Evaluation of Two Different Methods of Resin Composite Application In Class II Restorations

NCT ID: NCT02185573

Last Updated: 2015-10-05

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Three clinical groups will be evaluated. Each group of patients will undergo one method of Resin Composite application (multi-layer technique 'control group' - bulk-fill Technique - Sonicfill technique). The restored teeth will be followed-up till one year. A comparison is going to be made between the three groups in relation to the modified United Sates Public Health Service (USPHS) criteria of good restorations.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The modified USPHS criteria include the evaluation of seven characteristics of the restorations: color match, marginal integrity, surface texture, wear of both restoration and antagonist, recurrent dental caries, fracture or detachment, and gingivitis around the abutment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Class II Dental Restorations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional Technique

Multi-layer filling technique

Group Type NO_INTERVENTION

No interventions assigned to this group

Bulk fill technique

Bulk fill technique

Group Type ACTIVE_COMPARATOR

Bulk fill

Intervention Type PROCEDURE

This is one of the composite restoration application techniques

SonicFill technique

SonicFill technique

Group Type EXPERIMENTAL

SonicFill

Intervention Type PROCEDURE

This is the recent intervention under evaluation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bulk fill

This is one of the composite restoration application techniques

Intervention Type PROCEDURE

SonicFill

This is the recent intervention under evaluation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Cooperated patients.
2. Good general health.
3. Good oral hygiene.
4. Aged 15 to 60 years.
5. Class II restoration (upper or lower)
6. Full erupted teeth.
7. Caries value D3 -D4 according to Daignodent.

Exclusion Criteria

1. If the caries value according to Daignodent is less than D3 -D4.
2. If the tooth is partially erupted.
3. Class II box-like cavity only without any extensions.
4. Patient outside the required age range (15-60 years).
5. Bad oral hygiene.
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Damascus University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rahaf Alkurdi, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

PhD student, Department of Operative Dentistry, University of Damascus Dental School, Damascus

Souad Abboud, DDS MSc PhD

Role: STUDY_DIRECTOR

Associate Professor, Operative Dentistry Department, University of Damascus Dental School, Damascus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Operative Dentistry, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, Syria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Syria

References

Explore related publications, articles, or registry entries linked to this study.

Manhart J, Hickel R. [Bulk-fill-composites. Modern application technique of direct composites for posterior teeth]. Swiss Dent J. 2014;124(1):19-37. doi: 10.61872/sdj-2014-01-02. French, German.

Reference Type BACKGROUND
PMID: 24665478 (View on PubMed)

van Dijken JW, Pallesen U. A randomized controlled three year evaluation of "bulk-filled" posterior resin restorations based on stress decreasing resin technology. Dent Mater. 2014 Sep;30(9):e245-51. doi: 10.1016/j.dental.2014.05.028. Epub 2014 Jun 21.

Reference Type BACKGROUND
PMID: 24958689 (View on PubMed)

Ching K. Deep and fast: Kerr's SonicFill bulk fill composite. HDA Now. 2012 Spring:24-5. No abstract available.

Reference Type BACKGROUND
PMID: 22984718 (View on PubMed)

Furness A, Tadros MY, Looney SW, Rueggeberg FA. Effect of bulk/incremental fill on internal gap formation of bulk-fill composites. J Dent. 2014 Apr;42(4):439-49. doi: 10.1016/j.jdent.2014.01.005. Epub 2014 Jan 27.

Reference Type BACKGROUND
PMID: 24480086 (View on PubMed)

Campos EA, Ardu S, Lefever D, Jasse FF, Bortolotto T, Krejci I. Marginal adaptation of class II cavities restored with bulk-fill composites. J Dent. 2014 May;42(5):575-81. doi: 10.1016/j.jdent.2014.02.007. Epub 2014 Feb 18.

Reference Type BACKGROUND
PMID: 24561041 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UDDS-OperDent-01-2014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Clinical Evaluation of a Bioactive Material
NCT04825379 ACTIVE_NOT_RECRUITING NA