SonicFill Clinical PerformanceNCT04926883
Comparison Between Sonic Fill and X-tra Fill in Clinical Performance
A study testing bulk-fill composite resin restorations in people with SonicFill Clinical Performance and Sonicated Bulk-fill Resin Composite, run by Minia University at 1 site in Egypt.
Trial summary
The present study aims to evaluate a 2-years clinical performance of sonic-activated bulk-fill resin composite material (sonic fill) in comparison to conventional bulk-fill resin composite (X-tra fill) as posterior restorations. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- SonicFill Clinical Performance, Sonicated Bulk-fill Resin Composite
- What is being tested?
- bulk-fill composite resin restorations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 30 Jun 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- They should have an acceptable oral hygiene level.
- Presence of at least two posterior carious lesions to be restored with two different types of composite.
- The two materials should be used in approximately the same sized lesions or within the same extension.
- Age range between 18 and 45 years.
- A good likelihood of recall availability.
Who cannot join
- Severe or active periodontal or carious disease.
- Heavy bruxism or a traumatic occlusion.
- Patients with a compromised medical history or had received therapeutic irradiation to the head and neck region.
- Alcoholic and smoker patients.
- Patients had participated in a clinical trial within 6 months before commencement of this trial.
- Patients unable to return for recall appointment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Sonic-Activated High Viscosity Bulk-Fill Resin Composite in Comparison to Conventional Bulk-Fill Resin Composite Restorations in Posterior Teeth: A Randomized Controlled Clinical Study.
The present study aims to evaluate a 2-years clinical performance of sonic-activated bulk-fill resin composite material (sonic fill) in comparison to conventional bulk-fill resin composite (X-tra fill) as posterior restorations. The null hypothesis is that sonic-activated bulk-fill resin composite restoration shows no difference when compared to conventional bulk-fill resin composite in clinical performance over 2-years evaluations based on clinical assessment.
Read the detailed description
Restorations will be evaluated 1 week after placement (Baseline - T0), 3 months (T1), 6 months (T2), 1-year (T3) and 2-years (T4) of clinical service by blinded calibrated examiner using modified United States Public Health Service (USPHS) criteria where score A (Alpha) stands for the clinically ideal restoration. Score B (Bravo) is a clinically acceptable situation except for secondary caries. Score C (Charlie) indicates clinically unacceptable restorations that must be replaced.
The restorations will also be evaluated using revised FDI criteria with five grades for each criterion; scores 1 to 3 indicated clinically acceptable restorations, and scores 4 and 5 summarized clinically unacceptable situations indicating repair (score 4) or replacement (score 5).
- Being tested
- bulk-fill composite resin restorations
- Keywords
- bulk-fill, resin composite, sonicfill, clinical performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bulk-fill composite resin restorationsOther
bulk-fill composite resin restorations up to 5mm layer thickness
| Study group | Role | What they receive |
|---|---|---|
| Sonic fill | Active comparator | Not described Receives: Other: bulk-fill composite resin restorations |
| X-tra fill | Active comparator | Not described Receives: Other: bulk-fill composite resin restorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in clinical performance
restorations' evaluation for retention, color matching, marginal discoloration, marginal adaptation, secondary caries, surface texture, anatomic form.
Score A (Alpha) stands for the clinically ideal restoration. Score B (Bravo) is a clinically acceptable situation except for secondary caries. Score C (Charlie) indicates clinically unacceptable restorations that must be replaced. Also will be scored from 1 to 5 , which 1 to 3 indicated clinically acceptable restorations, and scores 4 and 5 summarized clinically unacceptable situations indicating repair (score 4) or replacement (score 5).
Measured: 1 week, 3 months, 6 months, 12 months
Secondary outcomes (1)
change in post-operative pain using modified Visual Analogue Scale (VAS)
The patients will be asked to record their pain level on modified Visual Analogue Scale (VAS) from 0 to 10, where 10 means sever pain, for 1 week.
Measured: daily for 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
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 SonicFill Clinical PerformanceStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Aref, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926883
- Sponsor's protocol ID
- Bulkfill2021
- Status last verified
- Jul 2024
- First submitted
- 3 Jun 2021
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aref A, Abd-Elhakim S, Riad M. 24-month randomized controlled clinical trial assessment of surface texture, color stability, and marginal discoloration of sonic activated bulk-fill resin composite according to USPHS and FDI criteria. BMC Oral Health. 2025 Jul 26;25(1):1261. doi: 10.1186/s12903-025-06611-0.
PubMed 40713556
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Sonic-Activated High Viscosity Bulk-Fill Resin Composite in Comparison to Conventional Bulk-Fill Resin Composite Restorations in Posterior Teeth: A Randomized Controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT04926883
- Acronym / sponsor ID
- Bulkfill2021
- Keywords
- bulk-fill, resin composite, sonicfill, clinical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 15 Jun 2021 (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 present study aims to evaluate a 2-years clinical performance of sonic-activated bulk-fill resin composite material (sonic fill) in comparison to conventional bulk-fill resin composite (X-tra fill) as posterior restorations. The null hypothesis is that sonic-activated bulk-fill resin composite restoration shows no difference when compared to conventional bulk-fill resin composite in clinical performance over 2-years evaluations based on clinical assessment.
Detailed description
Restorations will be evaluated 1 week after placement (Baseline - T0), 3 months (T1), 6 months (T2), 1-year (T3) and 2-years (T4) of clinical service by blinded calibrated examiner using modified United States Public Health Service (USPHS) criteria where score A (Alpha) stands for the clinically ideal restoration. Score B (Bravo) is a clinically acceptable situation except for secondary caries. Score C (Charlie) indicates clinically unacceptable restorations that must be replaced.
The restorations will also be evaluated using revised FDI criteria with five grades for each criterion; scores 1 to 3 indicated clinically acceptable restorations, and scores 4 and 5 summarized clinically unacceptable situations indicating repair (score 4) or replacement (score 5).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonic fill | Active comparator | Other: bulk-fill composite resin restorations |
| X-tra fill | Active comparator | Other: bulk-fill composite resin restorations |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- They should have an acceptable oral hygiene level.
Key exclusion criteria (6 listed)
- Severe or active periodontal or carious disease.
- Heavy bruxism or a traumatic occlusion.
- Patients with a compromised medical history or had received therapeutic irradiation to the head and neck region.
- Alcoholic and smoker patients.
- Patients had participated in a clinical trial within 6 months before commencement of this trial.
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-fill composite resin restorationsbulk-fill composite resin restorations up to 5mm layer thickness | Other | Sonic fill, X-tra fill |
Primary outcome
change in clinical performance
Time frame: 1 week, 3 months, 6 months, 12 months
restorations' evaluation for retention, color matching, marginal discoloration, marginal adaptation, secondary caries, surface texture, anatomic form. Score A (Alpha) stands for the clinically ideal restoration. Score B (Bravo) is a clinically acceptable situation except for secondary caries. Score C (Charlie) indicates clinically unacceptable restorations that must be replaced. Also will be scored from 1 to 5 , which 1 to 3 indicated clinically acceptable restorations, and scores 4 and 5 summarized clinically unacceptable situations indicating repair (score 4) or replacement (score 5).
1 secondary outcome
change in post-operative pain using modified Visual Analogue Scale (VAS)
Time frame: daily for 1 week
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 23 Jul 2024.
- Derived from this study: PubMed 40713556Aref A, Abd-Elhakim S, Riad M. 24-month randomized controlled clinical trial assessment of surface texture, color stability, and marginal discoloration of sonic activated bulk-fill resin composite according to USPHS and FDI criteria. BMC Oral Health. 2025 Jul 26;25(1):1261. doi: 10.1186/s12903-025-06611-0.
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?
A study testing bulk-fill composite resin restorations in people with SonicFill Clinical Performance and Sonicated Bulk-fill Resin Composite, run by Minia University at 1 site in Egypt.
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 5 inclusion and 6 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 23 Jul 2024. 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?
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 clinical performance (time frame: 1 week, 3 months, 6 months, 12 months). 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 NCT04926883, 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 23 Jul 2024.