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.

September 24, 2023 updated by: Ahmed Abdelsattar Mohamed Metwaly, Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Faculty of Dentistry, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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.
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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

July 10, 2023

Study Completion (Actual)

September 10, 2023

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

December 17, 2021

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 24, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ribbond Reinforced Composite

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Restoration Failure

Clinical Trials on X-tra base & GrandioSO reinforced by Ribbond

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe