Clinical Effectiveness of Bioactive Silica Based With Calcium Toothpaste

N/ANot Yet RecruitingNCT07120243

Rawda Hesham Abd ElAziz20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Caries; Initial Caries Active

Interventions

Toothpaste ProductPROCEDURE

Administration ofa toothpaste

Varnishes, FluoridePROCEDURE

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.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with non cavitated carious WSL in at least one upper or lower tooth. * Teeth with active non cavitated white spot carious lesions on the cervical one third of the facial or lingual surfaces. Teeth with initial carious lesions with score 1 or 2 according to The International Caries Detection and Assessment System (ICDAS). • Teeth with Diagnodent values between 14-20 that refers to early enamel caries. Exclusion Criteria: Patients with known allergies or adverse reactions to any ingredient of the tested materials. • Systematic disease and/ or physical disabilities that may affect participation. • Patients with white spots due to congenital reasons e.g. enamel hypomineralization. • Pregnant females with frequent vomiting attacks. • Smokers. • Excessive dietary or environmental exposure to acids. * Presence of surface cavitation or restorations .

Outcomes

Primary Outcomes

Degree of Remineralization efficacy by Diagnodent

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

Secondary Outcomes

Carie Progression according to International Caries Detection and Assessment System (ICDAS) scale:

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

Patient-reported outcome measures (PROMs): Patients perception of the 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".

Time frame: change from the baseline, 1month, 3 months , 6 months after treatment

Central Contacts

Rawda Hesham Abd ElAziz

CONTACT

+201001097200 rawda.hesham@dentistry.cu.edu.eg

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.