Effectiveness of Different Toothpastes in Treating White Spot Lesions

NCT06128434 | Unknown DMC

• 1 other identifier: M08040521
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Computerized image software analysis.
• Energy dispersive X-ray analysis.

Conditions

White Spot Lesions [Initial Caries] on Smooth Surface of Tooth

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  1) Baseline 2) 3-month evaluation 3) 6-month evaluation

Secondary Outcomes (1)

• Evaluation of the remineralizing ability of each agent

  1 month

Study Arms (3)

zinc carbonate nano-hydroxyapatite toothpaste

EXPERIMENTAL

Biorepair toothpaste with 20 wt% zinc carbonate nano-hydroxyapatite

Other: zinc carbonate nano-hydroxyapatite toothpaste

8% arginine toothpaste

EXPERIMENTAL

Colgate Sensitive Pro-Relief™ with pro-argin technology

Other: 8% arginine toothpaste

Fluoride toothpaste

ACTIVE COMPARATOR

Signal cavity fighter toothpaste with Sodium Monofluorophosphate

Other: Fluoride toothpaste

Interventions

zinc carbonate nano-hydroxyapatite toothpaste OTHER

Participants will brush their teeth with zinc carbonate nano-hydroxyapatite toothpaste twice daily.

Also known as: Biorepair

zinc carbonate nano-hydroxyapatite toothpaste

8% arginine toothpaste OTHER

Participants will brush their teeth with 8% arginine toothpaste twice daily.

Also known as: Colgate Sensitive Pro-Relief™

8% arginine toothpaste

Fluoride toothpaste OTHER

Participants will brush their teeth with Fluoride toothpaste twice daily.

Also known as: signal cavity fighter

Fluoride toothpaste

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Completion of fixed appliance therapy within the past 1 week.
• 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).

You may not qualify if:

• Previous or planned treatment of WSLs.
• Cavitated enamel surface.
• Teeth with any composite restorations, veneers, crowns.
• Surface defects (developmental defects, fluorosis, intrinsic and extrinsic discolorations, etc.).
• Smoking habits.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 30701704 BACKGROUND

• 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.

  PMID: 34451279 BACKGROUND

Central Study Contacts

Masar Mohammed Fadhle, Master degree/ Lecturer

CONTACT

01149192272; masar19h@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The toothpastes are sourced from international markets, and both the participants and the outcome assessor will remain unaware of the active remineralizing agent in the toothpaste. This ensures that neither the participants nor the outcome assessor will be informed about the assigned intervention, preventing their expectations from influencing the study results. 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized controlled trial involving 21 participants ages 12 to 18 years. They will be examined and chosen randomly for the study. Participants will be divided equally into three groups: Group 1 will use zinc carbonate nano-hydroxyapatite toothpaste twice daily; Group 2 will apply 8% arginine and calcium carbonate-containing toothpaste twice daily; and Group 3 will apply fluoridated toothpaste twice daily. Assessment of white spot lesions will be carried out using digital photographs before remineralizing agent application (baseline) and at 3, and 6 month intervals.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: November 30, 2023
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: May 14, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)