CompletedNCT06603116Updated Sep 19, 2024

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

An interventional study of treatment of class two cavities in Dental Restoration Failure, sponsored by Faculty of Dental Medicine for Girls. Completed at 1 site in Egypt. Open to participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Faculty of Dental Medicine for Girls · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 1 year 10 months after the study started (first participant enrolled Nov 2022, registered Sep 2024).

Phase: Not applicable
Study type: Interventional
Enrollment: 24
Allocation: Randomized
Ages: 20 Years to 30 Years
Sex: All

Study 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

Read the 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

Conditions studied

Dental Restoration Failure

Keywords

Bioactive Giomer restoration
Nano hybrid composite

In context

Lead sponsor

Faculty of Dental Medicine for Girls is the lead sponsor of 52 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 30 Years
Sexes eligible: All
Accepts 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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 24 participants (actual)

Study arms

Experimental
Bioactive Giomer restoration.
material applied according to manufacturer instructions. BEAUTIFIL II LS applied directly into the cavity and create the shape desired in layers not exceeding 2 mm and light cured for 20 seconds
Other: treatment of class two cavities
Active comparator
Nano-hybrid Composite restoration.
applied to the cavity use the conventional incremental technique according to manufacturer instruction
Other: treatment of class two cavities

Interventions

Othertreatment of class two cavities
restorations in class 2 cavities

What researchers measure

Primary outcomes

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

Study locations

1 site

Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt
Cairo, Egypt

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06603116
Lead sponsor: Faculty of Dental Medicine for Girls
Responsible party: Noha Taher (Assistant lecturer at operative department, Faculty of Dental Medicine for Girls) — Principal investigator
First posted: Sep 19, 2024
Start date: Nov 15, 2022
Primary completion: Nov 22, 2022
Completion: Mar 25, 2024
Last update: Sep 19, 2024

Study contacts

Maha Niazy, PHD

study director · Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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