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.

NCT05180903 | Completed

• 1 other identifier: Ribbond Reinforced Composite
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Restoration Failure

Keywords

Ribbond; Reinforced Composite; polyethylene Fibers

Outcome Measures

Primary Outcomes (1)

• Change in the clinical performance

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

  Change from the baseline at six months.

Study Arms (2)

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

EXPERIMENTAL

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

Bulk Fill resin composite restorations

ACTIVE COMPARATOR

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

Other: X-tra base & GrandioSO reinforced by Ribbond

Interventions

X-tra base & GrandioSO reinforced by Ribbond OTHER

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).

Also known as: 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; Bulk Fill resin composite restorations reinforced by ultra high molecular weight polyethylene.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Giza, Egypt

Location

Related Publications (15)

• Abdelaziz Kandil, S. A., M. R. Farid, et al. (2021).

  BACKGROUND

• Atlas A, Grandini S, Martignoni M. Evidence-based treatment planning for the restoration of endodontically treated single teeth: importance of coronal seal, post vs no post, and indirect vs direct restoration. Quintessence Int. 2019;50(10):772-781. doi: 10.3290/j.qi.a43235.

  PMID: 31559397 BACKGROUND

• 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.

  PMID: 19473155 BACKGROUND

• 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.

  PMID: 33242913 BACKGROUND

• 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.

  PMID: 28467261 BACKGROUND

• Frater M, Lassila L, Braunitzer G, Vallittu PK, Garoushi S. Fracture resistance and marginal gap formation of post-core restorations: influence of different fiber-reinforced composites. Clin Oral Investig. 2020 Jan;24(1):265-276. doi: 10.1007/s00784-019-02902-3. Epub 2019 May 16.

  PMID: 31098711 BACKGROUND

• Garoushi S, Gargoum A, Vallittu PK, Lassila L. Short fiber-reinforced composite restorations: A review of the current literature. J Investig Clin Dent. 2018 Aug;9(3):e12330. doi: 10.1111/jicd.12330. Epub 2018 Feb 25.

  PMID: 29479830 BACKGROUND

• Karaman E, Keskin B, Inan U. Three-year clinical evaluation of class II posterior composite restorations placed with different techniques and flowable composite linings in endodontically treated teeth. Clin Oral Investig. 2017 Mar;21(2):709-716. doi: 10.1007/s00784-016-1940-y. Epub 2016 Aug 19.

  PMID: 27538739 BACKGROUND

• Kashi, A. M. A., S. Ghanbaran, et al. (2020).

  BACKGROUND

• Lempel E, Lovasz BV, Bihari E, Krajczar K, Jeges S, Toth A, Szalma J. Long-term clinical evaluation of direct resin composite restorations in vital vs. endodontically treated posterior teeth - Retrospective study up to 13 years. Dent Mater. 2019 Sep;35(9):1308-1318. doi: 10.1016/j.dental.2019.06.002. Epub 2019 Jul 2.

  PMID: 31278018 BACKGROUND

• Ozsevik AS, Yildirim C, Aydin U, Culha E, Surmelioglu D. Effect of fibre-reinforced composite on the fracture resistance of endodontically treated teeth. Aust Endod J. 2016 Aug;42(2):82-7. doi: 10.1111/aej.12136. Epub 2015 Nov 27.

  PMID: 26611674 BACKGROUND

• Shah EH, Shetty P, Aggarwal S, Sawant S, Shinde R, Bhol R. Effect of fibre-reinforced composite as a post-obturation restorative material on fracture resistance of endodontically treated teeth: A systematic review. Saudi Dent J. 2021 Nov;33(7):363-369. doi: 10.1016/j.sdentj.2021.07.006. Epub 2021 Jul 14.

  PMID: 34803275 BACKGROUND

• Valizadeh S, Ranjbar Omrani L, Deliperi S, Sadeghi Mahounak F. Restoration of a Nonvital Tooth with Fiber Reinforce Composite (Wallpapering Technique). Case Rep Dent. 2020 Jun 5;2020:9619787. doi: 10.1155/2020/9619787. eCollection 2020.

  PMID: 32566326 BACKGROUND

• Wang X, Shu X, Zhang Y, Yang B, Jian Y, Zhao K. Evaluation of fiber posts vs metal posts for restoring severely damaged endodontically treated teeth: a systematic review and meta-analysis. Quintessence Int. 2019;50(1):8-20. doi: 10.3290/j.qi.a41499.

  PMID: 30600326 BACKGROUND

• Metwaly AA, Elzoghby AF, Abd ElAziz RH. Clinical performance of polyethylenefiber reinforced resin composite restorations in endodontically treated teeth: (a randomized controlled clinical trial). BMC Oral Health. 2024 Oct 24;24(1):1285. doi: 10.1186/s12903-024-05009-8.

  PMID: 39448991 DERIVED

Study Officials

• Amira Farid Elzoghbi, Professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer, Conservative Department, Faculty of Dentistry.

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: January 6, 2022
• Study Start: April 1, 2022
• Primary Completion: July 10, 2023
• Study Completion: September 10, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

EG (1)