NCT02763085

Clinical Evaluation of Basic Filling Material in Class I and II Posterior Restorations

Clinical Evaluation of "Basic Filling" Material in Class I and II Cavities: A Prospective Controlled Clinical Trial up to 3 Years

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Istanbul Medipol University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Evaluation of a new basic filling restorative material. In contemporary dentistry, clinicians have essentially three types of material choices for direct restorations: amalgam, resin composite, and glass ionomer restoratives. Due to the toxicity of mercury and the subsequent environmental problems, the search for alternatives continues and search into new composite restorative materials intensifies. Recognized disadvantages of tooth colored resin based restorative materials are as polymerization shrinkage, postoperative sensitivity and technical procedure complexity. Higher rates of occlusal wear and lower toughness are disadvantages of glass ionomer restoratives. Therefore, alternative materials are being developed to compensate the disadvantages of current contemporary tooth coloured restorative materials. Nevertheless, the search for simplification for restoring missing dental tissues introduced the "basic filling concept". This project aims to study the clinical performance of this new basic filling restorative material for Class I and Class II cavities. 80 patients are recruited to the project which is carried out at the School of dentistry, Istanbul Medipol University, Turkey.

Detailed description

The objective of this study is to evaluate the clinical performance of a new basic filling restorative material for Class I and Class II cavities that needs to be restored in permanent teeth. Basic filling material combines the handling properties of glass ionomer restorative materials with the mechanical properties of resin composite restorative materials. Extensive laboratory studies have been performed on the new material, but the clinical attributes have yet to be disclosed. The study will be carried out as a prospective study, with assessment of the restorations after three year. The project includes 80 patients. Most of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. After giving their consent to take part in the study Class I \& II restorations of both upper and lower molars and premolars are performed The treatment procedure is: The patients are offered local anesthetic before treatment start. The cavity is excavated and filled according to the guidelines for composite restorations. The control procedure is: The restoration is evaluated according to marginal adaptation, cavo surface marginal discoloration, approximal contact, fractures, caries associated with restorations and postoperative hypersensitivity. The controls will take place after two weeks, one year, two years and three years.

Conditions

• Caries
• Unsatisfactory Restoration of Tooth

Interventions

Type	Name	Description
DEVICE	Basic Filling Material	Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the materials listed (Basic Filling Material). Procedures will be done using local anesthesia. The cavity is excavated and filled according to the guidelines for ordinary restorative techniques.

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-09-01
• Completion: 2020-11-01
• First posted: 2016-05-05
• Last updated: 2023-04-25

Locations

1 site across 1 country: Turkey (Türkiye)