Bulk-fill Which is Special Type of Resin CompositeNCT05861908

Bulk-fill With Different Technique Three-year Clinical Performance

A study testing Filtek™ Bulk Fill restoration, Heated Filtek™ Bulk Fill restoration and G-aenial™ BULK Injectable restoration in people with Bulk-fill Which is Special Type of Resin Composite and Bisphenol A-Glycidyl Methacrylate, run by Mansoura University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Bulk-fill Which is Special Type of Resin Composite, Bisphenol A-Glycidyl Methacrylate
What is being tested?: Filtek™ Bulk Fill restoration, Heated Filtek™ Bulk Fill restoration and G-aenial™ BULK Injectable restoration
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteEgypt
Study dates: 9 May 2021to 9 May 2024
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 18 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Show all 9Show fewer

Maxillary or mandibular first or second molars
Tooth with antagonist and adjacent mesial and distal tooth contact,
Normal response to a vitality test.

Who cannot join

Poor oral hygiene
Severe or chronic periodontitis
Heavy bruxism
Occlusion fewer than 20 teeth
Sensitivity to resin-based material.
Patients with orthodontic treatment

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Operative Department, Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 0000

Other trials in Egypt

About this study

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

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.

Read the 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

Conditions: Bulk-fill Which is Special Type of Resin Composite, Bisphenol A-Glycidyl Methacrylate
Being tested: Filtek™ Bulk Fill restoration, Heated Filtek™ Bulk Fill restoration, G-aenial™ BULK Injectable restoration, Sonicfill3 restoration

What participants receive

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

Filtek™ Bulk Fill restorationOther
restoration of class II caries with different bulk-fill technique
Heated Filtek™ Bulk Fill restorationOther
restoration of class II caries with different bulk-fill technique
G-aenial™ BULK Injectable restorationOther
restoration of class II caries with different bulk-fill technique
Sonicfill3 restorationOther
restoration of class II caries with different bulk-fill technique

Study groups in NCT05861908
Study group	Role	What they receive
Body Bulk-Fill	Experimental	20 cavity class II restored with Body bulk-fill Resin composite Receives: Other: Filtek™ Bulk Fill restoration
preheated Bulk-Fill	Experimental	20 cavity class II restored with preheated bulk-fill Resin composite Receives: Other: Heated Filtek™ Bulk Fill restoration
Injectable Bulk-Fill	Experimental	20 cavity class II restored with injectable bulk-fill Resin composite Receives: Other: G-aenial™ BULK Injectable restoration
Sonic-Fill	Experimental	20 cavity class II restored with sonic-fill bulk-fill Resin composite Receives: Other: Sonicfill3 restoration

What is being measured

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

Esthetic Properties of restorations
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
Measured: Three years Follow up
Functional Properties of restorations
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
Measured: Three years Follow up
Biological Properties of restorations
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
Measured: Three years Follow up

Timeline

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

9 May 20219 May 2024

First posted17 May 2023
Study start9 May 2021
Primary completion9 May 2022
Study completion9 May 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bulk-fill Which is Special Type of Resin CompositeStudies 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
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
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05861908
Sponsor's protocol ID: M01060421
Status last verified: Mar 2023
First submitted: 29 Mar 2023
Last updated: 17 May 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Goda B, Eltoukhy RI, Ali AI, Mahmoud SH. Wear performance of different bulk-fill class II resin composite restorations: 3-year clinical evaluation. Sci Rep. 2026 Mar 27;16(1):10362. doi: 10.1038/s41598-026-41420-7.
PubMed 41888286

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Placement Techniques on Three-year Clinical Performance of Class II Bulk-fill Resin Composite Restorations and Laboratory Investigation of Marginal Adaptation
ClinicalTrials.gov ID: NCT05861908
Acronym / sponsor ID: M01060421
Conditions: Bulk-fill Which is Special Type of Resin Composite, Bisphenol A-Glycidyl Methacrylate
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 50 participants (actual)
Lead sponsor: Mansoura UniversityUniversity, hospital or other
Study start: 9 May 2021 (actual)
Primary completion: 9 May 2022 (actual)
Study completion: 9 May 2024 (estimated)
First posted: 17 May 2023 (actual)
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.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4
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

Arm	Type	Receives
Body Bulk-Fill	Experimental	Other: Filtek™ Bulk Fill restoration20 cavity class II restored with Body bulk-fill Resin composite
preheated Bulk-Fill	Experimental	Other: Heated Filtek™ Bulk Fill restoration20 cavity class II restored with preheated bulk-fill Resin composite
Injectable Bulk-Fill	Experimental	Other: G-aenial™ BULK Injectable restoration20 cavity class II restored with injectable bulk-fill Resin composite
Sonic-Fill	Experimental	Other: Sonicfill3 restoration20 cavity class II restored with sonic-fill bulk-fill Resin composite

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (11 listed)

Poor oral hygiene
Severe or chronic periodontitis
Heavy bruxism
Occlusion fewer than 20 teeth
Sensitivity to resin-based material.

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
Filtek™ Bulk Fill restorationrestoration of class II caries with different bulk-fill technique	Other	Body Bulk-Fill
Heated Filtek™ Bulk Fill restorationrestoration of class II caries with different bulk-fill technique	Other	preheated Bulk-Fill
G-aenial™ BULK Injectable restorationrestoration of class II caries with different bulk-fill technique	Other	Injectable Bulk-Fill
Sonicfill3 restorationrestoration of class II caries with different bulk-fill technique	Other	Sonic-Fill

Primary outcome

Esthetic Properties of restorations
Time frame: 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
Time frame: 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
Time frame: 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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
Derived from this study: PubMed 41888286Goda B, Eltoukhy RI, Ali AI, Mahmoud SH. Wear performance of different bulk-fill class II resin composite restorations: 3-year clinical evaluation. Sci Rep. 2026 Mar 27;16(1):10362. doi: 10.1038/s41598-026-41420-7.
Individual participant dataSharing planned: Undecided

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 17 May 2023. 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 Egypt. 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?

Results are not available in the source record.

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?

Esthetic Properties of restorations (time frame: Three years Follow up). The study lists 3 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 NCT05861908, which also lists 1 linked publication.

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 17 May 2023.