Clinical Performance of Polyethylene Fiber Reinforced Resin Composite Restorations (Wall Papering Technique) Versus Bulk Fill Resin Composite Restorations in Endodontically Treated Teeth Will be Evaluated Using Modified USPHS Criteria.

Study Overview
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Brief Summary
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The aim of this study will be to evaluate the clinical performance of polyethylene fiber reinforced resin composite restorations versus bulk fill resin composite restorations in endodontically treated teeth.

Detailed Description
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Statement of the problem: Restoration of non-vital teeth is always challenging for dentists. Without placing the coronal restoration, root canal treatments are not considered complete. Appropriate treatment plan selection should be based on remaining tooth structure, cavity wall thickness, tooth position in the arch, and load applied to the tooth. Previously, endodontically treated teeth (ETT) were reconstructed automatically with post, core, and full crown. But this treatment plan had many risks like root perforation, sacrificing a considerable amount of sound tooth structure, and tooth fracture.Several techniques and materials have been developed for the restoration of endodontically treated teeth including complete cast coverage, composite resins and amalgam and indirect restorations covering cusps. Resin-based materials provide rigidity and increase the fracture resistance of non-vital teeth by rein-forcing unsupported tissues. Advanced adhesive systems with improved physical properties are more aesthetic and support remaining tooth structures better than amalgam. In order to reduce polymerization shrinkage stresses, flowable resins with low elastic modulus have been suggested as a stress-absorbing layer under composite restorations. On the other hand, the use of flowable resin does not increase fracture resistance, and this layer results in contraction stresses. Rational: In fact, the primary aims of biomimetic dentistry are to be as minimally invasive as possible, and to substitute the missing hard dental tissues with restorative materials closely resembling the natural tissues regarding their mechanical features and properties. Leno weaved Ultra-high-molecular-weight polyethylene (LWUHMWPE) fibers are plasma treated fibers. LWUHMWPE fiber reinforcement Ribbond systems (Ribbond THM, Ribbond Inc, Seattle, WA, USA) have been introduced in the attempt to increase composite resin toughness, thus increasing both durability and damage tolerance. These bondable reinforcement fibers can be closely adapted to the residual tooth structure without requiring additional preparation. The high modulus of elasticity and low flexural modulus of polyethylene fiber have a modifying effect on the interfacial stresses developed along the cavity walls. According to a systematic review published in 2021 that was done to evaluate various in vitro studies, it was confirmed that the effect of the Ultra-high-molecular weight polyethylene fibers is increasing the fracture resistance and making more favorable fractures in endodontically treated teeth. However, there is no enough clinical data regarding this point, so this proposal is introduced.

Official Title
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Clinical Performance of Polyethylene Fiber Reinforced Resin Composite Restorations (Wall Papering Technique) Versus Bulk Fill Resin Composite Restorations in Endodontically Treated Teeth: A One Year Randomized Clinical Trial

Conditions
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Dental Restoration Failure

Intervention / Treatment
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* Other: X-tra base & GrandioSO reinforced by Ribbond


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant: Patients ages 18 to 55 years. Patients with endodontically treated teeth. Patients with good general health. Patients with good recall availability. Teeth: Successfully endotreated molar teeth. Endodontically treated teeth (ETT) with at least two remaining walls. ETT without apical or periapical pathosis. ETT with healthy peridontium. Exclusion Criteria: Participant; Patients who are allergic to product ingredient. Patients who need indirect restorations. Patients with poor oral hygiene. Patients with history of bruxism and parafunctional habits. Teeth: Teeth with noncarious cervical lesions. ETT with more than two remaining walls. Presence of apical or periapical pathosis. Teeth with advanced periodontal diseases. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bulk Fill resin composite restorations reinforced by ultra high molecular weight polyethylene.<br>Bulk Fill resin composite restorations (X-tra base & GrandioSO, Voco, Cuxhaven, Germany) reinforced by ultra high molecular weight polyethylene. (Ribbond THM, Ribbond Inc, Seattle, WA, USA) | Other: X-tra base & GrandioSO reinforced by Ribbond<br>* The missing peripheral tooth structure will be built up via 2-mm wedge-shaped a universal hybrid resin composite, GrandioSO . Then the polyethylene fibers will be wetted with an unfilled resin first . After removing the excess resin, fibers will be covered with a very thin layer of flowable composite X-tra base . After that, fibers will be bonded immediately against the peripheral missing walls and cured for 20 seconds. Then a bulk-fill flowable resin composite lining X-tra base will be applied in approximately 4 mm thick in bulk increments as needed to fill the cavity 2 mm short of the occlusal cavosurface and each increment will be light cured for 20 s. The remaining occlusal part of the cavity will be restored with a universal hybrid resin composite, GrandioSO . The shade of the composite will be selected according to the teeth to be restored. All cavities will be restored with open-sandwich technique (Deliperi, et al. 2017).<br>* Other names: Bulk Fill resin composite restorations (X-tra base & GrandioSO, Voco, Cuxhaven, Germany) reinforced by ultra high molecular weight polyethylene. (Ribbond THM, Ribbond Inc, Seattle, WA, USA);|
| Active Comparator: Bulk Fill resin composite restorations<br>Bulk Fill resin composite restorations (X-tra base & GrandioSO, Voco, Cuxhaven, Germany) | Other: X-tra base & GrandioSO reinforced by Ribbond<br>* The missing peripheral tooth structure will be built up via 2-mm wedge-shaped a universal hybrid resin composite, GrandioSO . Then the polyethylene fibers will be wetted with an unfilled resin first . After removing the excess resin, fibers will be covered with a very thin layer of flowable composite X-tra base . After that, fibers will be bonded immediately against the peripheral missing walls and cured for 20 seconds. Then a bulk-fill flowable resin composite lining X-tra base will be applied in approximately 4 mm thick in bulk increments as needed to fill the cavity 2 mm short of the occlusal cavosurface and each increment will be light cured for 20 s. The remaining occlusal part of the cavity will be restored with a universal hybrid resin composite, GrandioSO . The shade of the composite will be selected according to the teeth to be restored. All cavities will be restored with open-sandwich technique (Deliperi, et al. 2017).<br>* Other names: Bulk Fill resin composite restorations (X-tra base & GrandioSO, Voco, Cuxhaven, Germany) reinforced by ultra high molecular weight polyethylene. (Ribbond THM, Ribbond Inc, Seattle, WA, USA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the clinical performance | Measured using modified USPHS criteria for clinical evaluation of restoration failure. | Change from the baseline at six months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ribbond, Reinforced Composite, polyethylene Fibers