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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.

Primary Purpose

Dental Restoration Failure

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
X-tra base & GrandioSO reinforced by Ribbond
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Restoration Failure focused on measuring Ribbond, Reinforced Composite, polyethylene Fibers

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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. -

Sites / Locations

  • Faculty of Dentistry, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bulk Fill resin composite restorations reinforced by ultra high molecular weight polyethylene.

Bulk Fill resin composite restorations

Arm Description

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)

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

Outcomes

Primary Outcome Measures

Change in the clinical performance
Measured using modified USPHS criteria for clinical evaluation of restoration failure.

Secondary Outcome Measures

Full Information

First Posted
December 3, 2021
Last Updated
September 24, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05180903
Brief Title
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.
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
July 10, 2023 (Actual)
Study Completion Date
September 10, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Restoration Failure
Keywords
Ribbond, Reinforced Composite, polyethylene Fibers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bulk Fill resin composite restorations reinforced by ultra high molecular weight polyethylene.
Arm Type
Experimental
Arm Description
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)
Arm Title
Bulk Fill resin composite restorations
Arm Type
Active Comparator
Arm Description
Bulk Fill resin composite restorations (X-tra base & GrandioSO, Voco, Cuxhaven, Germany)
Intervention Type
Other
Intervention Name(s)
X-tra base & GrandioSO reinforced by Ribbond
Other Intervention Name(s)
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)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in the clinical performance
Description
Measured using modified USPHS criteria for clinical evaluation of restoration failure.
Time Frame
Change from the baseline at six months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amira Farid Elzoghbi, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Giza
Country
Egypt

12. IPD Sharing Statement

Citations:
Citation
Abdelaziz Kandil, S. A., M. R. Farid, et al. (2021).
Results Reference
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PubMed Identifier
31559397
Citation
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Results Reference
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PubMed Identifier
19473155
Citation
Ayna B, Celenk S, Atakul F, Uysal E. Three-year clinical evaluation of endodontically treated anterior teeth restored with a polyethylene fibre-reinforced composite. Aust Dent J. 2009 Jun;54(2):136-40. doi: 10.1111/j.1834-7819.2009.01106.x.
Results Reference
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PubMed Identifier
33242913
Citation
Durao MA, Andrade AKM, Santos MDCMDS, Montes MAJR, Monteiro GQM. Clinical Performance of Bulk-Fill Resin Composite Restorations Using the United States Public Health Service and Federation Dentaire Internationale Criteria: A 12-Month Randomized Clinical Trial. Eur J Dent. 2021 May;15(2):179-192. doi: 10.1055/s-0040-1718639. Epub 2020 Nov 26.
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Citation
Deliperi S, Alleman D, Rudo D. Stress-reduced Direct Composites for the Restoration of Structurally Compromised Teeth: Fiber Design According to the "Wallpapering" Technique. Oper Dent. 2017 May/Jun;42(3):233-243. doi: 10.2341/15-289-T.
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Citation
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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.

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