Performance of GIOMER Based Resin Composite Restorations Versus Conventional Nanohybrid Resin Composite Restorations in Complex Proximal Carious Cavities in Posterior Teeth. (A 24-month Randomized Clinical Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Fracture & retention
Study Overview
Brief Summary
The aim of the study is to clinically evaluate the performance of GIOMER based resin composite restorations versus conventional nanohybrid resin composite restorations in complex proximal carious cavities in posterior teeth over 2 years follow up. The null hypothesis will be proposed that there will be no difference in the clinical performance of GIOMER based resin composite restorations versus conventional nanohybrid resin composite restorations in complex proximal carious cavities in posterior teeth over 2 years follow up.
Detailed Description
Scientific background:
One of the advancements in resin composite technology to support its use as a bioactive material, is the evolution of GIOMER based resin composite material which has an added benefit of sustained fluoride and other ions release and rechargeability. A distinguishing feature of the "giomer" class of restorative materials is the stable surface prereacted glass core (sPRG) that is lined with an ionomer in a resin matrix. This configuration enables the glass core to be protected from moisture, giving it long term aesthetics and the durability of conventional resin composites with ion release and recharge1. When evaluating the clinical performance of low shrinkage giomer based resin composite (Beautifil II LS; Shofu Inc.) compared with a conventional nanohybrid resin composite in class I and class II cavities, It was found that in both groups, according to FDI criteria, the restorations were mostly rated with best scores (Score 1 or 2) regarding the biological, functional, and optical parameters 2. Also, after five years of clinical performance, both the nano-hybrid giomer restorative materials flowable giomer (Beautifil Flow Plus F00; Shofu Inc.) and the conventional nano-hybrid giomer restorative material (Beautifil II; Shofu Inc.) were comparably acceptable and not significantly different for any of the parameters evaluated in occlusal cavities 3. Meanwhile in a recent systematic review, it was concluded that GIOMER based resin composites showed similar clinical performance concerning marginal adaptation and better surface roughness when compared to Resin-modified glass ionomer cement 4.
Statement of the problem:
The survival rate for resin-based composite restorations declined to roughly 85-90% after ten years. Bulk fractures and wear, which accounted for about 70% of replacements, were the main causes of restorative replacement. About 20% of the resin-based restorations were replaced because of caries at the margins of the restorations, and 10% were due to retention loss, poor color matching, poor marginal integrity, endodontic therapy, or cusp fracture 5. These failures are correlated mainly with patient risk profile i.e., caries risk , presence of parafunctional habits and those with high number of restored surfaces (complex cavities) 6.
Rationale:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Triple (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inclusion Criteria of participants:
- •Patients with proximal carious cavities in molars.
- •18 - 50 years.
- •Males or Females.
- •Good oral hygiene.
- •Co-operative patients approving to participate in the study.
- •Inclusion Criteria of teeth:
- •Pulp asymptomatic vital carious complex class II upper or lower posterior teeth.
- •The presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
Exclusion Criteria
- •Exclusion criteria of participants:
- •Poor oral hygiene. Severe medical complications. Pregnancy. Allergic history concerning methacrylates Heavy smoking. Xerostomia. Lack of compliance. Evidence of parafunctional habits Temporomandibular joint disorders.
- •Exclusion criteria of the teeth:
- •Teeth involving more than three surfaces and indicated for indirect restorations.
- •Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis. Severe periodontal problems.
Arms & Interventions
Beautifil II Resin composite
Giomer restorative
Intervention: complex proximal carious cavities in posterior teeth. (Procedure)
Neo Spectra resin composite
Nano-hybrid resin composite
Intervention: complex proximal carious cavities in posterior teeth. (Procedure)
Outcomes
Primary Outcomes
Fracture & retention
Time Frame: 24 months
FDI criteria Functional properties
Secondary Outcomes
- Rest of FDI criteria(24 months)
Investigators
Rawda Hesham Abd ElAziz
Lecturer, Conservative dentistry department, Faculty of Dentistry
Cairo University