Clinical trial NCT05861908: Bulk-fill With Different Technique Three-year Clinical Performance
Official title: Impact of Placement Techniques on Three-year Clinical Performance of Class II Bulk-fill Resin Composite Restorations and Laboratory Investigation of Marginal Adaptation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bulk-fill Which is Special Type of Resin Composite
Bisphenol A-Glycidyl Methacrylate
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-arm parallel design was followed in this study. There were four group according to placement techniques of bulk-fill resin composite restorations. Each group received 20 restored class II cavities.

All the restorations will be clinically evaluated after 1 week(baseline), 12, 24 and 36 months. Restoration will be evaluated using FDI criteria
Primary purpose: TREATMENT

Brief summary: The current study will be intended to evaluate and compare three-year clinical performance of class II bulk-fill resin composite restorations placed with different techniques.

Detailed description: Fifty patients with proximal carious lesion in permanent molars were included in the study. A total eighty class II cavities were restored with one of the following bulk-fill resin composite with their adhesive systems (n=20) Filtek™ Bulk Fill, Heated Filtek™ Bulk Fill, G-aenial™ BULK Injectable or Sonicfill3. Double blinded randomized clinical trial with survival and clinical quality were evaluated at baseline, after 12 , 24 and 36months using modified FDI(Fédération dentaire internationale) World Dental Federation criteria

Eligibility criteria: Inclusion Criteria:

* Good general health
* Good oral hygienic
* Patient aging 18-35 year
* Patient available for follow-up visits compound class II (mesio-occlusal or disto-occlusal)
* Carious lesion in the external and middle third of dentin thickness
* ICDAS (International caries detection and assessment system) 4 or 5 that diagnosed clinically and radiographically.
* Maxillary or mandibular first or second molars
* Tooth with antagonist and adjacent mesial and distal tooth contact,
* Normal response to a vitality test.

Exclusion Criteria:

* Poor oral hygiene
* Severe or chronic periodontitis
* Heavy bruxism
* Occlusion fewer than 20 teeth
* Sensitivity to resin-based material.
* Patients with orthodontic treatment
* Patients on pregnancy or lactation
* chronic use of anti-inflammatory drugs, analgesic, and/or psychotropic drugs
* Patient potentially unable to attend recall visits
* Teeth would need direct pulp capping or
* Teeth act as abutment for fixed or removable prosthesis.

Primary outcomes:
measure: Esthetic Properties of restorations
timeFrame: Three years Follow up
measure: Functional Properties of restorations
timeFrame: Three years Follow up
measure: Biological Properties of restorations
timeFrame: Three years Follow up
Secondary outcomes:
Other outcomes:
Locations:
city: El Mansura
country: Egypt
facility: Operative Department, Faculty of Dentistry, Mansoura University
state: Daqahlia
Study officials:
References: