Bulk-fill With Different Technique Three-year Clinical Performance

NCT ID: NCT05861908

Last Updated: 2023-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-09

Study Completion Date

2024-05-09

Brief Summary

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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

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Body Bulk-Fill

20 cavity class II restored with Body bulk-fill Resin composite

Group Type EXPERIMENTAL

Filtek™ Bulk Fill restoration

Intervention Type OTHER

restoration of class II caries with different bulk-fill technique

preheated Bulk-Fill

20 cavity class II restored with preheated bulk-fill Resin composite

Group Type EXPERIMENTAL

Heated Filtek™ Bulk Fill restoration

Intervention Type OTHER

restoration of class II caries with different bulk-fill technique

Injectable Bulk-Fill

20 cavity class II restored with injectable bulk-fill Resin composite

Group Type EXPERIMENTAL

G-aenial™ BULK Injectable restoration

Intervention Type OTHER

restoration of class II caries with different bulk-fill technique

Sonic-Fill

20 cavity class II restored with sonic-fill bulk-fill Resin composite

Group Type EXPERIMENTAL

Sonicfill3 restoration

Intervention Type OTHER

restoration of class II caries with different bulk-fill technique

Interventions

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Filtek™ Bulk Fill restoration

restoration of class II caries with different bulk-fill technique

Intervention Type OTHER

Heated Filtek™ Bulk Fill restoration

restoration of class II caries with different bulk-fill technique

Intervention Type OTHER

G-aenial™ BULK Injectable restoration

restoration of class II caries with different bulk-fill technique

Intervention Type OTHER

Sonicfill3 restoration

restoration of class II caries with different bulk-fill technique

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Operative Department, Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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M01060421

Identifier Type: -

Identifier Source: org_study_id

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