Dental CariesNCT05418400
Clinical Evaluation of Different Resin Composite Restorations
A study testing sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X in people with Dental Caries, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Posterior resin composite is challenging esthetic restoration. Patients seek for durable, esthetic and functional restorations in molars. one of the major problems is polymerization shrinkage. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2022to 1 Nov 2023
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male gender
- Good oral hygiene
- Only Cooperative patient
- Medically free patient
- Age range 18-24
- Vital teeth with no periapical lesion or radiolucency.
Show all 9Show fewer
- Prepared cavity with no undermined enamel walls.
- Functioning tooth with presence of an opposing.
- Healthy periodontium.
Who cannot join
- Old age patients
- Patients have systemic disease or sever medically compromised
- Patients with bruxism, clenching or temporomandibular joint disorder.
- Por oral hygiene
- Teeth with periapical lesions.
- Teeth with visible cracks.
Show all 10Show fewer
- Teeth with mobility.
- Non-functioning tooth with no opposing tooth.
- Heavy occlusion or signs of sever attrition.
- Tooth with Periodontal affection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Clinical Criteria of Different Resin Composite Restorations Among Lower Molars
Posterior resin composite is challenging esthetic restoration. Patients seek for durable, esthetic and functional restorations in molars. one of the major problems is polymerization shrinkage. Some materials were developed to overcome the polymerization shrinkage, among them bulk fill resin composite which have been developed to reduce the shrinkage stress during polymerization and offer much greater depth of cure. This is achieved by the addition of fillers such as barium aluminum silicate filler, ytterbium trifluoride and mixed oxides. Furthermore, a prepolymerized fillers have been added with silanes to reduce shrinkage stress. so, the objective of this trial is to clinical Evaluate and compare clinical performance of bulk fill VS incremental filling technique.
- Conditions
- Dental Caries
- Being tested
- sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X
- Keywords
- composite resin
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-XOther
dental filling materials
| Study group | Role | What they receive |
|---|---|---|
| bulkfill composites | Active comparator | sonic fill 3 \& PALFIQUE bulk flow bulk fill composite Receives: Other: sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X |
| incremental composites | Active comparator | Neo spectra \& Clear fill AP-X incremental composites Receives: Other: sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative sensitivity
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)
Measured: along one year
marginal discoloration
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)
Measured: along one year
marginal adaptation
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)
Measured: along one year
recurrent caries
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)
Measured: along one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start15 Aug 2022
- Primary completion2 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Basha, Al-Azhar University
- Investigators
- Nady Ebrahem Hasanin, professor, Study chair, Faculty of dental medicine Al Azhar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418400
- Sponsor's protocol ID
- 732/385
- Status last verified
- Sep 2022
- First submitted
- 5 Jun 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Clinical Criteria of Different Resin Composite Restorations Among Lower Molars
- ClinicalTrials.gov ID
- NCT05418400
- Acronym / sponsor ID
- 732/385
- Conditions
- Dental Caries
- Keywords
- composite resin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 2 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 14 Jun 2022 (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.
Posterior resin composite is challenging esthetic restoration. Patients seek for durable, esthetic and functional restorations in molars. one of the major problems is polymerization shrinkage. Some materials were developed to overcome the polymerization shrinkage, among them bulk fill resin composite which have been developed to reduce the shrinkage stress during polymerization and offer much greater depth of cure. This is achieved by the addition of fillers such as barium aluminum silicate filler, ytterbium trifluoride and mixed oxides. Furthermore, a prepolymerized fillers have been added with silanes to reduce shrinkage stress. so, the objective of this trial is to clinical Evaluate and compare clinical performance of bulk fill VS incremental filling technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bulkfill composites | Active comparator | Other: sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-Xsonic fill 3 \& PALFIQUE bulk flow bulk fill composite |
| incremental composites | Active comparator | Other: sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-XNeo spectra \& Clear fill AP-X incremental composites |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male gender
- Good oral hygiene
- Only Cooperative patient
- Medically free patient
- Age range 18-24
Key exclusion criteria (10 listed)
- Teeth with periapical lesions.
- Teeth with visible cracks.
- Teeth with mobility.
- Non-functioning tooth with no opposing tooth.
- Heavy occlusion or signs of sever attrition.
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 |
|---|---|---|
| sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-Xdental filling materials | Other | bulkfill composites, incremental composites |
Primary outcome
Post operative sensitivity
Time frame: along one year
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)
marginal discoloration
Time frame: along one year
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)
marginal adaptation
Time frame: along one year
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)
recurrent caries
Time frame: along one year
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Nady Ebrahem Hasanin, professor study chair
Faculty of dental medicine Al Azhar university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X in people with Dental Caries, run by Al-Azhar 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 9 inclusion and 10 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 28 Sep 2022. 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?
Post operative sensitivity (time frame: along one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2022.