6 and 12 months using the FDI criteria.
Clinical evaluation
The restorations were evaluated by two experienced and fully blinded observers according to the functional, esthetic, and biological criteria. The criteria were scored from 1 to 5 (sufficient/acceptable= score 1 to 3, insufficient/inacceptable but repair possible= score 4, and insufficient/inacceptable but repair not possible/reasonable= score 5). Scores of 4 and 5 were considered as failure in the restoration.
Interventions
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Composite Restoration
The study included premolar or molar teeth with Class 1 and Class 2 cavity types and a remaining wall thickness of at least 3 mm, which had undergone endodontic treatment from volunteer participants. The teeth randomly assigned were divided into two groups: Group 1: fiber-reinforced composite restoration (FRCR), Group 2: composite restoration (CR). Direct composite restorations with or without fiber reinforced material were applied. The restorations were evaluated at 6 and 12 months using the FDI criteria.
Clinical evaluation
The restorations were evaluated by two experienced and fully blinded observers according to the functional, esthetic, and biological criteria. The criteria were scored from 1 to 5 (sufficient/acceptable= score 1 to 3, insufficient/inacceptable but repair possible= score 4, and insufficient/inacceptable but repair not possible/reasonable= score 5). Scores of 4 and 5 were considered as failure in the restoration.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Cases with ongoing pulpal symptoms
* Posterior teeth with cusp loss
* Teeth with root canal filling that is at least 2 mm shorter than the radiographic apex
* Individuals unable to attend periodic follow-up visits
* Individuals with a Gingival Index score greater than 1
* Severe periodontal disease
* Presence of systemic diseases
* Individuals with allergic reactions to any of the materials to be used
* Pregnant or breastfeeding women
18 Years
65 Years
ALL
Yes
Sponsors
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Muğla Sıtkı Koçman University
OTHER
Responsible Party
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Fatma Yilmaz
Asistant professor doctor
Locations
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Muğla Sıtkı Koçman University
Menteşe, Muğla, Turkey (Türkiye)
Countries
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References
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Deliperi S, Bardwell DN. Reconstruction of nonvital teeth using direct fiber-reinforced composite resin: a pilot clinical study. J Adhes Dent. 2009 Feb;11(1):71-8.
Meyenberg K. The ideal restoration of endodontically treated teeth - structural and esthetic considerations: a review of the literature and clinical guidelines for the restorative clinician. Eur J Esthet Dent. 2013 Summer;8(2):238-68.
Frater M, Forster A, Kereszturi M, Braunitzer G, Nagy K. In vitro fracture resistance of molar teeth restored with a short fibre-reinforced composite material. J Dent. 2014 Sep;42(9):1143-50. doi: 10.1016/j.jdent.2014.05.004. Epub 2014 May 21.
Carvalho MA, Lazari PC, Gresnigt M, Del Bel Cury AA, Magne P. Current options concerning the endodontically-treated teeth restoration with the adhesive approach. Braz Oral Res. 2018 Oct 18;32(suppl 1):e74. doi: 10.1590/1807-3107bor-2018.vol32.0074.
Yilmaz F, Ozturk Z, Demirbas A, Kursun S. Evaluation of the clinical success of direct restorations of endodontically treated posterior teeth in the presence of parafunction: a 12-month pilot study. Head Face Med. 2025 Oct 10;21(1):70. doi: 10.1186/s13005-025-00546-1.
Other Identifiers
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23/152/02/3/4
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Fiber-reinforced-comp-pilot
Identifier Type: -
Identifier Source: org_study_id
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