Toothpaste Product
ProcedureAdministration ofa toothpaste
NCT Number: NCT07120243
This study will be conducted to Clinically evaluate Bioactive Silica Based with calcium booster (Refix technology) toothpaste and Sodium Fluoride varnish versus conventional fluoride toothpastes in management of white spot lesions of adult patients over 6m follow up and evaluating patient perception regarding the treatment provided.
Trial opening soon.
Get Notified22 year–55 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Teeth with initial carious lesions with score 1 or 2 according to The International Caries Detection and Assessment System (ICDAS).
Exclusion criteria
Patients with known allergies or adverse reactions to any ingredient of the tested materials.
Administration ofa toothpaste
The tooth will be dried, and cotton roll isolated. According to manufacturer instructions, thin coat of the varnish will be applied on the teeth for 10 - 20 s using a microbrush in a horizontal sweeping motion , then drying with air will be done.
Time frame: change from the baseline, 1month, 3 months , 6 months after treatment
DIAGNOdent calibration will be performed first then the tip of the probe will be positioned on the lesion and rotated around its vertical axis until the highest value will be reached and a peak reading will be recorded
Time frame: change from the baseline, 1month, 3 months , 6 months after treatment
The tooth will be visually examined according to the ICDAS scale as follows: "Code 0: Sound tooth surface: There should be no evidence of caries.
Code 1: First visual change in enamel: When seen wet there is no evidence of any change in color attributable to carious activity, but after prolonged air drying a carious opacity (white or brown lesion) is visible that is not consistent with the clinical appearance of sound enamel.
Code 2: Distinct visual change in enamel when viewed wet: There is a carious opacity or discoloration (white or brown lesion) that is not consistent with the clinical appearance of sound enamel. This lesion may be seen directly when viewed from the buccal or lingual direction. In addition, when viewed from the occlusal direction, this opacity or discoloration may be seen as a shadow confined to enamel, seen through the marginal ridge.
Code 3: Initial breakdown in enamel due to caries with no visible dentin: Once dried for approximately five seconds there is disti
Time frame: change from the baseline, 1month, 3 months , 6 months after treatment
Patients will be evaluated regarding their perception of the treatment provided outcome using Global Impression of Change Questionnaire (GICQ) which is a seven-point scale describing the overall impression of the patients toward the treatment of the lesions and change from the baseline as follows: 'very much worse', 'worse', 'a little worse', 'unchanged', 'a little better', 'better', 'very much better'. satisfied".
Contact information is provided by the study sponsor or research team.
Rawda Hesham Abd ElAziz
Other
Clinical Effectiveness of Bioactive Silica Based With Calcium Toothpaste, Sodium Fluoride Varnish in Management of White Spot Lesions (A 6m Randomized Clinical Trial).
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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