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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 Will be Evaluated Using Modified USPHS Criteria.

Sponsor
Cairo University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05180903
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
17.3
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: X-tra base & GrandioSO reinforced by Ribbond
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Jul 10, 2023
Anticipated Study Completion Date :
Sep 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bulk Fill resin composite restorations reinforced by ultra high molecular weight polyethylene.

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
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).
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

    Bulk Fill resin composite restorations (X-tra base & GrandioSO, Voco, Cuxhaven, Germany)

    Other: X-tra base & GrandioSO reinforced by Ribbond
    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).
    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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in the clinical performance [Change from the baseline at six months.]

      Measured using modified USPHS criteria for clinical evaluation of restoration failure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Participant:

    1. Patients ages 18 to 55 years.

    2. Patients with endodontically treated teeth.

    3. Patients with good general health.

    4. Patients with good recall availability.

    Teeth:

    1. Successfully endotreated molar teeth.

    2. Endodontically treated teeth (ETT) with at least two remaining walls.

    3. ETT without apical or periapical pathosis.

    4. ETT with healthy peridontium.

    Exclusion Criteria:

    Participant;

    1. Patients who are allergic to product ingredient.

    2. Patients who need indirect restorations.

    3. Patients with poor oral hygiene.

    4. Patients with history of bruxism and parafunctional habits.

    Teeth:

    1. Teeth with noncarious cervical lesions.

    2. ETT with more than two remaining walls.

    3. Presence of apical or periapical pathosis.

    4. Teeth with advanced periodontal diseases. -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry, Cairo University Giza Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Director: Amira Farid Elzoghbi, Professor, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ahmed Abdelsattar Mohamed Metwaly, Assistant Lecturer, Conservative Department, Faculty of Dentistry., Cairo University
    ClinicalTrials.gov Identifier:
    NCT05180903
    Other Study ID Numbers:
    • Ribbond Reinforced Composite
    First Posted:
    Jan 6, 2022
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Ahmed Abdelsattar Mohamed Metwaly, Assistant Lecturer, Conservative Department, Faculty of Dentistry., Cairo University
    Ribbond
    Reinforced Composite
    polyethylene Fibers
    Additional relevant MeSH terms:
    Tooth, Nonvital

    Study Results

    No Results Posted as of Jul 20, 2022