Dental Caries in ChildrenNCT05173753
Novel Self-Adhesive Composite Hybrid Versus Conventional Composite in Restoration of Carious Primary Teeth.
A study testing Novel self-adhesive hybrid composite(Surefil one) in people with Dental Caries in Children, run by Cairo University.
Trial summary
The clinical trial aim to evaluate clinical effectiveness of self-adhesive composite hybrid (Surefil one) versus conventional composite(VOCO Grandio) as restorative material for carious primary teeth. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Novel self-adhesive hybrid composite(Surefil one)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Jun 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children:
- Good general health and medically free patients. Age ranges: from 4-7 years old. A provided informed consent by the parents. Acceptable child cooperation.
- Teeth:
- Class I carious primary teeth. 2 contralateral or adjacent carious teeth. Simple caries, extending to the dentin. No singe or symptom of pulp inflammation. Normal radiographic examination.
Who cannot join
- Children:
- Unable to attend follow-up visits. Refusal of participation.
- Teeth:
- Symptom tooth. Periapical Pathosis. Mobile primary tooth.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Novel Self-Adhesive Composite Hybrid Versus Conventional Composite in Restoration of Carious Primary Teeth. A Split Mouth Randomized Clinical Trial
The clinical trial aim to evaluate clinical effectiveness of self-adhesive composite hybrid (Surefil one) versus conventional composite(VOCO Grandio) as restorative material for carious primary teeth.
Read the detailed description
Composite resin is a continuous improving material as its full fill many requirements seeking in dental restorative materials, but is the new introducing composite resin material is always better than the previous one? This randomized clinical trial is performed to discus and assess that hypothesis. A total of 120 class I restoration(60 Surefil one novel self-adhesive composite hybrid \& 60 VOCO Grandio conventional composite resin) will be placed in posterior teeth of 60 volunteers(splint mouth design) following the manufacturer instruction. age between 4-7 years. The restorations will then be evaluate clinically at baseline, 3, and 6 month intervene. Both the procedure and follow up will done in the out-patient clinic, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.
- Conditions
- Dental Caries in Children
- Being tested
- Novel self-adhesive hybrid composite(Surefil one)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel self-adhesive hybrid composite(Surefil one)Other
Surefil one, is a recent introduced esthetic dental restoration for treatment of carious teeth.
| Study group | Role | What they receive |
|---|---|---|
| Novel self-adhesive composite restoration (Surefil one) | Active comparator | Not described Receives: Other: Novel self-adhesive hybrid composite(Surefil one) |
| conventional composite resin restoration(VOCO Grandio) | Active comparator | Not described Receives: Other: Novel self-adhesive hybrid composite(Surefil one) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical effectiveness
The two materials will be evaluated using the FDI World Federation criteria.
Measured: 6 month intervene
Secondary outcomes (3)
The cost effectiveness
will be measured using the ICER (Incremental cost-effectiveness ratio)
Measured: 6 month intervene
Duration of procedure
measure using stop watch
Measured: 6 month intervene
Child cooperation
Wright Modification of Frankl behavior scale will be use(Rating1-5 as R1 definitely negative, and R5 definitely positive).
Measured: 6 month intervene
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study startAug 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- for both the intervention group and control group, the procedure and follow up will be done parallel to each other(same time).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Elfadil Rabie, Cairo University
- Investigators
- Kamal Aldin El Motayam, Professor, Study director, Cairo UniversityPassant Nagi, PHD, Study director, Cairo UniversityMahitab M Abdel khalek, BDS, Principal investigator, Cairo UniversityFatema H Mohamed, BDS, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173753
- Sponsor's protocol ID
- Surefil one in primary teeth
- Status last verified
- Jul 2022
- First submitted
- 4 Dec 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Self-Adhesive Composite Hybrid Versus Conventional Composite in Restoration of Carious Primary Teeth. A Split Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05173753
- Acronym / sponsor ID
- Surefil one in primary teeth
- Conditions
- Dental Caries in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 30 Dec 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 clinical trial aim to evaluate clinical effectiveness of self-adhesive composite hybrid (Surefil one) versus conventional composite(VOCO Grandio) as restorative material for carious primary teeth.
Detailed description
Composite resin is a continuous improving material as its full fill many requirements seeking in dental restorative materials, but is the new introducing composite resin material is always better than the previous one? This randomized clinical trial is performed to discus and assess that hypothesis. A total of 120 class I restoration(60 Surefil one novel self-adhesive composite hybrid \& 60 VOCO Grandio conventional composite resin) will be placed in posterior teeth of 60 volunteers(splint mouth design) following the manufacturer instruction. age between 4-7 years. The restorations will then be evaluate clinically at baseline, 3, and 6 month intervene. Both the procedure and follow up will done in the out-patient clinic, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- for both the intervention group and control group, the procedure and follow up will be done parallel to each other(same time).
| Arm | Type | Receives |
|---|---|---|
| Novel self-adhesive composite restoration (Surefil one) | Active comparator | Other: Novel self-adhesive hybrid composite(Surefil one) |
| conventional composite resin restoration(VOCO Grandio) | Active comparator | Other: Novel self-adhesive hybrid composite(Surefil one) |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Good general health and medically free patients. Age ranges: from 4-7 years old. A provided informed consent by the parents. Acceptable child cooperation.
- Class I carious primary teeth. 2 contralateral or adjacent carious teeth. Simple caries, extending to the dentin. No singe or symptom of pulp inflammation. Normal radiographic examination.
Key exclusion criteria (4 listed)
- Unable to attend follow-up visits. Refusal of participation.
- Symptom tooth. Periapical Pathosis. Mobile primary tooth.
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 |
|---|---|---|
| Novel self-adhesive hybrid composite(Surefil one)Surefil one, is a recent introduced esthetic dental restoration for treatment of carious teeth. | Other | Novel self-adhesive composite restoration (Surefil one), conventional composite resin restoration(VOCO Grandio) |
Primary outcome
clinical effectiveness
Time frame: 6 month intervene
The two materials will be evaluated using the FDI World Federation criteria.
3 secondary outcomes
The cost effectiveness
Time frame: 6 month intervene
Duration of procedure
Time frame: 6 month intervene
Child cooperation
Time frame: 6 month intervene
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
Kamal Aldin El Motayam, Professor study director
Cairo University
Passant Nagi, PHD study director
Cairo University
Mahitab M Abdel khalek, BDS principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Novel self-adhesive hybrid composite(Surefil one) in people with Dental Caries in Children, run by Cairo University.
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 4 inclusion and 4 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 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact fatima E Rabie, BDS (1019685330 ext. +20, fatima.rabie@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical effectiveness (time frame: 6 month intervene). 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 27 Jul 2022.