A Phase 2 interventional study of Curodont Repair and fluoride varnish in White Spot Lesion, sponsored by Cairo University. Status unknown. Open to participants aged 12 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-26.
Sponsored by Cairo University · Phase 2, Interventional, and Treatment
The aim of this study is to compare the effect of color change between remineralizing agent and guided enamel regeneration in treatment of white spot lesion after orthodontic treatments
Roles and responsibilities:
1-Intervention: A.N. will treat the lesion with 2 % NaOCl for 20 sec, then rinsed and dried. A.N. will etch the lesion with 35 % Phosphoric acid for 20 sec to open up the pores to the subsurface lesion and sub¬sequently rinsed with water for 20 sec and air-dried. A.N. will apply (CURODONT™ REPAIR,Credentis, Switzerland) for two to three minutes. A.N. will advise the patients to rinse the quadrant containing the treated teeth using chlorhexidine mouthwash (Corsodyl, Herrenberg, Germany) until Day 4 and avoid teeth brushing. At D4, A.N. will ask the patients to use a soft tooth brush and tooth paste until Day 8. At this point they will be reverted to their normal oral hygiene procedures.
2-Comparator: A.N. will apply (2.26% F, Duraphat, WoelmPharma,Gesellschaft mit beschränkter Haftung, Germany). onto the tooth surfaces with White Spot Lesions using a brush, with the applicator dabbed repeatedly onto the tooth surface without contacting soft tissues. After a few minutes, a thin and clear layer is formed. A.N. will advise the patients not to brush their teeth or chew food for at least 4 hrs after treatment; during this time, soft food and liquid might be consumed.
3-Outcomes:
Patient satisfaction:
H.F.\& A.R will measure patient satisfaction using Visual Analogue Scale scores. The mean and standard deviation for the VAS scores of the patients recorded preoperatively, at the time of materials application, 3,6 months review for aesthetics
H.F.\& A.R will perform visual color evaluation using the Vita Easyshade Compact (Vita Zahnfabrik, Bad Sa¨ckingen,Germany).
The shade tab may now be measured by holding the probe tip at 90° to surface at the middle 1/3 of the tab, pressing the measurement button on the Hand Piece, and waiting until the Easyshade "beeps" to indicate successful completion of the measurement H.F.\& A.R will hold the probe tip 90ᴼ to the WSL on tooth surface and pressing the measurement bottom on the hand piece and waiting until the easyshade beeps to indicate successful completion of the measurement , Three images will be captured for each tooth at each time point, and the average values for L* (lightness, achromatic color coordinate), a* (green/red coordinate), b* (blue/yellow coordinate), and the resultant color difference (ϪE*) over the three measurements will be calculated H.F.\& A.R will perform the visual color assessments at baseline (T0) to record the color characteristics of the WSLs immediately after treatment, (T1) to record the color characteristics of the WSL after 3 months, (T2) to record the color characteristics of the WSL after 6 months. The instrumental color measurements will be performed using the Commission International de I'Eclariage (CIE) L*a*b* color notation system (CIELAB).
Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.
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Exclusion Criteria:
curodont repair is a biomimetic regeneration scaffold for remineralization
Drug: Curodont Repair · Drug: fluoride varnish
fluoride varnish inhibit progression of white spot lesion
Drug: Curodont Repair · Drug: fluoride varnish
composed of biomimetic regeneration scaffold self-assembling peptides (P11-4) used for remineralization
Also known as: CURODONT™ REPAIR,Credentis, Switzerland
fluoride inhibit the progression of white spot lesion
Also known as: 2.26% F, Duraphat, WoelmPharma GmbH, Germany
change in patient satisfaction
using visual analogue scale from 0-100 (0= not satisfied , 100= totally satisfied)
Time frame: before, after 3 and 6 months
change in color shade
will use vita easy shade devise
Time frame: before, after 3 and 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jan 2017, a primary completion of Jul 2017 and a completion of Sep 2017. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium Fluoride