Remineralization Efficacy of Moringa Oleifera Varnish Vs MI Varnish in Initial Carious Lesions Ov… (NCT06905379) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Remineralization Efficacy of Moringa Oleifera Varnish Vs MI Varnish in Initial Carious Lesions Over 6 Months Follow Up: a Randomized Controlled Clinical Trial
Egypt40 participantsStarted 2025-05-01
Plain-language summary
This randomized clinical trial aimed to test the remineralization effect of laboratory prepared Moringa Oleifera based varnish compared to MI varnish (CPP-ACP) on incipient carious lesions. The study could include any of the following participants: age: 25-35 years, males or females, presentation with at least one active WSLs on the study teeth at the start of the study, good oral hygiene, co-operative patients approving to participate in the trial, have sufficient cognitive ability to understand consent procedures. The main question it aims to answer is in patients with initial caries lesions will Moringa Oleifera varnish have same remineralization efficacy as MI Varnish after 6 months follow up? MI varnish will be used as a comparator as it has been shown in many studies to be superior to fluoride varnish with NaF alone in arresting early caries lesions. The active ingredient, CPP-ACP can slowly release, localize and stabilize amorphous calcium, phosphate, and fluoride on the enamel surface which aids in deep mineralization of white spot lesions.
Who can participate
Age range
25 Years – 35 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 of participants:
* Presentation with at least one active WSLs on the study teeth at the start of the study.
* Good oral hygiene.
* Co-operative patients approving to participate in the trial.
* Have sufficient cognitive ability to understand consent procedures Inclusion criteria of teeth.
* Active non-cavitated initial carious lesions (ICDAS 1\&2)
* DIAGNOdent score between (8-15)
* Vital teeth with no signs or symptoms of irreversible pulpitis.
* No signs of clinical mobility.
* Teeth with healthy periodontium.
Exclusion Criteria of participants:
* Participants with parafunctional habits or bruxism.
* Participants with dry mouth.
* Participants with systemic diseases or disabilities that may affect participation.
* Heavy smoking.
* Pregnancy.
* Lack of compliance.
* Severe or active periodontal disease.
* Cognitive impairment
Exclusion criteria of teeth:
* DIAGNOdent score less than 8 and more than 15
* Untreated cavitated lesions or extensive restorations on the facial surfaces of the study teeth
* Intrinsic or extremely heavy extrinsic staining
* 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.