Clinical Comparison of Composite Materials

Caries; Dentin Clinical Trial

Official title:

Clinical Evaluation of Composite Resins in Class II Cavities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06058026
• Other study ID #: RTEUDHFMKARADAS001
• Status: Completed
• Start date: December 31, 2020
• Est. completion date: September 17, 2022

Study information

• Verified date: February 2024
• Source: Recep Tayyip Erdogan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Universal adhesive solutions have just entered the market, allowing dentists to choose an adhesive strategy based on the needs of patients and clinical situations. Theses adhesives contain a primer/adhesive resin mix in a single bottle for multi-mode etch-and-rinse or self-etch applications. The aim of this study was to evaluate the clinical performance of composite resins with diffent adesive agents on Class II cavities.

Description:

This study was a double-blind (evaluator and patient) randomized controlled clinical study with six study groups with an equal allocation. Two composite materials with two universal and one two-step self-etch adhesives were compared in Class II restorations.

The treated patients were called back for controls after one week, six months, and eighteen months. Restorations were evaluated clinically according to modified FDI criteria. In terms of esthetic property, marginal discoloration; in terms of function properties, fracture and retention, and marginal adaptation; in terms of the biological characteristics, post-operative sensitivity, and secondary caries criteria were examined.

Clinical evaluation was performed by two qualified clinicians. Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 18-month to evaluate the formation of secondary caries.

Differences between adhesives at each time period were evaluated using Fisher's Exact test. The effect of time on restorations was evaluated using the Friedman test (p < 0.05).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 17, 2022
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals without systemic disease

• Individuals with good oral hygiene

• Must be a minimum of one carious defect

• Must be at least 18 years old

• Must have vital teeth in antagonist and proximal contact.

Exclusion Criteria:

• Pregnant or breastfeeding women

• Receiving orthodontic treatment

• Bruxism habit

• Direct or indirect pulp coverage

• Allergy to resin-based products

Related Conditions & MeSH terms

• Caries; Dentin

Intervention

Other:
• World Dental Federation criteria (FDI)
Restorations were evaluated with FDI criteria.

Locations

Country	Name	City	State
Turkey	Muhammet Karadas	Rize	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of class II restorative materials restored with different adhesives	Restored teeth were evaluated according to FDI criteria.	Baseline