Effectiveness of Different Toothpastes in Treating White Spot Lesions
NCT ID: NCT06128434
Last Updated: 2024-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
21 participants
INTERVENTIONAL
2023-11-30
2025-04-01
Brief Summary
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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:
* Computerized image software analysis.
* Energy dispersive X-ray analysis.
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Detailed Description
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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:
* Degree of remineralization using Energy dispersive X-ray analysis
PICOTS:
• P - Participants: patients in the age group of 12-18 years having post orthodontic white spot lesions (WSLs).
I - Intervention:
* zinc-carbonated nano-hydroxyapatite-containing toothpaste.
* 8% arginine and calcium carbonate-containing toothpaste (Pro-Argin technology)
C- Comparison:
fluoride-containing toothpaste.
O -Outcomes:
* Reduction in WSLs size and color improvement
* remineralization of WSLs by regaining Ca and P ions.
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:
* Study design: Randomized controlled trial (RCT)
* Grouping:
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:
1. zinc-carbonated nano-hydroxyapatite containing toothpaste.
2. 8% arginine and calcium carbonate (Pro-Argin) containing toothpaste
3. fluoride containing toothpaste
\- Clinical procedures:
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.
\- Follow up
Patients will be recalled after 1, 3, and 6 months for clinical examinations and photographic assessments and oral hygiene instructions will be further provided.
\- Outcome measurement:
Photographic assessment for size and color change reading outcomes will be assessed by one calibrated examiners at the following periods:
1\) Baseline 2) 3-month evaluation 3) 6-month evaluation
Photographic assessment:
The following will be determined from photographs of all the patients in relation to WSLs:
* Size readings The area of the labial surface of the tooth WSL area The area of WSL to area of the labial surface of the tooth ratio percent (Percent of WSL) The percentage of decrease in WSL ratio due to time (Percent Decrease)
* Color change readings The values of L\* (differences in lightness ranging from O (black) to 100 (white)), a\* (green-red coordinate), and b\* (blue yellow coordinate) will be recorded for the WSL and the adjacent sound enamel.
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.
\- Degree of WSL masking after the treatment will be measured.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The examiner was blinded to participants' codes and previous WSL scores during dental assessments. However, blinding to the type of toothpaste used was not possible. Blinding during image analysis was also unfeasible, but this limitation was deemed manageable since the outcome relied on objective computer-based data, minimizing potential bias
Study Groups
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zinc carbonate nano-hydroxyapatite toothpaste
Biorepair toothpaste with 20 wt% zinc carbonate nano-hydroxyapatite
zinc carbonate nano-hydroxyapatite toothpaste
Participants will brush their teeth with zinc carbonate nano-hydroxyapatite toothpaste twice daily.
8% arginine toothpaste
Colgate Sensitive Pro-Relief™ with pro-argin technology
8% arginine toothpaste
Participants will brush their teeth with 8% arginine toothpaste twice daily.
Fluoride toothpaste
Signal cavity fighter toothpaste with Sodium Monofluorophosphate
Fluoride toothpaste
Participants will brush their teeth with Fluoride toothpaste twice daily.
Interventions
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zinc carbonate nano-hydroxyapatite toothpaste
Participants will brush their teeth with zinc carbonate nano-hydroxyapatite toothpaste twice daily.
8% arginine toothpaste
Participants will brush their teeth with 8% arginine toothpaste twice daily.
Fluoride toothpaste
Participants will brush their teeth with Fluoride toothpaste twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of at least one post-orthodontic white spot lesion on the labial surfaces of the six maxillary anterior teeth with a score of 1 or 2 on International Caries Detection and Assessment System (ICDAS II).
Exclusion Criteria
* Cavitated enamel surface.
* Teeth with any composite restorations, veneers, crowns.
* Surface defects (developmental defects, fluorosis, intrinsic and extrinsic discolorations, etc.).
* Smoking habits.
12 Years
18 Years
ALL
Yes
Sponsors
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Mansoura University
OTHER
Responsible Party
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Locations
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Mansoura University
Al Mansurah, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Role: primary
References
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Schlagenhauf U, Kunzelmann KH, Hannig C, May TW, Hosl H, Gratza M, Viergutz G, Nazet M, Schamberger S, Proff P. Impact of a non-fluoridated microcrystalline hydroxyapatite dentifrice on enamel caries progression in highly caries-susceptible orthodontic patients: A randomized, controlled 6-month trial. J Investig Clin Dent. 2019 May;10(2):e12399. doi: 10.1111/jicd.12399. Epub 2019 Jan 30.
Butera A, Pascadopoli M, Gallo S, Lelli M, Tarterini F, Giglia F, Scribante A. SEM/EDS Evaluation of the Mineral Deposition on a Polymeric Composite Resin of a Toothpaste Containing Biomimetic Zn-Carbonate Hydroxyapatite (microRepair(R)) in Oral Environment: A Randomized Clinical Trial. Polymers (Basel). 2021 Aug 16;13(16):2740. doi: 10.3390/polym13162740.
Other Identifiers
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M08040521
Identifier Type: -
Identifier Source: org_study_id
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