Clinical trial NCT06212141: Comparison of Bulk-Fill Composite Resins in Class II Restorations
Official title: Clinical Comparison of Convetional Bulk-Fill Composite Resins and Thermoviscous Bulk-Fill Composite Resins in Class II Restorations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Class II Dental Caries
Keywords: Bulk-Fill Composite
Thermoviscous Bulk-Fill Composite
Class II Restorations
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized split-mouth clinical trial
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the clinical performance of Class II restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins .

Class II restorations will be performed in patients using three different restorative materials.And restorations will be evaluated using modified US Public Health Service criteria Resorations will be photograped and restorations will be evaluated for 6,12 months.

Detailed description: The aim of this clinical study was to evaluate the clinical performance of Class II restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins.

Methods and Materials: Class II restorations will be performed in patients using three different restorative materials: VisCalor Thermoviscous Bulk-Fill (VCB; a thermoviscous nanohybrid bulk-fill composite resin) , Admira Fusion x-tra ( AFT: a conventional nanohybrid bulk-fill composite resin) and 3M Filtek One Bulk-Fill Restprative (FOB: a conventional bulk-fill nanocomposite ) Futura Bond U adhesive will be used for both conventional bulk-fill composite resin restorations and thermoviscous bulk-fill composite resin restorations.

Criteria for inclusion of patients in the study : Healthy individuals without any systemic disease, patients who is between 18 and 60 years old, patiens who brush their teeth 2 times a day,voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment.

Criteria for not inclusion of volunteers in research:Women who are pregnant or breastfeeding ,patienrs with advanced periodontial disease,patiens using a moving segmental prosthesis,patiens who have maloclusions,patiens who have bruxism,patients with known allergies to resin-based restorative materials and binding agents

The restorations will be evaluated using modified US Public Health Service criteria in terms of retention, color match, marginal discoloration, anatomic form, marginal adaptation, secondary caries, postoperative sensitivity, and surface texture. Resorations will be photograped and restorations will be evaluated for 6,12 months

.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals without any systemic disease
* Patients who is between 18 and 60 years old,
* Patiens who brush their teeth 2 times a day
* Voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment.

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Patients with advanced periodontial disease
* Patiens using a moving segmental prosthesis
* Patiens who have maloclusions,
* Patiens who have bruxism,
* Patients with known allergies to resin-based restorative materials and binding agents

Primary outcomes:
measure: Marginal Adaptation
timeFrame: From baseline to 18 month
measure: Marginal Staining
timeFrame: From baseline to 18 month
measure: Retention
timeFrame: From baseline to 18 month
measure: Seconder caries
timeFrame: From baseline to 18 month
measure: Postoperative sensitivity
timeFrame: From baseline to 18 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Nurdan Meserret Başeren, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chesterman J, Jowett A, Gallacher A, Nixon P. Bulk-fill resin-based composite restorative materials: a review. Br Dent J. 2017 Mar 10;222(5):337-344. doi: 10.1038/sj.bdj.2017.214.