Dental Restoration FailureNCT03859284
Evaluation of Adhering Flowable Composite With and Without Adhesive Vs Flowable in Cervical Lesions
A study testing flowable resin composite, self adhering flowable and self adhering flowable with adhesive in people with Dental Restoration Failure, run by Cairo University at 1 site in Egypt.
Trial summary
With limited evidence-based information in literature about using self-adhering flowable composite in conservative class V restorations, it was found beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that moist bonding self-adhering flowable… Read more about this study
- Who is it for?
- Ages 16 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure
- What is being tested?
- flowable resin composite, self adhering flowable and self adhering flowable with adhesive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2020to 1 Jun 2022
- 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 16 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients with anterior cervical carious lesions.
- Pulp asymptomatic vital carious anterior teeth.
- Co-operative patients approving to participate in the trial.
Who cannot join
- Pregnancy.
- Disabilities.
- Systemic disease or severe medical complications.
- Deep extensive carious cavities that may lead to the fracture of the tooth or pulpal affection.
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
- Heavy smokers.
Trial locations and contacts
1 site in 1 country.
hussein gomaa, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry Cairo University
Giza
faculty of dentistry
About this study
Official title: Clinical Evaluation of a Moist Bonding Self-Adhering Flowable Composite With and Without Adhesive System Versus Conventional Flowable Composite in Cervical Caries Lesions: Randomized Clinical Trial
With limited evidence-based information in literature about using self-adhering flowable composite in conservative class V restorations, it was found beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that moist bonding self-adhering flowable composite with and without adhesive system will have the same clinical performance as conventional flowable composite in cervical caries lesions.
Read the detailed description
flowable composite is considered a gold standard in class V restorations due to its resilient character the prevents its dislodgement in this area. self-adhering flowable composite would simplify the clinical steps and claims to improve the adhesion.
- Conditions
- Dental Restoration Failure
- Being tested
- flowable resin composite, self adhering flowable, self adhering flowable with adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flowable resin compositeOther
Also called conventional flowable composite
gold standard
self adhering flowableOther
Also called embrace wet bond
moist bonding self adhering flowable composite
self adhering flowable with adhesiveOther
Also called embrace wet bond with adhesive
moist bonding self adhering flowable composite with the aid of an adhesive system.
| Study group | Role | What they receive |
|---|---|---|
| flowable resin-composite | Active comparator | 3M flowable composite is a conventional restoration to treat anterior carious cervical lesions. considered to be the gold standard of the flowable composites.
other names: ''flowable composite '' Receives: Other: flowable resin composite |
| self-adhering flowable | Experimental | intervention one is moist bonding self adhering flowable composite that binds to tooth without an adhesive system Receives: Other: self adhering flowable |
| self-adhering flowable with adhesive | Experimental | intervention two moist bonding self adhering flowable composite that binds to tooth with the aid of adhesive system to improve the clinical performance Receives: Other: self adhering flowable with adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of the direct restoration. (FDI) criteria includes
Biological properties (Postoperative hypersensitivity \& tooth vitality, Recurrence of caries, erosion \& abfraction,Tooth integrity (enamel cracks or tooth fractures),Periodontal response (compared to a reference tooth),Adjacent mucosa, Oral \& general health).
Esthetic properties (Surface luster, Staining (surface \&margin),Color match \& translucency \& Esthetic anatomical form).
Functional properties (Fracture or material retention, Marginal integrity, Occlusal contour \&wear (quantitatively \& qualitatively), Proximal anatomical form(contact point \&contour), Radiographic examination(when applicable) \&Patient's view
For each criteria one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor).
Subscales will not be combined
Measured: Change from the baseline at 6 months and12 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start20 Jun 2020
- Primary completionFeb 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Restoration FailureStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mounir Ibrahim Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859284
- Sponsor's protocol ID
- Mon15
- Status last verified
- Oct 2020
- First submitted
- 12 Feb 2019
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Moist Bonding Self-Adhering Flowable Composite With and Without Adhesive System Versus Conventional Flowable Composite in Cervical Caries Lesions: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03859284
- Acronym / sponsor ID
- Mon15
- Conditions
- Dental Restoration Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 1 Mar 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.
With limited evidence-based information in literature about using self-adhering flowable composite in conservative class V restorations, it was found beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that moist bonding self-adhering flowable composite with and without adhesive system will have the same clinical performance as conventional flowable composite in cervical caries lesions.
Detailed description
flowable composite is considered a gold standard in class V restorations due to its resilient character the prevents its dislodgement in this area. self-adhering flowable composite would simplify the clinical steps and claims to improve the adhesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| flowable resin-composite | Active comparator | Other: flowable resin composite3M flowable composite is a conventional restoration to treat anterior carious cervical lesions. considered to be the gold standard of the flowable composites. other names: ''flowable composite '' |
| self-adhering flowable | Experimental | Other: self adhering flowableintervention one is moist bonding self adhering flowable composite that binds to tooth without an adhesive system |
| self-adhering flowable with adhesive | Experimental | Other: self adhering flowable with adhesiveintervention two moist bonding self adhering flowable composite that binds to tooth with the aid of adhesive system to improve the clinical performance |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- patients with anterior cervical carious lesions.
- Pulp asymptomatic vital carious anterior teeth.
- Co-operative patients approving to participate in the trial.
Key exclusion criteria (6 listed)
- Pregnancy.
- Disabilities.
- Systemic disease or severe medical complications.
- Deep extensive carious cavities that may lead to the fracture of the tooth or pulpal affection.
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
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 |
|---|---|---|
| flowable resin compositeAlso: conventional flowable compositegold standard | Other | flowable resin-composite |
| self adhering flowableAlso: embrace wet bondmoist bonding self adhering flowable composite | Other | self-adhering flowable |
| self adhering flowable with adhesiveAlso: embrace wet bond with adhesivemoist bonding self adhering flowable composite with the aid of an adhesive system. | Other | self-adhering flowable with adhesive |
Primary outcome
Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of the direct restoration. (FDI) criteria includes
Time frame: Change from the baseline at 6 months and12 months]
Biological properties (Postoperative hypersensitivity \& tooth vitality, Recurrence of caries, erosion \& abfraction,Tooth integrity (enamel cracks or tooth fractures),Periodontal response (compared to a reference tooth),Adjacent mucosa, Oral \& general health). Esthetic properties (Surface luster, Staining (surface \&margin),Color match \& translucency \& Esthetic anatomical form). Functional properties (Fracture or material retention, Marginal integrity, Occlusal contour \&wear (quantitatively \& qualitatively), Proximal anatomical form(contact point \&contour), Radiographic examination(when applicable) \&Patient's view For each criteria one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor). Subscales will not be combined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
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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.
hussein gomaa, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flowable resin composite, self adhering flowable and self adhering flowable with adhesive in people with Dental Restoration Failure, run by Cairo 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 3 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: status not confirmed, as of the sponsor's last update on 29 Oct 2020. 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?
Contact mona mounir, msc (01001171585, monamounir1987@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of the direct restoration. (FDI) criteria includes (time frame: Change from the baseline at 6 months and12 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 29 Oct 2020.