Clinical Performance of Nano Fiber Reinforced Versus Conventional Nano Hybrid Composite in Restoring Premolars

Not Applicable

Not yet recruiting

• Conditions: Clinical Performance

• Registration Number: NCT05808075
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Study Start: 2023-04
• Study First Posted: 2023-04-11
• Last Update Posted: 2023-04-11
• Primary Completion: 2024-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anatomic Form	2 years	Modified USPHS criteria United States Public Health Service; USPHS criteria United States Public Health Service

Secondary Outcome Measures

Name	Time	Method
Mechanical, Esthetic and Biological properties	2 years	Modified USPHS criteria United States Public Health Service