None listed
Conditions
Brief summary
BioUnion Filler is a relatively new restoration material that is known to be the first commercially available bioactive glass-ionomer cement. The manufacturing company recommends using BioUnion Filler in high risk caries patients because of its important characteristic of releasing Zn2+ and Ca2+ in high acidic environment. This study was designed to evaluate the clinical performance of this material in carious cervical lesions by comparing it to GIC (Fuji IX). Information about oral and tooth brushing habits along with gingival bleeding status will be collected for each patient
Interventions
The researcher himself will do the restorations of 40 teeth that will be divided into two groups randomly (20 restorations in each group) and the following will be done in the study group:
- Vitality test (using ethyl chloride on a cotton pellet on the middle third of the facial surface of the tooth)
- Apply local anesthesia
- Isolation with cotton rolls and retraction cords or using rubber dam
- Mechanical preparation and complete caries removal until reaching a clean and caries-free surface
The researcher himself will do the restorations of 40 teeth that will be divided into two groups randomly (20 restorations in each group) and the following will be done in the study group: - Vitality test (using ethyl chloride on a cotton pellet on the middle third of the facial surface of the tooth) - Apply local anesthesia - Isolation with cotton rolls and retraction cords or using rubber dam - Mechanical preparation and complete caries removal until reaching a clean and caries-free surface - Applying glass ionomer cement (GIC) BioUnion Filler (Caredyne-Restore, GC Corporation, Tokyo, Japan) to every cavity in the intervention group and filling the entire cavity until a smooth surface is reached and it is consistent with the original tooth surface - Finishing and polishing after 24 hours follow ups for clinical evaluation of the restorations will be in (3 months, 6 months, 9 months, and 12 moths)
Sponsors
Damascus University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-patient with minimum age 19 - cervical carious lesions (up to 40% of the lesion on root) - lesion depth not less than 1 mm - the lesion must be on: lower or upper molars lower or upper premolars and lower canines only
Exclusion criteria
- history of tooth hypersensitivity - periapical or periodontal diseases - necrotic pulp and endodonticaly treated teeth - previous restorations - bruxism - pregnancy - sensitivity to any material in the study - smokers - using orthodontic appliances
Outcome results
None listed