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White Spot Lesion of ToothNCT06833970

Toothpastes With Different Contents and Tooth Color

An observational study of White Spot Lesion of Tooth and Tooth Color, run by Taner OZTURK, DDS, MS at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to investigate the color tone and fluorescence changes that may occur during fixed orthodontic treatment with brackets in patients' teeth using toothpaste with different properties. Read more about this study

Who is it for?
Ages 12 to 18 yearsHealthy volunteers can take part
Conditions the study is for
White Spot Lesion of Tooth, Tooth Color, Dentistry
What is being tested?
Colgate use, Curaprox use and ROCS use
Type of treatment
Medical device
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2024to 1 Jul 2025
How long will I take part?
18 Months
Phase
Observational
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

Study population: Patients who received orthodontic treatment at Erciyes University Faculty of Dentistry

Who may be able to join

  • Patients in permanent dentition,
  • No tooth extractions planned as part of the orthodontic treatment,
  • Patients with skeletal Class I malocclusion, with an ANB angle between 0 and 4 degrees,
  • Crowding in the upper and lower dental arches ranging between 1 and 6 mm,
  • No missing teeth,
  • No structural problems on the enamel surfaces of the teeth.

Who cannot join

  • The individual has a serious systemic condition,
  • The individual shows insufficient cooperation with orthodontic treatment,
  • Inadequate maintenance of oral hygiene,
  • Individuals undergoing orthodontic treatment with removable appliances,
  • Presence of severe skeletal malocclusion,
  • Structural enamel defects, such as hypomineralization, in the teeth to be evaluated.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Erciyes University Faculty of Dentistry

    Kayseri, Kayseri, 38039

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of Color Changes in the Teeth of Individuals Using Different Toothpastes During Orthodontic Treatment

This study aims to investigate the color tone and fluorescence changes that may occur during fixed orthodontic treatment with brackets in patients' teeth using toothpaste with different properties. The study will include routinely taken three-dimensional models, fluorescence photographs, gingival index, periodontal index, ICDAS II, and DMFT index records of patients who have received orthodontic treatment at Erciyes University Faculty of Dentistry and who have been using the same toothpaste for a long time. Three different toothpaste groups were determined to be included in the study. These toothpastes will be examined in three groups: those with fluoride effect, those containing lactoperoxidase, and those without fluoride, which are routinely used by patients. It was decided that there would be 15 individuals in each group in case individuals were excluded from the clinical study to be conducted. As a result, 45 patients, 15 in each group, will be included in the study. This study will use digital models obtained by scanning the upper and lower jaws of the patients included using an intraoral scanner (3shape TRIOS). The reason for this is to evaluate whether there will be a change in the color of the patient's teeth during the orthodontic treatment process by comparing them with the records taken in the later stages of the treatment. Photographic records of the patients will also be taken with the Quantitative Laser-Induced Fluorescence (QLF) device. With this device, the fluorescence color change that occurs on the tooth surfaces will be examined.

Read the detailed description

Background

Studies examining the effectiveness of toothpastes on white spot lesions seen with fluorescence color change during orthodontic treatment are available in the literature in vitro and in vivo. Since in vivo studies are still insufficient in number, some records showing oral hygiene and periodontal health were added to the records to be taken from patients in this study. Literature studies have taken similar records, such as an in-vivo study by Hoffman et al., which evaluated the effects of two different toothpastes on white spot lesions and included plaque index and gingival index records taken from patients in 3-month periods. Another study by Kirschneck et al. investigated the effectiveness of fluoride pastes and varnishes on white spot lesions and recorded ICDAS index and gingival index values from patients at 4, 12, and 20 weeks after the beginning of treatment. Karabekiroğlu et al. compared a group using only fluoride toothpaste with a test group in which 10% casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) paste was applied topically, including records such as ICDAS 2, DMFT and DMFS index, and QLF records. In the study to be conducted, comprehensive records such as DMFT index, gingival index, plaque index, ICDAS 2 index, QLF records, and color analysis of the teeth obtained from digital models taken with the intraoral scanning device will be collected from patients at specified periods. Since the tooth color tones determined with the 3Shape Trios device, the intraoral scanning device used in the clinic, are based on the Vita scale, a reference article in the literature will be used to facilitate statistical analysis. The images of the scanning records will be transferred to Adobe Photoshop, and the color values will be converted to L.a.b. and ∆E parameters. This conversion allows for the numerical equivalent of the color tones, making statistical analysis easier. The demineralization values of 10 teeth, excluding the molars in the upper jaw, will be measured using the QLF device's own software.

Methods

The study will include routinely taken three-dimensional models, fluorescence photographs, gingival index, periodontal index, ICDAS II, and DMFT index records of patients who have received orthodontic treatment at Erciyes University Faculty of Dentistry and who have been using the same toothpaste for a long time.

Three different toothpaste groups to be included in the study were determined. These toothpastes will be examined in three groups as those routinely used by patients with fluoride effect, those containing lactoperoxidase, and those without fluoride. The number of patients in the groups was determined using the G*Power (Ver. 3.1.9.7, Heinrich Heine University, Dusseldorf, Germany) power analysis program, based on DF values of the control group followed up with standard toothpaste in a study by Bröchner et al. in 2011. According to the two-way student t-test power analysis with d=1.384 effect value, 95% power, and alpha=0.05 parameters, at least 12 individuals should be in each group. To account for possible exclusions from the clinical study, 15 individuals were included in each group. As a result, a total of 45 patients, with 15 patients in each group, will be included in the study. The patients will be randomly assigned to three groups using a free randomization program mentioned in the literature. The purpose of this method is to ensure that the distribution of the patients into groups is random. Traditionally, dental models, intraoral and extraoral photographs, radiographic images, and clinical measurement records will be taken from patients before orthodontic treatment. Digital models obtained by scanning the upper and lower jaws using an intraoral scanner (3shape TRIOS) will be used. The purpose of this is to evaluate whether there will be a change in tooth color during the orthodontic treatment process by comparing them with records taken in the later stages of treatment. Photographic records will also be taken with a Quantitative Laser-Induced Fluorescence (QLF) device, which will be used to examine fluorescence color changes on the tooth surfaces. Patients who have started their treatment after the records are taken will be divided into three groups, and each group will use the assigned toothpaste throughout the treatment. The group using only fluoride-containing toothpaste will serve as the control group. The study will evaluate upper incisors, canines, first, and second premolars. Periodontal and gingival index measurements will be taken as part of the routine examination before, during, and at the end of orthodontic treatment. ICDAS II and DMFT tooth decay presence scoring methods will be performed through intraoral examination during photo record collection.

Statistical Evaluation

Statistical evaluations will be performed with the R-based JAMOVI analysis program. Statistical comparisons of changes in the number of white spot lesions on teeth evaluated over time will be made using analysis of variance (ANOVA) for repeated measurements within each group. Suppose a statistically significant difference is observed between measurement times within each group. In that case, paired samples t-tests will be used to determine at which time points the difference is statistically significant. Whether a statistically significant difference exists between groups, between times, and in the group-time interaction will be evaluated separately using multiple analyses of variance (ANOVA). If a statistically significant difference is observed between groups or time points, Tukey HSD multiple comparison tests will be used to identify the specific differences. The statistical significance value will be set at p<0.05.

Being tested
Colgate use, Curaprox use, ROCS use, Fixed orthodontic treatment
Keywords
Tooth color change, Toothpaste, Dentifrice

What participants receive

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

  • Colgate useOther

    An evaluation of Colgate total toothpaste currently in use will be provided.

  • Curaprox useOther

    An evaluation of Curaprox toothpaste currently in use will be provided.

  • ROCS useOther

    An evaluation of ROCS toothpaste currently in use will be provided.

  • Fixed orthodontic treatmentDevice

    For standard fixed orthodontic treatment, orthodontic brackets and mechanics will be applied.

Study groups in NCT06833970
Study groupRoleWhat they receive
Group 1 ControlIndividuals using a toothpaste (Colgate) with a fluoride content of 1450 ppm, which is frequently reported in the literature and used commercially internationally, will be included. Whether the patients continue to use the relevant toothpaste will be confirmed with information provided by the patient at each session of orthodontic treatment.
Receives: Other: Colgate use; Device: Fixed orthodontic treatment
Group 2 LactoperoxidaseIndividuals using a toothpaste (Curaprox) with lactoperoxidase and content of 1450 ppm fluoride, which is frequently reported in the literature and used commercially internationally, will be included. Whether the patients continue to use the relevant toothpaste will be confirmed with information provided by the patient at each session of orthodontic treatment.
Receives: Other: Curaprox use; Device: Fixed orthodontic treatment
Group 3 Non-fluoridateIndividuals using a biocompatible mineral and natural enzyme toothpaste (ROCS) instead of the fluoride, sodium lauryl sulphate and paraben content reported in the literature and commercially used internationally will be included. Whether the patients continue to use the relevant toothpaste will be verified with the information provided by the patient at each session of orthodontic treatment.
Receives: Other: ROCS use; Device: Fixed orthodontic treatment

What is being measured

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

  1. L, a, b and ΔE parameters

    These scans were recorded using the intraoral scanning device 3Shape Trios (3Shape Trios 3 Plus, Copenhagen, Denmark). To provide numerical data for the color analysis (L, a, b, ΔE) performed, the recordings were transferred to the Adobe Photoshop program (Adobe Inc., San Jose, California, USA).

    Measured: "through study completion, an average of 1 year".

Secondary outcomes (4)
  1. ΔF and ΔFmax parameters

    The secondary outcome was that the formation (analysed by ΔF and ΔFmax parameters; loss of fluorescence) of WSLs on the buccal surfaces of the incisor, canine and premolar teeth was assessed by the QLF-D machine and software during the pre-treatment and post-treatment examination visits. QLF images were obtained to assess enamel changes in all patients pre- (T0) and post-treatment (T1).

    Measured: "through study completion, an average of 1 year".

  2. ΔQ and WS area parameters

    The secondary outcome was the development of WSLs (analysed by ΔQ and WS area parameters; with the degree of demineralization) on the buccal surfaces of the incisor, canine and premolar teeth, which was assessed by the QLF-D machine and software during the pre-treatment and post-treatment evaluations. The images were then analysed by placing an analysis patch on the stained area, ensuring that the boundaries of the patch corresponded to sound enamel.

    Measured: "through study completion, an average of 1 year".

  3. Gingival index

    The Gingival Index (GI) is a widely used clinical measure in dental research to assess the severity and presence of gingivitis (inflammation of the gums).

    Measured: "through study completion, an average of 1 year".

  4. Periodontal index

    The Periodontal Index (PI) is a clinical tool used in dental research and practice to assess the overall health of the periodontium (the supporting structures of the teeth, including the gums, periodontal ligament, cementum, and alveolar bone).

    Measured: "through study completion, an average of 1 year".

Timeline

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

  1. First posted19 Feb 2025
  2. Study start1 May 2024
  3. Primary completion24 Oct 2024
  4. Study completion1 Jul 2025

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
45 participants (actual)
Target duration
18 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06833970
Sponsor's protocol ID
2024/253
Status last verified
Sep 2025
First submitted
9 Jan 2025
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to national and local ethical rules, data is not shared.

Publications

  • Yoon HI, Bae JW, Park JM, Chun YS, Kim MA, Kim M. A Study on Possibility of Clinical Application for Color Measurements of Shade Guides Using an Intraoral Digital Scanner. J Prosthodont. 2018 Aug;27(7):670-675. doi: 10.1111/jopr.12559. Epub 2016 Nov 7.

    PubMed 29377326
  • Atilla AO, Ozturk T, Eruz MM, Yagci A. A comparative assessment of orthodontic treatment outcomes using the quantitative light-induced fluorescence (QLF) method between direct bonding and indirect bonding techniques in adolescents: a single-centre, single-blind randomized controlled trial. Eur J Orthod. 2020 Sep 11;42(4):441-453. doi: 10.1093/ejo/cjz058.

    PubMed 31375814

Questions about this trial

What is this clinical trial studying?

An observational study of White Spot Lesion of Tooth and Tooth Color, run by Taner OZTURK, DDS, MS at 1 site in Turkey (Türkiye).

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 6 inclusion and 6 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: finished, as of the sponsor's last update on 19 Sep 2025. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

L, a, b and ΔE parameters (time frame: "through study completion, an average of 1 year".). 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 NCT06833970, 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 19 Sep 2025.

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