CLINICAL EVALUATION OF BULK-FILL FLOWABLE RESIN-BASED COMPOSITE VERSUS SUBMICRON HYBRID RESIN-BASED COMPOSITE IN CLASS I CARIOUS CAVITIES OVER 18-MONTH: RANDOMIZED CONTROLLED TRIAL.

NCT07575282 | Not Yet Recruiting DMC

• 1 other identifier: BFFCs in Class I cavities
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to evaluate the clinical performance of Bulk-fill flowable resin-based composite versus submicron hybrid resin-based composite restoration in patients with posterior class I carious cavities.

Conditions

Caries Class I

Keywords

bulk fill flowable composite

Outcome Measures

Primary Outcomes (1)

• Clinical performance of the restoration by Modified US Public Health Service Criteria (USPHS).(Mechanical performance) (Anatomic contour).

  18 months

Secondary Outcomes (1)

• Clinical performance of the restoration by Modified US Public Health Service Criteria (USPHS). (Esthetic and sensitivity).

  18 months

Study Arms (2)

control group

ACTIVE COMPARATOR

patients with simple class I cavities to be restored with Submicron hybrid resin- based composite.

Other: Submicron hybrid resin- based composite.

Intervention group

EXPERIMENTAL

patients with simple class I cavities to be restored with Bulk-fill flowable resin-based composite.

Other: Bulk-fill flowable resin-based composite.

Interventions

Bulk-fill flowable resin-based composite. OTHER

patients with simple class I cavities to be restored with Bulk-fill flowable resin-based composite.

Intervention group

Submicron hybrid resin- based composite. OTHER

Patients with simple class I cavities to be restored with Submicron hybrid resin- based composite.

control group

Eligibility Criteria

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

You may qualify if:

• Co-operative patients approving to participate in the trial
• Simple class I carious lesion scored based on the International Caries Detection and Assessment System (ICDAS) is code 2 or 3
• Vital upper or lower molar
• Presence of favorable occlusion.
• Presence of opposing teeth.
• Proper teeth aligment.

You may not qualify if:

• Patients with poor oral hygiene
• Bruxism or occlusion abnormalities.
• Allergic reaction to the materials used.
• Disabilities
• Pregnancy
• Heavy smoking
• Xerostomia
• Lack of Compliance
• TMJ disorders
• Unwillingness or inability to attend follow-ups.
• Deep caries close to pulp.
• Teeth with signs/symptoms of irreversible pulpitis or necrosis.
• Endodontically treated teeth.
• Extensive occlusal destruction
• Periodontal affection

Sponsors & Collaborators

• Cairo University: lead

Related Publications (9)

• Arbildo-Vega HI, Lapinska B, Panda S, Lamas-Lara C, Khan AS, Lukomska-Szymanska M. Clinical Effectiveness of Bulk-Fill and Conventional Resin Composite Restorations: Systematic Review and Meta-Analysis. Polymers (Basel). 2020 Aug 10;12(8):1786. doi: 10.3390/polym12081786.

  PMID: 32785019 BACKGROUND

• Atreja A, Bellam N, Levy SR. Strategies to enhance patient adherence: making it simple. MedGenMed. 2005 Mar 16;7(1):4.

  PMID: 16369309 BACKGROUND

• Vishwanath, V., Rao, M.H. and Prasad, B.K., 2021. Clinical performance of a direct submicron hybrid and indirect zirconium reinforced composite restorations: A 2-year assessment. SRM Journal of Research in Dental Sciences, 12(2), pp.79 85.

  BACKGROUND

• Tyas MJ. Clinical evaluation of glass-ionomer cement restorations. J Appl Oral Sci. 2006;14 Suppl:10-3. doi: 10.1590/s1678-77572006000700003.

  PMID: 19089080 BACKGROUND

• Silva G, Marto CM, Amaro I, Coelho A, Sousa J, Ferreira MM, Francisco I, Vale F, Oliveiros B, Carrilho E, Paula AB. Bulk-Fill Resins versus Conventional Resins: An Umbrella Review. Polymers (Basel). 2023 Jun 8;15(12):2613. doi: 10.3390/polym15122613.

  PMID: 37376259 BACKGROUND

• Parra Gatica E, Duran Ojeda G, Wendler M. Contemporary flowable bulk-fill resin-based composites: a systematic review. Biomater Investig Dent. 2023 Feb 22;10(1):8-19. doi: 10.1080/26415275.2023.2175685. eCollection 2023.

  PMID: 37138762 BACKGROUND

• Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Clin Oral Investig. 2007 Mar;11(1):5-33. doi: 10.1007/s00784-006-0095-7. Epub 2007 Jan 30. Erratum In: Clin Oral Investig. 2008 Mar;12(1):97.

  PMID: 17262225 BACKGROUND

• Canali GD, Ignacio SA, Rached RN, Souza EM. One-year clinical evaluation of bulk-fill flowable vs. regular nanofilled composite in non-carious cervical lesions. Clin Oral Investig. 2019 Feb;23(2):889-897. doi: 10.1007/s00784-018-2509-8. Epub 2018 Jun 12.

  PMID: 29948275 BACKGROUND

• Bayne SC, Schmalz G. Reprinting the classic article on USPHS evaluation methods for measuring the clinical research performance of restorative materials. Clin Oral Investig. 2005 Dec;9(4):209-14. doi: 10.1007/s00784-005-0017-0. No abstract available.

  PMID: 16421996 BACKGROUND

Study Officials

• Rania Sayed Mosallam, professor

  Prof. Dr. Rania Sayed Mosallam

  STUDY DIRECTOR

Central Study Contacts

Huda Mohamed Elsayed Ahmed

CONTACT

00201112099162; huda.elsayed@dentistry.cu.edu.eg

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: Master Candidate

Study Record Dates

• First Submitted: May 2, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05