Performance of GIOMER Based Resin Composite

NCT06021028 | Unknown DMC

• 1 other identifier: Cons2023
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to clinically evaluate the performance of GIOMER based resin composite restorations versus conventional nanohybrid resin composite restorations in complex proximal carious cavities in posterior teeth over 2 years follow up. The null hypothesis will be proposed that there will be no difference in the clinical performance of GIOMER based resin composite restorations versus conventional nanohybrid resin composite restorations in complex proximal carious cavities in posterior teeth over 2 years follow up.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Fracture & retention

  FDI criteria Functional properties

  24 months

Secondary Outcomes (1)

• Rest of FDI criteria

  24 months

Study Arms (2)

Beautifil II Resin composite

EXPERIMENTAL

Giomer restorative

Procedure: complex proximal carious cavities in posterior teeth.

Neo Spectra resin composite

ACTIVE COMPARATOR

Nano-hybrid resin composite

Procedure: complex proximal carious cavities in posterior teeth.

Interventions

complex proximal carious cavities in posterior teeth. PROCEDURE

Selective enamel etching with 37% phosphoric acid for 30 second will be done then the bonding agent will be applied following the manufacturer's instructions.

Beautifil II Resin composite; Neo Spectra resin composite

Eligibility Criteria

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

You may qualify if:

• Patients with proximal carious cavities in molars.
• years.
• Males or Females.
• Good oral hygiene.
• Co-operative patients approving to participate in the study.
• Pulp asymptomatic vital carious complex class II upper or lower posterior teeth.
• The presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

You may not qualify if:

• Poor oral hygiene. Severe medical complications. Pregnancy. Allergic history concerning methacrylates Heavy smoking. Xerostomia. Lack of compliance. Evidence of parafunctional habits Temporomandibular joint disorders.
• Teeth involving more than three surfaces and indicated for indirect restorations.
• Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis. Severe periodontal problems.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mohamed Mohamed sabry Mohamed

Cairo, Nasr City, 11311, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Rawda Hesham Abd ElAziz, Phd

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rawda Hesham Abd ElAziz, Phd

CONTACT

00201001097200; Rawda.hesham@dentistry.cu.edu.eg

Dina Ezzeldin Mohamed, Phd

CONTACT

Dina.ezz@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Conservative dentistry department, Faculty of Dentistry

Model Details: Randomized Parallel Controlled Trial. Trial type: Two, Parallel arm design. Trial framework: Equivalence frame Allocation ratio: 1:1.

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 1, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

EG (1)