About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Participants with parafunctional habits or bruxism.
Participants with dry mouth.
Participants with systemic diseases or disabilities that may affect participation.
Heavy smoking.
Trial design
Parallel
Treatments tested in this trial
Moringa Oleifera
Other interventionMoring Oleifera Varnish application Using a disposable bond brush, the varnish will be painted on the diagnosed surfaces, then the patient will be instructed to avoid brushing or flossing and to avoid hard and sticky food or any products that may contain alcohol (oral rinses, beverages, etc.) for the next 4 hours after application.
Varnish
Other interventionMI Varnish application The varnish will be applied on the clean surfaces according to manufacturer instructions as follows: 1. The foil cover of the MI Varnish unit dosage bottle will be peeled-off and MI Varnish will be stirred with the disposable brush before application. 2. The surfaces will be covered with a thin uniform layer using a disposable bond brush to avoid clumping. 3. The area will be allowed to become wet to ensure the setting of the varnish.
Treatment groups
Trial outcomes
Primary outcomes
Remineralization efficacy
The DIAGNOdent will be used to quantify objectively the white spot lesions. For every patient, measurements with the DIAGNOdent will be performed and calibrated on a sound enamel (incisal one third of the central incisor) before actual readings. The teeth will be scanned carefully with the tip held in contact with the tooth surface and tilted around the measuring site so that fluorescence could be collected from all directions. Maximum reading will be recorded Singh et al.,(2016). DIAGNOdent scores: Shalaan et al.,(2023) * Score 1: 0-4 (healthy tooth structure) * Score 2: 5-10 (outer half enamel caries) * Score 3: 11-20 (inner half enamel caries) * Score 4: 21+ (dentin caries).
Secondary outcomes
Caries lesion activity assessment
Nyvad criteria will be used to detect the carious lesion activity. The Nyvad criteria are visual tactile caries classification system which can assess the caries activity and severity. Nyvad criteria includes all stages of caries from clinically sound surfaces to non-cavitated carious lesions and microcavitated lesions in enamel up to frank cavitations in dentine Nyvad and Baelum (2018). Lesion activity can be detected through surface topography and texture; an active lesion in enamel is rough upon probing with the tip of a ball ended probe, unlike the inactive lesion which appears to be shiny and smooth upon probing. These surface phenomena are the visual representation of the demineralization activity of the dental biofilm. Due to scattering of light, rough active non-cavitated enamel lesions appear dull to the naked eye, unlike the surfaces of inactive lesions which appears glossy due to specular reflection. Nyvad and Baelum (2018).
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