Toothpastes With Different Contents and Tooth Color

NCT06833970 | Completed

• 1 other identifier: 2024/253
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

White Spot Lesion of Tooth; Tooth Color; Dentistry; Orthodontic Appliances, Fixed

Keywords

Tooth color change; Toothpaste; Dentifrice

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (4)

• ΔF and ΔFmax parameters

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

• ΔQ and WS area parameters

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

• Gingival index

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

• Periodontal index

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

Study Arms (3)

Group 1 Control

Individuals 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.

Other: Colgate use; Device: Fixed orthodontic treatment

Group 2 Lactoperoxidase

Individuals 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.

Other: Curaprox use; Device: Fixed orthodontic treatment

Group 3 Non-fluoridate

Individuals 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.

Other: ROCS use; Device: Fixed orthodontic treatment

Interventions

Colgate use OTHER

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

Group 1 Control

Curaprox use OTHER

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

Group 2 Lactoperoxidase

ROCS use OTHER

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

Group 3 Non-fluoridate

Fixed orthodontic treatment DEVICE

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

Group 1 Control; Group 2 Lactoperoxidase; Group 3 Non-fluoridate

Eligibility Criteria

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

Study Population

Patients who received orthodontic treatment at Erciyes University Faculty of Dentistry

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taner OZTURK, DDS, MS: lead

Study Sites (1)

Erciyes University Faculty of Dentistry

Kayseri, Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 29377326 BACKGROUND

• 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.

  PMID: 31375814 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: February 19, 2025
• Study Start: May 1, 2024
• Primary Completion: October 24, 2024
• Study Completion: July 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)