CompletedNot Applicable

Assessment of Alkasite Restorative Material Versus Resin Modified Glass Ionomer in Class V Cavities: A Clinical Trial

Egypt50 participantsStarted 2024-12-01

Plain-language summary

This study will be conducted to evaluate the clinical assessment of an alkasite based resin composite restorative material compared to resin modified glass ionomer based restorative material in class V cavities of anterior teeth over 12 months follow up using modified USPHS criteria. In patients with anterior cervical (class V) carious lesions, will the novel alkasite-based restorative material show similar clinical assessment as resin modified glass ionomer over a one year follow up period?

Who can participate

Age range

30 Years – 40 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: * • Adults (30-40Ys) with class V cavities (ICDAS 4 or 5) in upper anterior teeth. * Males or females. * Have sufficient cognitive ability to understand consent procedures. * Co-operative patients approving to participate in the trial. * Anterior tooth cervical carious lesion with ICDAS score 4 or 5. * Vital upper anterior teeth with no signs or symptoms of irreversible pulpitis. * Mobility grade: no clinical mobility. * Teeth with healthy periodontium. Exclusion Criteria: * • Disabilities. * Systemic diseases or severe medically compromised. * Lack of compliance. * Evidence of severe bruxism, clenching or temporomandibular joint disorders. * Cognitive impairment * Periapical pathosis or signs of pulpal pathology. * Non-vital tooth. * Signs of pathological wear. * Endodontically treated tooth. * Severe periodontal affection or tooth indicated for extraction.

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

clinical assessment

Timeframe: 12 months change from base line to six and 12 months.

Trial details

NCT IDNCT06673888

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-01

View on ClinicalTrials.gov More Class V Dental Caries trials