An interventional study of zinc carbonate nano-hydroxyapatite toothpaste and 8% arginine toothpaste in White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-14.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
This randomized clinical trial and laboratory study was conducted to:
Compare the effectiveness of zinc-carbonated nano-hydroxyapatite, arginine, and fluoride-containing toothpastes for treating white spot lesions associated with orthodontically treated teeth by using:
White spot lesions (WSLs), defined as "white opacity," occur as a result of subsurface enamel demineralization that is located on smooth surfaces of teeth. The reason for the white appearance is the changes in light-scattering optical properties of the decalcified enamel. The aim of the current study is to compare the effectiveness of zinc-carbonated nano-hydroxyapatite, arginine, and fluoride-containing toothpastes for treating white spot lesions.
A) Primary Objective
Assessment of:
size and color change measurements of the WSLs through digital photography and computerized image software analysis.
B) Secondary Objectives
Assessment of:
PICOTS:
I - Intervention:
C- Comparison:
fluoride-containing toothpaste.
O -Outcomes:
T- Time: study period will be over 6 months.
S- Study design: Randomized Controlled Trial (RCT) and in vitro study
This study will consist of two parts: in vivo part (Randomized Controlled Trial) and in vitro part:
In vivo part:
Patients will be randomly allocated into one of the three groups (7/each):
Group 1: zinc-carbonated nano-hydroxyapatite containing toothpaste (study group) Group 2: 8% arginine and calcium carbonate (Pro-Argin) containing toothpaste (study group) Group 3: fluoride containing toothpaste (positive control group)
Materials used in the study:
fluoride containing toothpaste
All interventions will be performed by the primary investigator as follows:
The dental plaque deposit will to be removed before the assessment. Dental prophylaxis will be performed with a bristle brush and non-fluoridated prophylactic paste during the initial clinical examination and before any examination.
photographic assessment by digital camera will be performed at 0 , 3 months, and 6 months throughout the study period for all the patients. During the photographic assessment, all the photographs will be taken under fixed conditions using a digital camera with lens equipped with external ring flash with 1:1 shooting power. the image quality will be set as RAW format, the shutter speed will set to 1/125 sec, F22 aperture value, auto white balance, and ISO 200. All images will be saved as Joint Photographic Experts Group (JPEG) files suitable for manipulation with the image analysis software.
At the baseline of the study, all participants will be provided with instructions to adhere to strict oral hygiene practices. These instructions included brushing their teeth twice a day using the allocated toothpaste and a soft-bristle toothbrush, employing the Bass Technique for a duration of 1 to 2 minutes.Participants will be instructed to spit out the excess toothpaste rather than rinse their mouths with water after brushing with toothpaste.
Patient's confidentiality will be respected through the photographic technique.
After digital images captured, they will be downloaded and stored as JPEG. Then the size of each WSL will be analyzed, and compared with baseline lesions by using Abode Photoshop and ImageJ analysis softwares.
The enamel color of each WSL will be measured using the Standardized CIE Lab* system (Commission International de l'Eclairage) within Adobe Photoshop software.
All measurements will be performed under standardized ambient conditions to ensure accuracy and reproducibility.
Patients will be recalled after 1, 3, and 6 months for clinical examinations and photographic assessments and oral hygiene instructions will be further provided.
Photographic assessment for size and color change reading outcomes will be assessed by one calibrated examiners at the following periods:
Photographic assessment:
The following will be determined from photographs of all the patients in relation to WSLs:
Color change will be calculated as the color difference between the treated and untreated enamel, as well as the color difference between the WSL at baseline and at the different follow-up intervals.
14 image will be re-examined after 1 weeks for intra-examiner reliability
in-vitro part: experimental study where a total of 36 sound premolars will be randomly allocated according to the assigned toothpaste into four groups: G1: zinc-carbonated nano-hydroxyapatite; G2: arginine; G3: positive control (fluoride toothpaste); and G4: negative control (artificial saliva). A scanning electron microscope (SEM) and energy dispersive X-ray (EDX) analysis will be conducted at the baseline to assess the calcium (Ca) and phosphorus (P) content. Following the induction of white spot lesions, a pH cycle will be implemented, involving a 7-day application of the toothpastes. Readings will be taken both after demineralization and subsequent remineralization phases.
Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biorepair toothpaste with 20 wt% zinc carbonate nano-hydroxyapatite
Other: zinc carbonate nano-hydroxyapatite toothpaste
Colgate Sensitive Pro-Relief™ with pro-argin technology
Other: 8% arginine toothpaste
Signal cavity fighter toothpaste with Sodium Monofluorophosphate
Other: Fluoride toothpaste
Participants will brush their teeth with zinc carbonate nano-hydroxyapatite toothpaste twice daily.
Also known as: Biorepair
Participants will brush their teeth with 8% arginine toothpaste twice daily.
Also known as: Colgate Sensitive Pro-Relief™
Participants will brush their teeth with Fluoride toothpaste twice daily.
Also known as: signal cavity fighter
the size
Photographic assessment of the images will be done for quantifying the size (in mm2) of the white spot lesions and the affected tooth's labial surface by using an image processing software, ImageJ analysis software and to ensure accuracy of values, image calibration will be carried out, and the scale of the image analysis software will be pre-set. After the software calculates the values of the entire area of the tooth and the size of the WSL, the area affected by white spot lesions will be expressed as a percentage of the total tooth surface: WSLs %= Area of WSL/ Area of the labial tooth surface\*100.
Time frame: 1) Baseline 2) 3-month evaluation 3) 6-month evaluation
the color change
Using the Standardized CIE Lab\* system within Adobe Photoshop software, L\*a\*b values will be analyzed for each tooth and the color changes between carious and healthy enamel (∆E\*ab), as well as changes between different time points (∆E\*ab), will be calculated by = Δ E = (Δ L 2 + Δ a2 + Δ b2) ½. ΔE values between 1 and 3.7 are not only acceptable but also often go unnoticed in various colors, especially darker shades. Conversely, when ΔE exceeds 3.7, the color change could be clinically visible, indicating a noticeable color mismatch. According to the degrees of color changes evaluated 6 months after treatment, the teeth will be divided into the following three types: Type 1: The whitish, opaque color is completely masked Type 2: The whitish opaque color is partially masked but not completely Type 3: The whitish opaque color shows little
Time frame: 1) Baseline 2) 3-month evaluation 3) 6-month evaluation
Evaluation of the remineralizing ability of each agent
assessing Calcium (Ca) and Phosphorus (P) in weight percentage and Ca/P ratio for all groups by using Energy dispersive X-ray Spectroscopy (EDX) Analysis
Time frame: 1 month
Plan to share: No
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Mansoura University