Evaluation of the Clinical Performance of Bioactive Giomer Restoration in Class II Cavities After One Year

Evaluation of the Clinical Performance of Bioactive Giomer Restoration in Class II Cavities After One Year and in Vitro Investigation of the Surface Roughness

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06603116

Enrollment

Registered

2024-09-19

Start date

2022-11-15

Completion date

2024-03-25

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Restoration Failure

Keywords

Bioactive Giomer restoration, Nano hybrid composite

Brief summary

Assess the clinical performance of the bioactive Giomer restoration in class II cavities after one year using FDI criteria for assessment of dental restorations. Moreover, the surface roughness will be investigated in-vitro using profilometer

Detailed description

* Patients will be selected according to the following inclusion and exclusion criteria from the outpatient Operative clinic, Faculty of Dental Medicine for Girls, Al-Azhar University. * The patients will be informed about the purpose of the investigation, the clinical procedures and the advantages/risks of the applied materials and techniques. A written informed consent form will be signed from patients prior to study initiation. * Co-operative patients of age range 20-30 years old with no gender prediction, The patients will be divided into two groups Group (1): Bioactive Giomer restoration. Group (2): Nano-hybrid Composite restoration. Restoration will be evaluated using FDI criteria (functional and biological properties) All the restorations will be clinically evaluated after 1 week (baseline),3 month, 6 months,12 months. data collected and statistically analyzed

Interventions

OTHERtreatment of class two cavities

restorations in class 2 cavities

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 30 Years

Healthy volunteers

Yes

Inclusion criteria

* • Each patient should have at least two proximal carious lesions on both sides in the posterior teeth. * Adjacent and opposing natural teeth should be present. * Patient should be willing to return for follow-up examination and evaluation.

Exclusion criteria

* • Patient with poor oral hygiene and motivation. * Patient with unrealistic expectations. * Patients with disabilities, systemic diseases or severe medically compromised, bruxism, clenching or temporomandibular joint disorders and patients with allergy to any components of the materials.

Design outcomes

Primary

Measure	Time frame	Description
evaluation of restorations of class two cavities	from one week to one year	Measured used FDI criteria

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026