CompletedEarly Phase 1

Clinical Evaluation of Fiber Reinforced Resin Composite Base Versus Incremental Packing of Nanohybrid Resin Composite

Egypt36 participantsStarted 2020-09-01

Plain-language summary

A clinical trial, comparing two different incrementation techniques in the restoration of proximal caries in permanent posterior teeth . One utilizes a fiber reinforced bulk fill base material, followed by an occlusal nanohybrid capping layer. The other utilizes incremental packing of nanohybrid resin composite material to fill the whole cavity.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patient-related criteria: * Patients consulting in one of the outpatient clinic listed above. * Able to tolerate necessary restorative procedures. * Provide informed consent. * Accepts the one year follow-up period. Tooth related criteria: * Teeth with primary deep carious lesions involving 2/3 of the entire dentin thickness with no continuity between the carious cavity and the pulp chamber. * Teeth are vital according to pulp-sensitivity tests. Exclusion Criteria: Patient-related criteria: * Medically compromised patients, as they will not be able to attend multiple appointments or may require special management. * Pregnant women; as radiographs cannot be taken for them. * Allergy to any of the restorative materials, including anesthetics. * Uncooperative patients, will not abide by the instructions or attend the appointments. Tooth related criteria: * Deciduous teeth; as the study is targeting only permanent teeth. * Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries). * Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests), which would indicate irreversible pulpal damage. * Negative sensitivity tests, periapical radiolucencies and sensitivity to axial or lateral percussion, which would indicate pulp necrosis. * Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mechanical outcome according to USPHS criteria

Timeframe: 12 months

Trial details

NCT IDNCT04019145

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-01

View on ClinicalTrials.gov More Caries Class II trials