- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06894186
Comparison of the Functional Properties of Two Injectable Materials in Posterior Teeth: Randomized Clinical Trial
March 24, 2025 updated by: Nourhan elsayed, Future University in Egypt
Using two different injectable materials in class II cavities to compare functional properties
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nourhan Elsayed Abdelrhman, BDS
- Phone Number: 01111001709
- Email: Khalilnourhan1@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 1-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)
Exclusion Criteria:
- 1. 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: beautiful flow plus x
shofu's beauitifil flow plus x is advanced bioactive material with the adaptability of flowable composite and mechanical properities of hybird composite
|
GC Gaenial universal injectable advanced injectable composite with nano sized filler that merge the adaptation of flowable composite and mechanical properties of hybird composite
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Marginal adaptation
Time Frame: T1: 1week T2: 6months T3 12 months
|
T1: 1week T2: 6months T3 12 months
|
|
1- fracture of restoration and retention 2- proximal contact poiont
Time Frame: T(Time) T1:1 week hours beasline T2: 6 months T3:12 months
|
T(Time) T1:1 week hours beasline T2: 6 months T3:12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2025
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
March 19, 2025
First Submitted That Met QC Criteria
March 24, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 24, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Restoring class II cavities
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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