Class II Dental RestorationsNCT02185573

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

A study testing Bulk fill and SonicFill in people with Class II Dental Restorations, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 to 60 years
Conditions the study is for: Class II Dental Restorations
What is being tested?: Bulk fill and SonicFill
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteSyria
Study dates: Jul 2014to Oct 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 60 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Syria1 site

Department of Operative Dentistry, University of Damascus Dental School
Damascus, Rif-dimashq Governorate, DM20AM18

Other trials in Syria

About this study

Official title: Evaluation of Two Different Methods of Resin Composite Application Using Bulk-fill Technique In Class II Restorations

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.

Read the detailed description

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: Class II Dental Restorations
Being tested: Bulk fill, SonicFill
Keywords: Bulk fill, SonicFill, resin composite application, class II restoration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bulk fillProcedure or surgery
This is one of the composite restoration application techniques
SonicFillProcedure or surgery
This is the recent intervention under evaluation

Study groups in NCT02185573
Study group	Role	What they receive
Conventional Technique	No intervention	Multi-layer filling technique
Bulk fill technique	Active comparator	Bulk fill technique Receives: Procedure: Bulk fill
SonicFill technique	Experimental	SonicFill technique Receives: Procedure: SonicFill

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Color Match
Color match
1. The restoration appears to match the shade and translucency of adjacent tooth tissues.
2. The restoration does not match the shade and translucency of adjacent tooth tissues, but the mismatch is within the range of tooth shade.
3. The restoration does not match the shade and translucency of adjacent tooth tissues, and the mismatch is outside the normal range of tooth shade and translucency.
Measured: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Change in Marginal Integrity
Marginal integrity
1. The explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does catch, there is no visible crevice along the periphery of the restoration.
2. The explorer catches and there is visible evidence of crevice, into which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure.
3. the explorer penetrates a crevice defect.
Measured: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Change in Surface Texture
Surface texture:
1. Surface texture is similar to polished enamel as determined by means of a sharp explorer.
2. Surface texture is gritty similar to a surface subject to a white stone or similar to a composite containing supramicron sizes particles.
3. Surface pitting is sufficiently coarse to inhibit the continuous movement of an explorer across the surface.
Measured: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Change in Restoration Wear
Wear
1. The restoration is continuation of existing anatomic form or is slightly flattened.
2. A surface concavity is evident.
3. There is a loss of restorative substance such that a surface concavity is evident. Replacement or restorative treatment is required.
Measured: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Recurrent dental caries
Recurrent dental caries:
1. The restoration is a continuation of existing anatomic form adjacent to the restoration.
2. There is visual evidence of dark deep discoloration adjacent to the restoration.
Measured: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
The Fracture/detachment Status
Fracture/detachment:
1. No bulk fracture/detachment is present.
2. Bulk fracture/ detachment is evident.
Measured: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Change in gingival status
Gingival status
1. No clinical inflammation is present.
2. Clinical inflammation is present.
Measured: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Oct 2015

First posted9 Jul 2014 (estimated)
Study startJul 2014
Primary completionJul 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Class II Dental RestorationsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02185573
Sponsor's protocol ID: UDDS-OperDent-01-2014
Status last verified: Oct 2015
First submitted: 4 Jul 2014
Last updated: 5 Oct 2015
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 24665478
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.
PubMed 24958689
Ching K. Deep and fast: Kerr's SonicFill bulk fill composite. HDA Now. 2012 Spring:24-5. No abstract available.
PubMed 22984718
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.
PubMed 24480086
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.
PubMed 24561041

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
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Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Active, not recruiting
Bioactive Restorative Materials for Class II Restorations
Bioactive Dental Restorative Materials, Class II Dental Caries
Recruiting
Clinical Performance of Bioactive Bulk-Fill in Class II Restorations
Dental Caries
Not yet recruiting
Bulk-Fill Composite Restorations: Clinical Evaluation
Composite Resins, Dental Caries Class II

All Class II Dental Restorations trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Two Different Methods of Resin Composite Application Using Bulk-fill Technique In Class II Restorations
ClinicalTrials.gov ID: NCT02185573
Acronym / sponsor ID: UDDS-OperDent-01-2014
Conditions: Class II Dental Restorations
Keywords: Bulk fill, SonicFill, resin composite application, class II restoration
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: Jul 2014
Primary completion: Jul 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 9 Jul 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Conventional Technique	No intervention	–Multi-layer filling technique
Bulk fill technique	Active comparator	Procedure: Bulk fillBulk fill technique
SonicFill technique	Experimental	Procedure: SonicFillSonicFill technique

Who may qualify

Ages: 15 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

Cooperated patients.
Good general health.
Good oral hygiene.
Aged 15 to 60 years.
Class II restoration (upper or lower)

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bulk fillThis is one of the composite restoration application techniques	Procedure or surgery	Bulk fill technique
SonicFillThis is the recent intervention under evaluation	Procedure or surgery	SonicFill technique

Primary outcome

Change in Color Match
Time frame: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Color match 1. The restoration appears to match the shade and translucency of adjacent tooth tissues. 2. The restoration does not match the shade and translucency of adjacent tooth tissues, but the mismatch is within the range of tooth shade. 3. The restoration does not match the shade and translucency of adjacent tooth tissues, and the mismatch is outside the normal range of tooth shade and translucency.
Change in Marginal Integrity
Time frame: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Marginal integrity 1. The explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does catch, there is no visible crevice along the periphery of the restoration. 2. The explorer catches and there is visible evidence of crevice, into which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. 3. the explorer penetrates a crevice defect.
Change in Surface Texture
Time frame: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Surface texture: 1. Surface texture is similar to polished enamel as determined by means of a sharp explorer. 2. Surface texture is gritty similar to a surface subject to a white stone or similar to a composite containing supramicron sizes particles. 3. Surface pitting is sufficiently coarse to inhibit the continuous movement of an explorer across the surface.
Change in Restoration Wear
Time frame: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Wear 1. The restoration is continuation of existing anatomic form or is slightly flattened. 2. A surface concavity is evident. 3. There is a loss of restorative substance such that a surface concavity is evident. Replacement or restorative treatment is required.
Recurrent dental caries
Time frame: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Recurrent dental caries: 1. The restoration is a continuation of existing anatomic form adjacent to the restoration. 2. There is visual evidence of dark deep discoloration adjacent to the restoration.
The Fracture/detachment Status
Time frame: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Fracture/detachment: 1. No bulk fracture/detachment is present. 2. Bulk fracture/ detachment is evident.
Change in gingival status
Time frame: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Gingival status 1. No clinical inflammation is present. 2. Clinical inflammation is present.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
Background: PubMed 24665478Manhart 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.
Background: PubMed 24958689van 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.
Background: PubMed 22984718Ching K. Deep and fast: Kerr's SonicFill bulk fill composite. HDA Now. 2012 Spring:24-5. No abstract available.
Background: PubMed 24480086Furness 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.
Background: PubMed 24561041Campos 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.

Related trials for Class II Dental Restorations

Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Active, not recruiting
Bioactive Restorative Materials for Class II Restorations
Bioactive Dental Restorative Materials, Class II Dental Caries
Recruiting
Clinical Performance of Bioactive Bulk-Fill in Class II Restorations
Dental Caries
Not yet recruiting
Bulk-Fill Composite Restorations: Clinical Evaluation
Composite Resins, Dental Caries Class II

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rahaf Alkurdi, DDS MSc principal investigator

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

Souad Abboud, DDS MSc PhD study director

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bulk fill and SonicFill in people with Class II Dental Restorations, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Color Match (time frame: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02185573, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.