Clinical trial NCT03283280: Clinical Performance of Short Fiber Reinforced Resin Composite Versus Indirect Nanohybrid Resin Composite Onlay Restorations.
Official title: Clinical Performance of Short Fiber Reinforced Resin Composite Restorations Versus Indirect Nanohybrid Resin Composite Onlay Restorations in Complex Proximal Cavities of Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Restoration Failure of Marginal Integrity
Keywords: Short fiber reinforced resin composite
Nanohybrid resin composite
Indirect resin composite restoration
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 76
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: clinical performance of short fiber reinforced resin composite versus indirect nanohybrid resin composite onlay restorations in complex proximal cavities of molar teeth will be evaluated over one year.

Detailed description: Resin composite materials have been rapidly developed in the latest few years. Direct resin composite restorations become the golden standard for restoring intracoronal cavities. While for the extracoronal cavities, the indirect resin composite onlays tend to replace metallic restorations in most situations being more esthetic and conservative with lower cost (Rocca \& Krejci, 2007).

Indirect resin composite onlays usually are lab processed in two appointments but it can be made in one appointment through CAD/CAM technology or by flexible model technique (semidirect technique).

These restorations offer more control on the proximal contacts and the anatomic form over the direct approach. Polymerization shrinkage occurs outside the patient mouth so the stresses are decreased and become limited to the width of the luting space. Annual failure rate (AFR) of indirect posterior resin composite restorations is up to 10% (Manhart et al, 2004).

One of the advancement in resin composite technology is the evolution of short fiber reinforced resin composite (SFRC) material that allows making a direct onlay restoration possible thus offers less procedural steps and saves more time (Garoushi et al, 2013).

This material is made to be used as a dentine substitute in the high stress-bearing areas. It is covered by a conventional resin composite filling to act as the enamel replacement this combination gives us a kind of biomimetic restoration.

Eligibility criteria: Inclusion Criteria

1. Pulp asymptomatic vital carious upper or lower molars.
2. Proximal complex carious cavities involving one or two weak cusps.
3. Replacement of old amalgam or resin composite restoration due to recurrent caries or either tooth or restoration fracture.
4. Presence of favorable occlusion.
5. Healthy volunteers

Exclusion Criteria:

1. Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
2. Deep subgingival cavity margins.
3. Possible future prosthodontic restoration of teeth.
4. Severe periodontal problems.
5. Medically compromised patients.

Primary outcomes:
measure: Change in the Clinical performance
timeFrame: Change from the Baseline at six months and 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Assistant lecturer
name: Rawda Hesham Abd ElAziz, Msc
role: PRINCIPAL_INVESTIGATOR
References: