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Cusp CappingNCT07612462

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

A study testing Beautifil Bulk Fill (Shofu Inc.) in people with Cusp Capping and Cuspal Coverage, run by Future University in Egypt at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
Cusp Capping, Cuspal Coverage, Tooth Restoration
What is being tested?
Beautifil Bulk Fill (Shofu Inc.)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Dec 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult patients of 20 to 50 of age
  • Molars teeth
  • Medically free
  • Vital teeth
  • Males or females
  • one or cusps affected
Show all 10Show fewer
  • Patient consent
  • Good oral hygiene (plaque index 0 or 1)
  • Absence of parafunctional habits.
  • No abscess

Who cannot join

  • 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 .

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Future university in egypt

    New Cairo, Cairo Governorate, 11835

Other trials in Egypt

About this study

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.

Being tested
Beautifil Bulk Fill (Shofu Inc.)
Keywords
Cuspal Coverage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07612462
Study groupRoleWhat they receive
Bulk-Fill Composite GroupActive comparatorParticipants 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.
Receives: Device: Beautifil Bulk Fill (Shofu Inc.)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occlusal Wear

    0 = No visible wear

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

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

  2. Fracture Resistance

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

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

  3. Caries Recurrence

    0 = No recurrent caries at restoration margin

    1 = Recurrent caries present and continuous with margin

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2026
  2. Study start1 Dec 2025
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07612462
Sponsor's protocol ID
CUSPALCOVERAGE
Status last verified
May 2026
First submitted
21 May 2026
Last updated
28 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35784133

  • 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.

    PubMed 40240891

  • 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.

  • 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.

    PubMed 39959010

  • 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.

    PubMed 25543454

  • 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.

  • 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

  • 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

  • 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

  • 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.

  • 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.

    PubMed 28467261

  • 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/

    PubMed 34424640

  • 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.

    PubMed 28281590

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Beautifil Bulk Fill (Shofu Inc.) in people with Cusp Capping and Cuspal Coverage, run by Future University in Egypt at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occlusal Wear (time frame: T0: Baseline examination (1 week after restoration) T1: 6 months T2: 9 months T3: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07612462, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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