Bulk-fill With Different Technique Three-year Clinical Performance

Not Applicable

Active, not recruiting

• Conditions: Bisphenol A-Glycidyl Methacrylate; Bulk-fill Which is Special Type of Resin Composite
• Interventions: Other: Filtek™ Bulk Fill restoration; Other: Sonicfill3 restoration; Other: Heated Filtek™ Bulk Fill restoration; Other: G-aenial™ BULK Injectable restoration

• Registration Number: NCT05861908
• Lead Sponsor: Mansoura University

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

Study Timeline

• Study Start: 2021-05-09
• Primary Completion: 2022-05-09
• Status Verified: 2023-03
• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-05-16
• Last Update Submitted: 2023-05-16
• Study First Posted: 2023-05-17
• Last Update Posted: 2023-05-17
• Study Completion: 2024-05-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Body Bulk-Fill	Filtek™ Bulk Fill restoration	20 cavity class II restored with Body bulk-fill Resin composite
Sonic-Fill	Sonicfill3 restoration	20 cavity class II restored with sonic-fill bulk-fill Resin composite
preheated Bulk-Fill	Heated Filtek™ Bulk Fill restoration	20 cavity class II restored with preheated bulk-fill Resin composite
Injectable Bulk-Fill	G-aenial™ BULK Injectable restoration	20 cavity class II restored with injectable bulk-fill Resin composite

Primary Outcome Measures

Name	Time	Method
Esthetic Properties of restorations	Three years Follow up	criteria that evaluated according to Modified FDI(International Dental Federation) world dental federation is: 1. Surface luster; 2. Staining; 3. Color match and translucency; 4. Esthetic and Anatomic form; Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor
Functional Properties of restorations	Three years Follow up	criteria that evaluated according to Modified FDI (International Dental Federation) world dental federation is: 1. Fractures of material and retention; 2. Marginal adaptation; 3. Occlusal contour and wear; 4. Proximal anatomical form; 5. Patient's view; Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor
Biological Properties of restorations	Three years Follow up	criteria that evaluated according to Modified FDI (International Dental Federation) world dental federation is: 1. Post-operative (hyper-sensitivity) and tooth vitality; 2. Recurrence of caries, erosion, abfraction; 3. Tooth integrity (enamel cracks, tooth fractures); 4. Periodontal; 5. Adjacent Mucosa; 6. Oral and General Health; Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor

Trial Locations

Locations (1)

Operative Department, Faculty of Dentistry, Mansoura University; 🇪🇬 El Mansura, Daqahlia, Egypt