Dental Caries Class vNCT04053530
Evaluation of the Marginal Integrity of Recent Bulk Fill Flowable Composite vs Glass Ionomer for Carious Cervical Restorations: RCCT
A study testing restorative materials in people with Dental Caries Class v, run by Cairo University at 2 sites in Egypt.
Trial summary
The study will be conducted to assess the marginal integrity of different types of restorations (ketac ™ N100 - ketac™ Universal and bulk fill flowable composite) in class v restoration using USPHS criteria. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries Class v
- What is being tested?
- restorative materials
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesEgypt
- Study dates
- 4 Aug 2019to 15 Oct 2020
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of at least one carious buccal cervical lesion.
- The absence of tooth mobility.
- Presence of contact with opposite teeth without any abnormal occlusion stress for the selected teeth.
- Accessible isolation and observable and easily accessible gingival margins during tooth restoration.
Who cannot join
- Patients with poor oral hygiene.
- The presence of any para functional habit.
- Abnormal occlusion.
- Any regurgitation problem.
- Subjects with compromised medical history.
- Pulpitis, non-vital or endodontically treated teeth.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluation of the Marginal Integrity of Recent Bulk Fill Flowable Composite vs Glass Ionomer for Carious Cervical Restorations: Randomized Controlled Clinical Trail
The study will be conducted to assess the marginal integrity of different types of restorations (ketac ™ N100 - ketac™ Universal and bulk fill flowable composite) in class v restoration using USPHS criteria.
- Conditions
- Dental Caries Class v
- Being tested
- restorative materials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restorative materialsOther
glass ionomer and bulk fill flowable composite
| Study group | Role | What they receive |
|---|---|---|
| 3M™ Ketac™ Universal Aplicap™ | Experimental | 3M™ Ketac™ Universal Aplicap™ Glass Ionomer Restorative Clean the cavity preparation with water. Rinse thoroughly and dry. Extrude the mixed ketac universal out of the capsule directly into the prepared cavity with a capsule gun. Please ensure that no air bubbles are included.
It is recommended that the finishing and polishing can be continued after approximately 4 minutes after the start of the mixing or earlier if heat is applied for faster setting. The finishing and polishing can be done immediately after final setting with Extra-Fine, Friction Grip diamonds under water-cooling. Receives: Other: restorative materials |
| Filtek™ Bulk Fill Flowable composite | Experimental | Filtek™ Bulk Fill Flowable Restorative is the 3M ESPE choice in the bulk fill flowable category.
Selective etching 15-20 s for enamel. The adhesive system (BISCO universal all bond) will be applied following the manufacturer's instructions (apply 2 coats 20 s before curing). Bulk fill flowable composite will be light cured for 40 s using a visible light curing unit. Receives: Other: restorative materials |
| ketac N100 | Active comparator | Ketac™ Nano Light Curing Glass Ionomer Restorative. Primer will be applied to both enamel and dentinal surfaces for 15 seconds. The prepared tooth surfaces will be wet with the primer for the full application time.
Dispensing two clicks from the Clicker™ Dispenser will provide an adequate amount of material for most restorative filling applications.
It will be placed with a syringe system then will be placed in 2mm increments or less, and light cured after each increment. An LED curing light will cure all shades with a 20 second light exposure.
Finishing Ketac Nano restorative will be polished with conventional finishing and polishing instruments such as a diamond impregnated rubberized polishing system under water spray. A glaze such as Vitremer™ Finishing Gloss will be applied after polishing if desired. Receives: Other: restorative materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
is marginal integrity of restoration.
Primary outcome is marginal integrity of restoration. It will be assessed by USPHS; score will be recorded according to USPHS criteria (Nassar et al., 2014).
- MARGINAL INTEGRITY
Alpha (A) Visual inspection and explorer The explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does not catch, there is no visible crevice along the periphery of the restoration.
Bravo (B) Visual inspection and explorer The explorer catches and there is visible evidence of a crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. The dentin and/or the base is not exposed, and the restoration is not mobile.
Charlie (C) Explorer The explorer penetrates crevice defect extended to the dentino-enamel junction.
Delta (D) Mobile, fractured or missing restoration in a part or total
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start4 Aug 2019
- Primary completion3 Aug 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries Class vStudies 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
- 3 parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Reda Abd EL Rahman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053530
- Sponsor's protocol ID
- oper 5215
- Status last verified
- Jan 2021
- First submitted
- 8 Aug 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Marginal Integrity of Recent Bulk Fill Flowable Composite vs Glass Ionomer for Carious Cervical Restorations: Randomized Controlled Clinical Trail
- ClinicalTrials.gov ID
- NCT04053530
- Acronym / sponsor ID
- oper 5215
- Conditions
- Dental Caries Class v
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Aug 2019 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 12 Aug 2019 (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 study will be conducted to assess the marginal integrity of different types of restorations (ketac ™ N100 - ketac™ Universal and bulk fill flowable composite) in class v restoration using USPHS criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3 parallel groups
| Arm | Type | Receives |
|---|---|---|
| 3M™ Ketac™ Universal Aplicap™ | Experimental | Other: restorative materials3M™ Ketac™ Universal Aplicap™ Glass Ionomer Restorative Clean the cavity preparation with water. Rinse thoroughly and dry. Extrude the mixed ketac universal out of the capsule directly into the prepared cavity with a capsule gun. Please ensure that no air bubbles are included. It is recommended that the finishing and polishing can be continued after approximately 4 minutes after the start of the mixing or earlier if heat is applied for faster setting. The finishing and polishing can be done immediately after final setting with Extra-Fine, Friction Grip diamonds under water-cooling. |
| Filtek™ Bulk Fill Flowable composite | Experimental | Other: restorative materialsFiltek™ Bulk Fill Flowable Restorative is the 3M ESPE choice in the bulk fill flowable category. Selective etching 15-20 s for enamel. The adhesive system (BISCO universal all bond) will be applied following the manufacturer's instructions (apply 2 coats 20 s before curing). Bulk fill flowable composite will be light cured for 40 s using a visible light curing unit. |
| ketac N100 | Active comparator | Other: restorative materialsKetac™ Nano Light Curing Glass Ionomer Restorative. Primer will be applied to both enamel and dentinal surfaces for 15 seconds. The prepared tooth surfaces will be wet with the primer for the full application time. Dispensing two clicks from the Clicker™ Dispenser will provide an adequate amount of material for most restorative filling applications. It will be placed with a syringe system then will be placed in 2mm increments or less, and light cured after each increment. An LED curing light will cure all shades with a 20 second light exposure. Finishing Ketac Nano restorative will be polished with conventional finishing and polishing instruments such as a diamond impregnated rubberized polishing system under water spray. A glaze such as Vitremer™ Finishing Gloss will be applied after polishing if desired. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Presence of at least one carious buccal cervical lesion.
- The absence of tooth mobility.
- Presence of contact with opposite teeth without any abnormal occlusion stress for the selected teeth.
- Accessible isolation and observable and easily accessible gingival margins during tooth restoration.
Key exclusion criteria (6 listed)
- Patients with poor oral hygiene.
- The presence of any para functional habit.
- Abnormal occlusion.
- Any regurgitation problem.
- Subjects with compromised medical history.
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 |
|---|---|---|
| restorative materialsglass ionomer and bulk fill flowable composite | Other | 3M™ Ketac™ Universal Aplicap™, Filtek™ Bulk Fill Flowable composite, ketac N100 |
Primary outcome
is marginal integrity of restoration.
Time frame: 12 months
Primary outcome is marginal integrity of restoration. It will be assessed by USPHS; score will be recorded according to USPHS criteria (Nassar et al., 2014). 1. MARGINAL INTEGRITY Alpha (A) Visual inspection and explorer The explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does not catch, there is no visible crevice along the periphery of the restoration. Bravo (B) Visual inspection and explorer The explorer catches and there is visible evidence of a crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. The dentin and/or the base is not exposed, and the restoration is not mobile. Charlie (C) Explorer The explorer penetrates crevice defect extended to the dentino-enamel junction. Delta (D) Mobile, fractured or missing restoration in a part or total
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 27 Jan 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing restorative materials in people with Dental Caries Class v, run by Cairo University at 2 sites 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 4 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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
is marginal integrity of restoration. (time frame: 12 months). 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 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.