Eighteen Months Clinical Evaluation of Hybrid Ceramic Inlays Cemented with Giomer Based Self-adhesive Resin Cement Versus Resin-based Cement in Carious Posterior Teeth: Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 50
- Primary Endpoint
- Clinical Performance assessing Biological, Mechanical and Esthetic Parameters Using Modified USPHS Criteria
Study Overview
Brief Summary
Minimally invasive bonded partial restorations have become a crucial component of contemporary dental treatments. They address the shortcomings of direct restorations and provide patients with a less damaging alternative to full coverage restorations, which can be more harmful to the dental structure. Indirect inlay composite restorations have become a popular choice in restorative dentistry due to their aesthetic appeal and durability. These restorations allow for the preservation of tooth structure while utilizing the mechanical advantages of modern adhesive technology, which can reinforce the weakened compromised tooth structure.
The use of different adhesive materials with Ceramage can significantly influence the success of the restoration. Adhesive materials play a crucial role in ensuring a strong bond between the indirect restoration and the tooth structure. Additionally, the choice of adhesive material can also affect the ease of the cementation process. Self-adhesive resin cement simplifies the procedure by eliminating the need for separate bonding agents, thus reducing the risk of technique sensitivity which can lead to more consistent clinical outcomes and improved patient satisfaction.
Overall, the combination of Ceramage with appropriate adhesive materials offers a reliable and aesthetically pleasing solution for indirect inlay composite restorations, enhancing both the biological, functional and esthetic outcomes of dental treatments.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Posterior vital tooth with a large carious lesion (ICDAS 4/5)
- •Posterior vital tooth with a broken restoration that should be replaced (ICDAS 4-7/5-7).
- •Vital, periodontally sound and with positive reaction to cold stimulus.
- •Fully erupted posterior molar in normal functional occlusion with natural antagonist and adjacent teeth.
Exclusion Criteria
- •Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- •Non-vital teeth, Fractured or cracked teeth.
- •Endodontically treated teeth.
- •Periodontally affected teeth.
Arms & Interventions
Cementation via Beautilink SA cement
Ceramage inlays will be cemented using Beautilink SA cement
- To enhance the adhesion, adhesive bonding agent BeautiBond Xtreme, Shofu will be applied on the tooth and cured according to the manufacturer's instructions.
- Press the plunger of the auto-mix syringe of Beautilink SA to dispence the cement on the adhesive surface of the restoration.
- Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 5 minutes after light-curing to allow for chemical curing.
Intervention: Beautilink SA cement (Other)
Cementation via RelyX resin cement
Ceramage inlays will be cemented using RelyX resin cement
- To enhance the adhesion, adhesive bonding agent 3M™ Scotchbond™ Universal Plus Adhesive will be applied on the tooth and cured according to the manufacturer's instructions.
- Application of 3M™RelyX™ Universal Resin Cement into the cavity
- Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 6 minutes after light-curing to allow for chemical curing.
Intervention: RelyX resin cement (Other)
Outcomes
Primary Outcomes
Clinical Performance assessing Biological, Mechanical and Esthetic Parameters Using Modified USPHS Criteria
Time Frame: T0: 12 months T1: 18 months
Alpha being the best results and Charlie being the worst results
Secondary Outcomes
No secondary outcomes reported
Investigators
Mariam Mohamed Ahmed Gomaa
MSc. 2024, Faculty of Dentistry, Cairo University
Cairo University