Class V Dental Caries, Type 2 Diabetes Mellitus, Giomer Technology; Injectable Resin Composite; Zirconia-Modified Glass Ionomer
Conditions
Brief summary
This randomized controlled clinical trial aims to compare the clinical performance of zirconia-reinforced glass ionomer and injectable giomer restorations in Class V carious lesions among controlled type II diabetic against non-diabetics. One hundred Class V restorations will be allocated equally into four parallel groups according to restorative material and diabetic status. Clinical performance will be evaluated at baseline, 6, 12, and 18 months using the modified United States Public Health Service (USPHS) criteria. The primary outcome is restoration retention, while secondary outcomes include marginal adaptation, marginal discoloration, secondary caries, and postoperative sensitivity.
Interventions
OTHERZirconomer
Zirconia-reinforced glass ionomer restorative material (SHOFU)
Injectable giomer restorative material incorporating S-PRG technology (SHOFU)
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male or Female participants from 22 to 55 years * Controlled diabetic and non-diabetic patients consulting the outpatient clinic * Patients categorized as moderate or high caries risk * Patients willing to provide informed consent * Co-operative patients agreeing to participate in the trial Inclusion Criteria for teeth * Teeth with class V carious lesion classified according to the International Caries Detection and Assessment System (ICDAS II) as ICDAS code (4) or ICDAS code (5) * Teeth with normal pulp vitality testing; no signs of inflammation or spontaneous pain before treatment
Exclusion criteria
* Patients with spontaneous or elicited pain from caries. * Systemic illnesses other than diabetes. * Severe bruxism/clenching. * Temporomandibular joint disorders. * Inability to return for recall visits/ Refusal to participate in the study. * Pregnancy. * heavy smoking. * Lack of compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Restoration Retention | Baseline, 6 months, 12 months, and 18 months | Restoration retention assessed using the modified USPHS criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marginal adaptation | Baseline, 6 months, 12 months, and 18 months | Using Modified USPHS Criteria |
| Marginal discoloration | Baseline, 6 months, 12 months and 18 months | Using Modified USPHS Criteria |
| Secondary caries | Baseline, 6 months, 12 months and 18 months. | Using Modified USPHS Criteria |
| Postoperative sensitivity | Baseline, 6 months, 12 months and 18 months. | Using Modified USPHS Criteria |
Contacts
CONTACTMohamed Ayman Hamdy Ayman
Outcome results
None listed