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

Clinical Performance Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05808075
• Other study ID #: 27722
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: April 2025

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical Performance

Intervention

Other:
• NovaProTM Fill Universal Dental Composite
NovaProTM Fill Universal ,Nanova product

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomic Form	Modified USPHS criteria United States Public Health Service; USPHS criteria United States Public Health Service	2 years
Secondary	Mechanical, Esthetic and Biological properties	Modified USPHS criteria United States Public Health Service	2 years