Clinical trial NCT05808075: Clinical Performance of Nano Fiber Reinforced Versus Conventional Nano Hybrid Composite in Restoring Premolars
Official title: Clinical Performance of Nano Fiber Reinforced Resin Composite Versus Conventional Nano Hybrid Resin Composite in Restoration of Compound Proximal Carious Lesions in Premolar Teeth: Two Years Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clinical Performance
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients that need composite restorations in a compound proximal carious lesions in premolars, will the clinical performance of nano fiber reinforced resin composite restorations have similar results compared to those restored with conventional nano hybrid resin composite over two years follow up period?

Detailed description: The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University outpatient clinic. The operator in charge will be DR. The patients in this study will be selected according to different exclusion and inclusion criteria.

Teeth that meet the inclusion criteria will be selected (n=26) and divided into two groups (n=13).

Group (1): NovaProTM Fill Universal Composite (Nanova Columbia.MO. USA).Group (2): Tetric N-Ceram Nano-hybrid (IvoclarVivadent, Schaan, Liechtenstein). Teeth will be cleaned to remove surface stains. Compound proximal cavities will be prepared with rounded internal angles and with non beveled margins. The carious tissues will be removed using diamond burs of the suitable size at high speed under profuse water cooling system. After the cavity preparation and the appropriate shade of resin material selected, all restorations will be performed using a pre-curved metallic sectional matrix associated with a separating ring and a proper sized wooden wedge to establish the anatomical shape and proximal contacts of the teeth. All the restorative materials will be applied according to the manufacturer instructions (n=13)

All participants will be instructed to follow oral hygiene measures (brush the teeth twice a day, floss once a day) to avoid plaque and bacterial accumulation which may negatively affect the performance.

The restorations will be evaluated at baseline (after placement of restoration), after 6, 12, 18 \& 24 months, using Modified United States Public Health Service criteria (USPHS) for the following characteristics: Anatomic Form (Wear), Marginal integrity, Surface roughness, Marginal discoloration, Color match, Recurrent caries, Post-operative sensitivity. The resin composite restorations will be evaluated with the aid of a dental explorer and an intraoral mirror and visual inspection. The restorations will be scored as follows: Alfa represents the ideal clinical situation, Bravo will be clinically acceptable and Charlie represents a clinically unacceptable situation.

Eligibility criteria: Inclusion Criteria:

* Patient ages 18 to 55 years
* Male or Female patients
* Patients with good oral hygiene
* Patients with good recall availability

Exclusion Criteria:

* Patient who are allergic to products' ingredients used in the study
* Patients with poor oral hygiene
* Patients with history of bruxism and parafunctional habits
* Patients with high caries index or high plaque index.
* Pregnant or lactating women.
* History of severe medical complications such as xerostomia

Primary outcomes:
measure: Anatomic Form
timeFrame: 2 years
Secondary outcomes:
measure: Mechanical, Esthetic and Biological properties
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
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