Evaluation of the Clinical Performance of a Bulk Fill Resin Composite in Cuspal Coverage Restorations of Vital Posterior Teeth (RCT)

NCT07612462 | Active Not Recruiting

• 1 other identifier: CUSPALCOVERAGE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study aims to compare bulk-fill and conventional composite resins in cuspal coverage restorations of posterior teeth. The primary outcomes include evaluating wear resistance, fracture incidence, and recurrent caries at different follow-up periods. Bulk-fill composites are designed for easier placement in thicker increments, potentially improving clinical efficiency. The study seeks to determine whether bulk-fill materials can provide comparable or superior performance to conventional composites in restoring structurally compromised teeth.

Conditions

Cusp Capping; Cuspal Coverage; Tooth Restoration; Bulk Fill Composite; Fracture Resistance

Keywords

Cuspal Coverage

Outcome Measures

Primary Outcomes (3)

• Occlusal Wear

  0 = No visible wear 1. = Slight wear, no effect on function 2. = Moderate wear, slight anatomical loss 3. = Severe wear needing intervention

  T0: Baseline examination (1 week after restoration) T1: 6 months T2: 9 months T3: 12 months

• Fracture Resistance

  1. = Restoration fully intact 2. = Partially fractured but retained 3. = Completely fractured or lost

  T0: Baseline examination (1 week after restoration) T1: 6 months T2: 9 months T3: 12 months

• Caries Recurrence

  0 = No recurrent caries at restoration margin 1 = Recurrent caries present and continuous with margin

  T0: Baseline examination (1 week after restoration) T1: 6 months T2: 9 months T3: 12 months

Study Arms (1)

Bulk-Fill Composite Group

ACTIVE COMPARATOR

Participants in this group will receive cuspal coverage restorations using a bulk-fill composite resin. The material will be placed in a single increment following adhesive application according to the manufacturer's instructions.

Device: Beautifil Bulk Fill (Shofu Inc.)

Interventions

Beautifil Bulk Fill (Shofu Inc.) DEVICE

This intervention involves performing cuspal coverage restorations in posterior teeth using Shofu Beautifil Bulk Fill composite resin. The composite will be applied in a single increment following the manufacturer's adhesive and placement protocol. Each restoration will be evaluated clinically for wear resistance, fracture incidence, and recurrent caries during the follow-up period.

Bulk-Fill Composite Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients of 20 to 50 of age
• Molars teeth
• Medically free
• Vital teeth
• Males or females
• one or cusps affected
• Patient consent
• Good oral hygiene (plaque index 0 or 1)
• Absence of parafunctional habits.
• No abscess

You may not qualify if:

• Xerostomia and bruxism.
• Endodontically treated teeth
• Systematic disease
• Extremely poor oral hygiene sever or chronic periodontitis.
• Pregnant and lactating women.
• No subgingival margin
• Allergic to used materials
• Patient are not present during recalls .

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future university in egypt

New Cairo, Cairo Governorate, 11835, Egypt

Location

Related Publications (16)

• Yu P, Xu YX, Liu YS. Polymerization shrinkage and shrinkage stress of bulk-fill and non-bulk-fill resin-based composites. J Dent Sci. 2022 Jul;17(3):1212-1216. doi: 10.1016/j.jds.2021.12.004. Epub 2021 Dec 23.

  PMID: 35784133 RESULT

• Nakhostin A, Panahandeh N, Toudeshky HH, Sheikh-Al-Eslamian SM. Assessment of creep and compressive strength: bulk-fill versus conventional composites. BMC Oral Health. 2025 Apr 16;25(1):579. doi: 10.1186/s12903-025-05769-x.

  PMID: 40240891 RESULT

• Morimoto, S., Lia, W. K. C., Gonçalves, F., Nagase, D. Y., Gimenez, T., Raggio, D. P., & Özcan, M. (2021). Risk Factors Associated with Cusp Fractures in Posterior Permanent Teeth-A Cross-Sectional Study. Applied Sciences, 11(19), 9299.

  RESULT

• Mitra A, Sharma S, Bhattacharyya A, Maity AB, Majumder G, Datta S. The fracture resistance of restored mandibular molars using different cavity designs: An in vitro comparative evaluation. J Conserv Dent Endod. 2024 Dec;27(12):1285-1288. doi: 10.4103/JCDE.JCDE_699_24. Epub 2024 Dec 10.

  PMID: 39959010 RESULT

• Marovic D, Taubock TT, Attin T, Panduric V, Tarle Z. Monomer conversion and shrinkage force kinetics of low-viscosity bulk-fill resin composites. Acta Odontol Scand. 2015 Aug;73(6):474-80. doi: 10.3109/00016357.2014.992810. Epub 2014 Dec 29.

  PMID: 25543454 RESULT

• Manhart, J. (2020). Direct cusp replacement in the molar region using a thermoviscous bulk fill composite restorative material - a clinical case report. International Dental African Edition, 9, 33-22.

  RESULT

• Leprince, J. G. P., W. M.; Vanacker, J.; Sabbagh, J.; Devaux, J. (2020). Polymerization shrinkage and stress of bulk-fill resin composites: A review of the current literature. Journal of Esthetic and Restorative Dentistry, 32(1), 12-22. doi:10.1111/jerd.12511

  RESULT

• Garoushi, S. V., P. K.; Lassila, L. (2021). Fracture resistance of molars with MOD cavities restored with short fiber reinforced composite or bulk fill composites. Journal of Prosthodontic Research, 65(2), 217-233. doi:10.1016/j.jpor.2020.06.004

  RESULT

• Farias-Neto, A. G., L. M.; Silva, L. A. B.; Morimoto, S. (2020). Single-visit direct composite restorations with cuspal coverage: A clinical review. Brazilian Dental Journal, 31(6), 503-509. doi:10.1590/0103-6440202003202

  RESULT

• Edrees, N. S. A. A., H. S. A.; Abdelaziz, K. M.; Alajam, W. (2017). Benefits and drawbacks of bulk-fill dental composites: A systematic review. European Journal of Pharmaceutical and Medical Research, 4(10), 124--137.

  RESULT

• 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 RESULT

• Daruich PM, Brizuela M. Remineralization of Initial Carious Lesions. 2023 Apr 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK573067/

  PMID: 34424640 RESULT

• Chesterman J, Jowett A, Gallacher A, Nixon P. Bulk-fill resin-based composite restorative materials: a review. Br Dent J. 2017 Mar 10;222(5):337-344. doi: 10.1038/sj.bdj.2017.214.

  PMID: 28281590 RESULT

• Alzahrani, F. A. A., I. F.; Aljinbaz, A.; AlZain, F. S. (2021). Effect of cavity design and restoration technique on fracture resistance of premolars restored with resin composites. Operative Dentistry, 46(4), E195-E203. doi:10.2341/20-111-L

  RESULT

• Alshiddi, I. F. A., A.; AlZain, F. S. (2020). Fracture resistance of weakened molars restored with direct and indirect resin-based restorations. Journal of Adhesive Dentistry, 22(1), 72-65. doi:10.3290/j.jad.a43712

  RESULT

• Al-Asmar AA, Al-Hiyasat AS, Abu-Awwad M, Mousa HN, Salim NA, Almadani W, Rihan F, Sawair FA, Pitts NB. Reframing Perceptions in Restorative Dentistry: Evidence-Based Dentistry and Clinical Decision-Making. Int J Dent. 2021 Dec 31;2021:4871385. doi: 10.1155/2021/4871385. eCollection 2021.

  PMID: 35003262 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

EG (1)