NCT06894186

Brief Summary

Using two different injectable materials in class II cavities to compare functional properties

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

March 19, 2025

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Marginal adaptation

    T1: 1week T2: 6months T3 12 months

  • 1- fracture of restoration and retention 2- proximal contact poiont

    T(Time) T1:1 week hours beasline T2: 6 months T3:12 months

Study Arms (1)

beautiful flow plus x

EXPERIMENTAL

shofu's beauitifil flow plus x is advanced bioactive material with the adaptability of flowable composite and mechanical properities of hybird composite

Other: Gaenial universal injectable

Interventions

GC Gaenial universal injectable advanced injectable composite with nano sized filler that merge the adaptation of flowable composite and mechanical properties of hybird composite

beautiful flow plus x

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients (20-50) 2-Good oral hygiene Good oral hygiene (Plaque index ≤2 (Moderate accumulation with plaque in the sulcus)) 3-Patient approval 4-Absence of parafunctional habits and/or bruxism 5-No endodontic treatment or abscess 6- class II either mesial or distal (no MOD cavities)

You may not qualify if:

  • \. Systematic disease that may affect participation. 2. Xerostomic patients. 3. Bad oral hygiene (plaque index 2 or 3) 14 4. Heavy smokers 5. Patients undergoing or will start orthodontic treatment 6. Signs and symptoms of irreversible pulpitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Hancer Sarica S, Arslan S, Balkaya H. Comparison of the 2-year clinical performances of class II restorations using different restorative materials. Clin Oral Investig. 2025 Feb 13;29(2):128. doi: 10.1007/s00784-025-06207-6.

  • Elderiny HM, Khallaf YS, Akah MM, Hassanein OE. Clinical Evaluation of Bioactive Injectable Resin Composite vs Conventional Nanohybrid Composite in Posterior Restorations: An 18-Month Randomized Controlled Clinical Trial. J Contemp Dent Pract. 2024 Aug 1;25(8):794-802. doi: 10.5005/jp-journals-10024-3737.

  • Rajabi H, Denny M, Karagiannopoulos K, Petridis H. Comparison of Flexural Strength and Wear of Injectable, Flowable and Paste Composite Resins. Materials (Basel). 2024 Sep 27;17(19):4749. doi: 10.3390/ma17194749.

  • Neto CCL, das Neves AM, Arantes DC, Sa TCM, Yamauti M, de Magalhaes CS, Abreu LG, Moreira AN. Evaluation of the clinical performance of GIOMERs and comparison with other conventional restorative materials in permanent teeth: a systematic review and meta-analysis. Evid Based Dent. 2022 Aug 1. doi: 10.1038/s41432-022-0281-8. Online ahead of print.

  • Ozer F, Patel R, Yip J, Yakymiv O, Saleh N, Blatz MB. Five-year clinical performance of two fluoride-releasing giomer resin materials in occlusal restorations. J Esthet Restor Dent. 2022 Dec;34(8):1213-1220. doi: 10.1111/jerd.12948. Epub 2022 Aug 7.

  • Deepika U, Sahoo PK, Dash JK, Baliarsingh RR, Ray P, Sharma G. Clinical evaluation of bioactive resin-modified glass ionomer and giomer in restoring primary molars: A randomized, parallel-group, and split-mouth controlled clinical study. J Indian Soc Pedod Prev Dent. 2022 Jul-Sep;40(3):288-296. doi: 10.4103/jisppd.jisppd_139_22.

  • 2022. Flowable GIOMER Vs Conventional Flowable Composite For Retention And Prevention Of Caries Recurrence When Used As Sealants For Initially Demineralized Fissures. A Randomized Clinical Trial. Journal of Pharmaceutical Negative Results. (Nov. 2022), 3257 3263

    RESULT
  • Badr C, Spagnuolo G, Amenta F, Khairallah C, Mahdi SS, Daher E, Battineni G, Baba NZ, Zogheib T, Qasim SSB, Daher T, Chintalapudi N, Zogheib CM. A Two-Year Comparative Evaluation of Clinical Performance of a Nanohybrid Composite Resin to a Flowable Composite Resin. J Funct Biomater. 2021 Sep 9;12(3):51. doi: 10.3390/jfb12030051.

  • Kitasako Y, Sadr A, Burrow MF, Tagami J. Thirty-six month clinical evaluation of a highly filled flowable composite for direct posterior restorations. Aust Dent J. 2016 Sep;61(3):366-73. doi: 10.1111/adj.12387.

  • Kramer N, Reinelt C, Frankenberger R. Ten-year Clinical Performance of Posterior Resin Composite Restorations. J Adhes Dent. 2015 Aug;17(5):433-41. doi: 10.3290/j.jad.a35010.

  • Bayraktar Y, Ercan E, Hamidi MM, Colak H. One-year clinical evaluation of different types of bulk-fill composites. J Investig Clin Dent. 2017 May;8(2). doi: 10.1111/jicd.12210. Epub 2016 Jan 22.

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

Nourhan Elsayed Abdelrhman, BDS

CONTACT

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

March 19, 2025

First Posted

March 25, 2025

Study Start

March 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

March 25, 2025

Record last verified: 2025-03