Aesthetic Efficacy of Resin Infiltration Using Different Conditioning Methods: 24-Month Results

NCT06259214 | Completed

• 1 other identifier: 1700213
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To assess color and fluorescence changes in white spot lesions (WSLs) using different surface conditioning methods prior to resin infiltration: 24-months follow-up Methods: Thirty patients with each at minimum four WSLs after bracket debonding were included. After baseline fluorescence and color measurements, the lesions were randomly divided into four groups (n = 30): G1 (control): regular brushing, G2: 15% HCl gel (Icon Etch), G3: 37% H3PO4 gel (Scotchbond Etchant), G4: Er:YAG laser (Fotona AT Fidelis III). The lesions were desiccated with Icon Dry and then Icon Infiltrant (DMG) was applied. In the treatment groups, color and fluorescence were examined at baseline (T0), just after the resin infiltration treatment (T1), and after 6 (T2) and 24 months (T3). In the control group, the examinations were performed at baseline (T0) and after 6 (T2) and 24 months (T3).

Conditions

White Spot Lesion

Keywords

Color stability; Fluorescence; Resin infiltration; White spot lesion

Outcome Measures

Primary Outcomes (2)

• color change

  A spectrophotometer (SpectroShade; Medical High Technologies, Italy) was used to measure color parameters. The spectrophotometer was calibrated before the measurements of each specimen using a standard white background. The mouth piece attached to the intraoral camera of the spectrophotometer was placed at 90° on the alveolar process above each tooth. After correct placement of the optic handpiece, the examiner checked that the tooth appeared in the center of the yellow target box on the computer screen, and the opposing teeth, the tongue, and lips were not visible on the screen. The results from each tooth obtained by spectrophotometer were recorded, with the mean values of L\*, a\*, and b\* automatically calculated at three consecutive times by positioning the intraoral camera, removing it, and then repositioning it. Three consecutive readings were taken using the spectrophotometer and the mean values were recorded.Higher values indicate more color change.

  24 month

• fluorescence loss

  DIAGNOdent Pen 2190 (Kavo, Biberach, Germany) was used to score each lesion . Before every scoring session, the device was calibrated using the standard ceramic according to the manufacturer's instructions. The teeth were rinsed and air dried before registration and a type B probe tip was positioned on the buccal surface of the tooth and rotated around its vertical axis until the peak reading was displayed on the panel. All measurements were taken 3 times and the average fluorescence value was recorded. Higher DIAGNOdent Pen values indicate deeper caries and the difference between the values obtained at different time intervals and the initial value indicates the amount of change in the loss of fluorescence of the lesions

  24 monrth

Study Arms (4)

regular brushing

NO INTERVENTION

regular brushing

15% HCl gel

ACTIVE COMPARATOR

15% HCl gel (Icon Etch, DMG, Hamburg, Germany) was applied to the WSLs for 2 min, followed by water rinsing and drying with compressed air (each for 30 s)

Other: 15% HCl gel

37% H3PO4 gel

ACTIVE COMPARATOR

37% H3PO4 gel (Scotchbond Etchant, 3M ESPE, St. Paul, MN, USA) was applied to the WSLs for 30 s, which were then water rinsed and dried with compressed air (each for 30 s)

Other: H3PO4 gel

Er:YAG laser

ACTIVE COMPARATOR

Er:YAG laser (Fotona AT Fidelis III, Ljubljana, Slovenia) was applied for 10 s with the following operating parameters: energy 300 mJ, frequency 10 Hz, wavelength 2.94 μm, short pulses of 10 pulses per second, pulse time 180 ms, distance 1 mm away from lesion, water spray cooling 80%.

Other: Er:YAG laser

Interventions

15% HCl gel OTHER

Icon , DMG, Hamburg, Germany

15% HCl gel

H3PO4 gel OTHER

Scotchbond Etchant, 3M ESPE, St. Paul, MN, USA

37% H3PO4 gel

Er:YAG laser OTHER

Fotona AT Fidelis III, Ljubljana, Slovenia

Er:YAG laser

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• at least four white spot lesions on the buccal surfaces after bracket debonding

You may not qualify if:

• any systemic disease bad oral hygiene smoking habit enamel hypoplasia staining fluorosis restoration or cavity in any teeth with white spot lesions

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Emel Karaman

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (9)

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  PMID: 21536209 BACKGROUND

• Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.

  PMID: 21208070 BACKGROUND

• Ogaard B. Prevalence of white spot lesions in 19-year-olds: a study on untreated and orthodontically treated persons 5 years after treatment. Am J Orthod Dentofacial Orthop. 1989 Nov;96(5):423-7. doi: 10.1016/0889-5406(89)90327-2.

  PMID: 2816842 BACKGROUND

• Bergstrand F, Twetman S. A review on prevention and treatment of post-orthodontic white spot lesions - evidence-based methods and emerging technologies. Open Dent J. 2011;5:158-62. doi: 10.2174/1874210601105010158. Epub 2011 Sep 16.

  PMID: 21966335 BACKGROUND

• Dogra S, Goyal V, Gupta A, Joshi S, Kataria V, Saini J, Nagpal M, Narula P. Spectrophotometric Evaluation of Color Change in Tooth Enamel Defects Using Resin Infiltrate: An In Vivo Study. Int J Clin Pediatr Dent. 2020 Mar-Apr;13(2):150-154. doi: 10.5005/jp-journals-10005-1727.

  PMID: 32742092 BACKGROUND

• Faghihian R, Shirani M, Tarrahi MJ, Zakizade M. Efficacy of the Resin Infiltration Technique in Preventing Initial Caries Progression: A Systematic Review and Meta-Analysis. Pediatr Dent. 2019 Mar 15;41(2):88-94.

  PMID: 30992105 BACKGROUND

• Neuhaus KW, Graf M, Lussi A, Katsaros C. Late infiltration of post-orthodontic white spot lesions. J Orofac Orthop. 2010 Nov;71(6):442-7. doi: 10.1007/s00056-010-1038-0. Epub 2010 Nov 17. English, German.

  PMID: 21082307 BACKGROUND

• Patcas R, Zinelis S, Eliades G, Eliades T. Surface and interfacial analysis of sandblasted and acid-etched enamel for bonding orthodontic adhesives. Am J Orthod Dentofacial Orthop. 2015 Apr;147(4 Suppl):S64-75. doi: 10.1016/j.ajodo.2015.01.014.

  PMID: 25836346 BACKGROUND

• Youssef A, Farid M, Zayed M, Lynch E, Alam MK, Kielbassa AM. Improving oral health: a short-term split-mouth randomized clinical trial revealing the superiority of resin infiltration over remineralization of white spot lesions. Quintessence Int. 2020;51(9):696-709. doi: 10.3290/j.qi.a45104.

  PMID: 32901234 BACKGROUND

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof. Emel Karaman

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 14, 2024
• Study Start: January 6, 2017
• Primary Completion: January 6, 2019
• Study Completion: April 6, 2020
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)