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.

Dental Restoration Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05180903
• Other study ID #: Ribbond Reinforced Composite
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: September 10, 2023

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 10, 2023
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Dental Restoration Failure
• Tooth, Nonvital

Intervention

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).

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (14)

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

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. — View 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. — View 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. — View 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. — View Citation

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. Erratum In: Clin Oral Investig. 2021 May;25(5):3339-3340. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the clinical performance	Measured using modified USPHS criteria for clinical evaluation of restoration failure.	Change from the baseline at six months.