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Bulk-fill With Different Technique Three-year Clinical Performance

Impact of Placement Techniques on Three-year Clinical Performance of Class II Bulk-fill Resin Composite Restorations and Laboratory Investigation of Marginal Adaptation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05861908
Enrollment
50
Registered
2023-05-17
Start date
2021-05-09
Completion date
2024-05-09
Last updated
2023-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bisphenol A-Glycidyl Methacrylate, Bulk-fill Which is Special Type of Resin Composite

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

Interventions

OTHERG-aenial™ BULK Injectable restoration

restoration of class II caries with different bulk-fill technique

OTHERSonicfill3 restoration

restoration of class II caries with different bulk-fill technique

OTHERFiltek™ Bulk Fill restoration

restoration of class II caries with different bulk-fill technique

OTHERHeated Filtek™ Bulk Fill restoration

restoration of class II caries with different bulk-fill technique

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Esthetic Properties of restorationsThree years Follow upcriteria 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 restorationsThree years Follow upcriteria 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 restorationsThree years Follow upcriteria 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026