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White Spot Lesions [Initial Caries] on Smooth Surface of ToothNCT06128434

Effectiveness of Different Toothpastes in Treating White Spot Lesions

A study testing zinc carbonate nano-hydroxyapatite toothpaste, 8% arginine toothpaste and Fluoride toothpaste in people with White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, run by Mansoura University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 18 yearsHealthy volunteers can take part
What is being tested?
zinc carbonate nano-hydroxyapatite toothpaste, 8% arginine toothpaste and Fluoride toothpaste
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteEgypt
Study dates
30 Nov 2023to 1 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Masar Mohammed Fadhle, Master degree/ Lecturer contact

01149192272 ext. 002

masar19h@gmail.com

Egypt1 site, 1 recruiting
  • Mansoura University

    Al Mansurah, 35516

    01149192272, masar19h@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Clinical and Laboratory Effectiveness of Different Toothpastes in Treating White Spot Lesions

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.
Read the detailed description

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.

  1. Primary Objective

Assessment of:

size and color change measurements of the WSLs through digital photography and computerized image software analysis.

  1. 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.

Being tested
zinc carbonate nano-hydroxyapatite toothpaste, 8% arginine toothpaste, Fluoride toothpaste

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • zinc carbonate nano-hydroxyapatite toothpasteOther

    Also called Biorepair

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

  • 8% arginine toothpasteOther

    Also called Colgate Sensitive Pro-Relief™

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

  • Fluoride toothpasteOther

    Also called signal cavity fighter

    Participants will brush their teeth with Fluoride toothpaste twice daily.

Study groups in NCT06128434
Study groupRoleWhat they receive
zinc carbonate nano-hydroxyapatite toothpasteExperimentalBiorepair toothpaste with 20 wt% zinc carbonate nano-hydroxyapatite
Receives: Other: zinc carbonate nano-hydroxyapatite toothpaste
8% arginine toothpasteExperimentalColgate Sensitive Pro-Relief™ with pro-argin technology
Receives: Other: 8% arginine toothpaste
Fluoride toothpasteActive comparatorSignal cavity fighter toothpaste with Sodium Monofluorophosphate
Receives: Other: Fluoride toothpaste

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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

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

Secondary outcomes (1)
  1. 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

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start30 Nov 2023
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06128434
Sponsor's protocol ID
M08040521
Status last verified
Nov 2023
First submitted
7 Nov 2023
Last updated
14 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30701704
  • 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.

    PubMed 34451279

Questions about this trial

What is this clinical trial studying?

A study testing zinc carbonate nano-hydroxyapatite toothpaste, 8% arginine toothpaste and Fluoride toothpaste in people with White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Masar Mohammed Fadhle, Master degree/ Lecturer (01149192272 ext. 002, masar19h@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the size (time frame: 1) Baseline 2) 3-month evaluation 3) 6-month evaluation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06128434, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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