Clinical Effectiveness of Bioactive Silica Based With Calcium Toothpaste

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-55
SponsorRawda Hesham Abd ElAziz

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Presence of surface cavitation or restorations .

Trial design

Design model

Parallel

Treatments tested in this trial

  • Toothpaste Product

    Procedure/Surgery

    Administration ofa toothpaste

  • Varnishes, Fluoride

    Procedure/Surgery

    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.

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: Group 1 Refix Booster: Bioactive Silica Based (Refix technology) with calcium booster toothpasteExperimental treatment 1 intervention
Group B: Group 2 Polimo: 5% Sodium Fluoride varnishExperimental treatment 1 intervention
Group C: Group (3) Signal Complete 8 ; Conventional 1425 ppm fluoride toothpaste:Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Rawda Hesham Abd ElAziz

Lead sponsor

Cairo University

Sponsor institution

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