An interventional study of Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan) in Dental Caries Class v, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-15.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
The goal of this [type of study: Randomized clinical trial] to compare the clinical performance of using glass ionomer with advanced glass hybrid technology (AGH) in cervical carious lesion, versus Resin modified glass ionomer (RMGI) using esthetic and mechanical properties according to FDI criteria over one year.
in adult patients with cervical carious lesion.
The main question it aims to answer are:
Participants will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept, their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration that will be received after class V cavity preparations for carious cervical lesions.
Patients will be given local anaesthesia (Mepecaine - L Cartridges) as required, and the teeth will be isolated. A No. #330 bur (MANI, INC, Japan) in a high-speed hand piece with air/water coolant will be used to prepare class V cavity. Sharp excavators of suitable size were used to excavate soft carious lesions in dentin. the prepared cavity will be isolated with rubber dam.
The first group (A) will be received resin modified glass ionomer restorative material and the second group (B) will be received advanced glass hybrid glass ionomer . Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline and regular recalls of 6 months and one year. The restorations will be clinically examined according to FDI criteria criteria in terms of esthetic and mechanical properties . The information that will be obtained will be collected and statistically analyzed.
Eligibility criteria
The participants were chosen according to the following eligibility criteria:
Inclusion criteria Exclusion criteria
Patient inclusion:
Tooth inclusion:
Patient exclusion:
Tooth exclusion:
Periapical Abscess or Fistula.
For each recall examination, two independent evaluators will perform the direct clinical evaluation at baseline, after 6 and 12 months using written criteria based on FDI criteria.
Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Patient inclusion:
Tooth inclusion:
Exclusion Criteria:
1. Participants with general/systemic illness. 2. Concomitant participation in another research study. 3. Inability to comply with study procedures. 4. Heavy bruxism habits. 5. Last experience with allergic reactions against any components of the used materials.
6. Patients receiving orthodontic treatment. 7. Teeth supporting removable prosthesis 8. Patients with cervical caries lesions that need crown restoration. 9. Xerostomia.
Tooth exclusion:
Glass Hybrid restorative systems in the clinical point of view are self-cure bulk fill materials laminated with a nano-filled, self-adhesive resin coat. Nowadays, a new glass hybrid innovation called Advanced Glass Hybrid technology was achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass using prefractive indexes.
Drug: Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan)
Drug: Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan)
Advanced Glass Hybrid technology (AGH) was achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass using particles and fillers with close refractive indexes
FDI criteria
Esthetic and mechanical evaluation
Time frame: one year
No study locations are listed for this record.
Plan to share: Yes — international and national publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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