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

NCT05808075 | Unknown DMC

• 1 other identifier: 27722
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Clinical Performance

Outcome Measures

Primary Outcomes (1)

• Anatomic Form

  Modified USPHS criteria United States Public Health Service USPHS criteria United States Public Health Service

  2 years

Secondary Outcomes (1)

• Mechanical, Esthetic and Biological properties

  2 years

Study Arms (2)

NovaProTM Fill Universal Dental Composite

EXPERIMENTAL

NovaProTM Fill Universal Dental Composite will be selected , the tooth will be selectively etched with Phosphoric acid gel (37%) to enamel for 30 seconds .The etchant will be removed and the cavity will be rinsed with water spray for 30 seconds and air dried. A uniform thin layer of the adhesive will be applied on all the prepared surfaces then will be dispersed with a stream of air and then light cured. The restorative material will be applied using an incremental filling technique starting at the gingival wall. The restoration will be cured in 2 mm increments for 20 s. The proximal surfaces will be contoured with finishing strips following manufacturer's instructions. The occlusion will be checked with a thin articulating paper and will be adjusted by removing material with a fine diamond or stone. Finishing will be accomplished by finishing diamond stones then polished using rubber points

Other: NovaProTM Fill Universal Dental Composite

Tetric N-Ceram Nano-hybrid Dental Composite

ACTIVE COMPARATOR

The tooth will be selectively etched with N-Etch (IvoclarVivadent, Schaan, Liechtenstein) Phosphoric acid gel (37%) to enamel for 30 seconds. The etchant will be removed and the cavity will be rinsed with water spray for 30 seconds and dried with air syringe. A Uniform thin layer of the adhesive will be applied on all the prepared surface then dispersed with a stream of air and then light cured (Woodpecker Light Cure LED ,China).The restorative material Tetric N-Ceram Nano-hybrid will be applied using an incremental filling technique starting at the gingival wall. Each increment will be polymerized for 20 seconds., Occlusal adjustments will be made using articulating paper. Finishing will be accomplished by finishing diamond then polished using rubber points

Other: NovaProTM Fill Universal Dental Composite

Interventions

NovaProTM Fill Universal Dental Composite OTHER

NovaProTM Fill Universal ,Nanova product

NovaProTM Fill Universal Dental Composite; Tetric N-Ceram Nano-hybrid Dental Composite

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: April 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: April 2025