White Spot LesionNCT06259214
Aesthetic Efficacy of Resin Infiltration Using Different Conditioning Methods: 24-Month Results
A study testing 15% HCl gel, H3PO4 gel and Er:YAG laser in people with White Spot Lesion, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- 15% HCl gel, H3PO4 gel and Er:YAG laser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2017to 6 Apr 2020
- 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 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- at least four white spot lesions on the buccal surfaces after bracket debonding
Who cannot join
- any systemic disease bad oral hygiene smoking habit enamel hypoplasia staining fluorosis restoration or cavity in any teeth with white spot lesions
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
Prior to the study an experienced investigator (EK) attended a training and calibration session (k value = 0.88) and evaluated the severity of WSLs under direct illumination using a dental lamp with the aid of a standard 3.0× loupe (Keeler, Windsor, UK). Isolation was achieved with a cotton roll and suction. For the visual severity evaluation, all teeth were cleaned and air dried for 5 s and each lesion was scored according to ICDAS II free smooth-surface criteria [20]. Lesions with code 1 (first visual change after prolonged air drying) and code 2 (distinct visual changes without air drying) were included. The teeth were cleaned with a rubber cup and pumice, rinsed, and air dried (each for 30 s).
The same investigator (EK) used a DIAGNOdent Pen 2190 (Kavo, Biberach, Germany) to score each lesion afterwards. 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.
Out of 40 consecutive patients between 14 and 21 years of age who had just finished their fixed orthodontic treatment, 4 patients declined to participate in the trial and 6 patients did not meet the inclusion criteria, and 30 patients (18 females, 12 males, aged 15-19 years, mean age 17.1 years) with at least four WSLs on the buccal surfaces after bracket debonding were included in the trial. Patients with any systemic disease, bad oral hygiene, a smoking habit, enamel hypoplasia, staining, fluorosis, or restoration or cavity in any teeth with WSLs were excluded from the study. At the end of the clinical examination a total of 120 non-cavitated, unrestored WSLs after multibracket treatment on the buccal surfaces of the anterior and premolar teeth in the upper and lower jaws of 30 patients were included.
A spectrophotometer (SpectroShade; Medical High Technologies, Italy) was used to measure color parameters in the same examination room with standardized light conditions. 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.
Treatment
After rubber dam placement, the lesions of each patient were randomly divided into 4 groups (n = 30):
G1 (control): The control group received no treatment except regular brushing, G2: 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).
G3: 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).
G4: An 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%.
The lesions were desiccated with ethanol (Icon Dry, DMG, Hamburg, Germany) and air dried for 30 s. Then resin infiltrant (Icon Infiltrant, DMG, Hamburg, Germany) was applied to the tooth surface and allowed to penetrate for 3 min. A cotton roll was used to wipe excess material from the surface, and the material then was light cured for 40 s with an LED device (EliparTM S10; 3M ESPE, St. Paul, MN, USA) with 1200 mW/cm2 light intensity in standard continuous mode. The clinician repeated the infiltration step for 1 min to infiltrate any remaining porosities. Dental floss was used to remove any excess resin from the proximal areas. Then polishing was conducted with Sof-Lex disks (3M ESPE, St. Paul, MN, USA) using a slow-speed handpiece. The disks were used in a decreasing sequence of granulation and each disk was used for 5 s. The same clinician (KAU) conducted all restorative procedures.
All patients were given oral hygiene instructions and oral hygiene packages, which included a toothbrush (Oral B, Advantage Sensitive, P\&G Oral Health Care, Mason, OH, USA), fluoride toothpaste (Pro-Expert Professional Protection, Ipana, Gross-Gerau, Germany), and dental floss (Oral B, Essential floss, P\&G Oral Health Care, Mason, OH, USA). The patients were asked not to use any other dental products during the study period and the oral hygiene packages were renewed every 2 months.
Follow up examination All patients attended the follow-up visits. New caries formation was evaluated during the follow-ups. In the treatment groups the DIAGNOdent Pen and spectrophotometer examinations were performed at baseline (T0), just after the resin infiltration treatment (T1), and after 6 (T2) and 24 months (T3). In the control group, the DIAGNOdent Pen and spectrophotometer examinations were performed at baseline (T0) and after 6 (T2) and 24 months (T3). Fluorescence and color values were recorded as previously described by the same investigator (EK), who was blinded regarding the treatment group allocation of the teeth.
The differences in fluorescence and color values were evaluated by taking into account the differences between the initial values and the values at the different evaluation times. L*, a*, and b* were measured each time, and the changes in them (ΔL, Δa, and Δb) were calculated. The L*-axis indicates how light a sample is (0 is black and 100 is white). The red/green axis is represented by the a*-value, with an increase meaning a higher red color component. The yellow/blue axis is represented by the b*-value, with an increase meaning higher yellow color. The color change ΔE<3.7 is considered a clinically acceptable color difference [9] and ΔE for each tooth was calculated as follows:
ΔE= [(ΔL)2+ (Δa)2+ (Δb)2]1/2 Statistical analysis The normality of the variables was evaluated with the Kolmogorov-Smirnov test and the homogeneity of the variances was evaluated with the Levene test. Variables were summarized as median [25th-75th percentile] values. In the variables that met the parametric test assumptions, the differences between groups and within groups were tested with analysis of variance in repeated measurements. The Bonferroni test was used for pairwise comparisons. In the variables that did not meet the parametric test assumptions, the differences between the groups were determined with the Friedman test and the differences between the groups were determined with the Kruskal-Wallis test. In the event of a difference, pairwise comparisons were conducted with Dunn's test.
- Conditions
- White Spot Lesion
- Being tested
- 15% HCl gel, H3PO4 gel, Er:YAG laser
- Keywords
- Color stability, Fluorescence, Resin infiltration, White spot lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15% HCl gelOther
Icon , DMG, Hamburg, Germany
H3PO4 gelOther
Scotchbond Etchant, 3M ESPE, St. Paul, MN, USA
Er:YAG laserOther
Fotona AT Fidelis III, Ljubljana, Slovenia
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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%. Receives: Other: Er:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 24 monrth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start6 Jan 2017
- Primary completion6 Jan 2019
- Study completion6 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for White Spot LesionStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Emel Karaman, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259214
- Sponsor's protocol ID
- 1700213
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Richter AE, Arruda AO, Peters MC, Sohn W. Incidence of caries lesions among patients treated with comprehensive orthodontics. Am J Orthod Dentofacial Orthop. 2011 May;139(5):657-64. doi: 10.1016/j.ajodo.2009.06.037.
PubMed 21536209Tufekci 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.
PubMed 21208070Ogaard 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.
PubMed 2816842Bergstrand 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.
PubMed 21966335Dogra 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.
PubMed 32742092Faghihian 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.
PubMed 30992105Neuhaus 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.
PubMed 21082307Patcas 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.
PubMed 25836346Youssef 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.
PubMed 32901234
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Efficacy of Resin Infiltration Using Different Conditioning Methods: 24-Month Results
- ClinicalTrials.gov ID
- NCT06259214
- Acronym / sponsor ID
- 1700213
- Conditions
- White Spot Lesion
- Keywords
- Color stability, Fluorescence, Resin infiltration, White spot lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 6 Jan 2019 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Prior to the study an experienced investigator (EK) attended a training and calibration session (k value = 0.88) and evaluated the severity of WSLs under direct illumination using a dental lamp with the aid of a standard 3.0× loupe (Keeler, Windsor, UK). Isolation was achieved with a cotton roll and suction. For the visual severity evaluation, all teeth were cleaned and air dried for 5 s and each lesion was scored according to ICDAS II free smooth-surface criteria [20]. Lesions with code 1 (first visual change after prolonged air drying) and code 2 (distinct visual changes without air drying) were included. The teeth were cleaned with a rubber cup and pumice, rinsed, and air dried (each for 30 s).
The same investigator (EK) used a DIAGNOdent Pen 2190 (Kavo, Biberach, Germany) to score each lesion afterwards. 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.
Out of 40 consecutive patients between 14 and 21 years of age who had just finished their fixed orthodontic treatment, 4 patients declined to participate in the trial and 6 patients did not meet the inclusion criteria, and 30 patients (18 females, 12 males, aged 15-19 years, mean age 17.1 years) with at least four WSLs on the buccal surfaces after bracket debonding were included in the trial. Patients with any systemic disease, bad oral hygiene, a smoking habit, enamel hypoplasia, staining, fluorosis, or restoration or cavity in any teeth with WSLs were excluded from the study. At the end of the clinical examination a total of 120 non-cavitated, unrestored WSLs after multibracket treatment on the buccal surfaces of the anterior and premolar teeth in the upper and lower jaws of 30 patients were included.
A spectrophotometer (SpectroShade; Medical High Technologies, Italy) was used to measure color parameters in the same examination room with standardized light conditions. 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.
Treatment
After rubber dam placement, the lesions of each patient were randomly divided into 4 groups (n = 30):
G1 (control): The control group received no treatment except regular brushing, G2: 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).
G3: 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).
G4: An 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%.
The lesions were desiccated with ethanol (Icon Dry, DMG, Hamburg, Germany) and air dried for 30 s. Then resin infiltrant (Icon Infiltrant, DMG, Hamburg, Germany) was applied to the tooth surface and allowed to penetrate for 3 min. A cotton roll was used to wipe excess material from the surface, and the material then was light cured for 40 s with an LED device (EliparTM S10; 3M ESPE, St. Paul, MN, USA) with 1200 mW/cm2 light intensity in standard continuous mode. The clinician repeated the infiltration step for 1 min to infiltrate any remaining porosities. Dental floss was used to remove any excess resin from the proximal areas. Then polishing was conducted with Sof-Lex disks (3M ESPE, St. Paul, MN, USA) using a slow-speed handpiece. The disks were used in a decreasing sequence of granulation and each disk was used for 5 s. The same clinician (KAU) conducted all restorative procedures.
All patients were given oral hygiene instructions and oral hygiene packages, which included a toothbrush (Oral B, Advantage Sensitive, P\&G Oral Health Care, Mason, OH, USA), fluoride toothpaste (Pro-Expert Professional Protection, Ipana, Gross-Gerau, Germany), and dental floss (Oral B, Essential floss, P\&G Oral Health Care, Mason, OH, USA). The patients were asked not to use any other dental products during the study period and the oral hygiene packages were renewed every 2 months.
Follow up examination All patients attended the follow-up visits. New caries formation was evaluated during the follow-ups. In the treatment groups the DIAGNOdent Pen and spectrophotometer examinations were performed at baseline (T0), just after the resin infiltration treatment (T1), and after 6 (T2) and 24 months (T3). In the control group, the DIAGNOdent Pen and spectrophotometer examinations were performed at baseline (T0) and after 6 (T2) and 24 months (T3). Fluorescence and color values were recorded as previously described by the same investigator (EK), who was blinded regarding the treatment group allocation of the teeth.
The differences in fluorescence and color values were evaluated by taking into account the differences between the initial values and the values at the different evaluation times. L*, a*, and b* were measured each time, and the changes in them (ΔL, Δa, and Δb) were calculated. The L*-axis indicates how light a sample is (0 is black and 100 is white). The red/green axis is represented by the a*-value, with an increase meaning a higher red color component. The yellow/blue axis is represented by the b*-value, with an increase meaning higher yellow color. The color change ΔE<3.7 is considered a clinically acceptable color difference [9] and ΔE for each tooth was calculated as follows:
ΔE= [(ΔL)2+ (Δa)2+ (Δb)2]1/2 Statistical analysis The normality of the variables was evaluated with the Kolmogorov-Smirnov test and the homogeneity of the variances was evaluated with the Levene test. Variables were summarized as median [25th-75th percentile] values. In the variables that met the parametric test assumptions, the differences between groups and within groups were tested with analysis of variance in repeated measurements. The Bonferroni test was used for pairwise comparisons. In the variables that did not meet the parametric test assumptions, the differences between the groups were determined with the Friedman test and the differences between the groups were determined with the Kruskal-Wallis test. In the event of a difference, pairwise comparisons were conducted with Dunn's test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| regular brushing | No intervention | –regular brushing |
| 15% HCl gel | Active comparator | Other: 15% HCl gel15% 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) |
| 37% H3PO4 gel | Active comparator | Other: H3PO4 gel37% 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) |
| Er:YAG laser | Active comparator | Other: Er:YAG laserEr: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%. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- at least four white spot lesions on the buccal surfaces after bracket debonding
Key exclusion criteria (1 listed)
- any systemic disease bad oral hygiene smoking habit enamel hypoplasia staining fluorosis restoration or cavity in any teeth with white spot lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15% HCl gelIcon , DMG, Hamburg, Germany | Other | 15% HCl gel |
| H3PO4 gelScotchbond Etchant, 3M ESPE, St. Paul, MN, USA | Other | 37% H3PO4 gel |
| Er:YAG laserFotona AT Fidelis III, Ljubljana, Slovenia | Other | Er:YAG laser |
Primary outcome
color change
Time frame: 24 month
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.
fluorescence loss
Time frame: 24 monrth
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 21536209Richter AE, Arruda AO, Peters MC, Sohn W. Incidence of caries lesions among patients treated with comprehensive orthodontics. Am J Orthod Dentofacial Orthop. 2011 May;139(5):657-64. doi: 10.1016/j.ajodo.2009.06.037.
- Background: PubMed 21208070Tufekci 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.
- Background: PubMed 2816842Ogaard 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.
- Background: PubMed 21966335Bergstrand 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.
- Background: PubMed 32742092Dogra 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.
- Background: PubMed 30992105Faghihian 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.
- Background: PubMed 21082307Neuhaus 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.
- Background: PubMed 25836346Patcas 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.
- Background: PubMed 32901234Youssef 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15% HCl gel, H3PO4 gel and Er:YAG laser in people with White Spot Lesion, run by Ondokuz Mayıs University 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 1 inclusion and 1 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 14 Feb 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 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?
color change (time frame: 24 month). 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 NCT06259214, which also lists 9 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 Feb 2024.