White spot lesion (WSL) is the first clinical sign of enamel caries that presents itself
as a milky-white opacity non-cavitated when located on smooth surfaces. These surfaces
are rougher than sound enamel, and they can be arrested or progressed. WSLs are more
commonly seen on the outer surface of teeth after orthodontics treatment. Causing
unaesthetic appearance on the anterior teeth and increasing chance of dental caries
progression.
Different interventions have been introduced to manage WSL as preventing demineralization
and biofilm formation, and promoting remineralization with fluoride varnish, casein
phosphopeptides-amorphous calcium phosphate (CPP-ACP)- a nano-complex derived from milk
casein that significantly increases salivary calcium and phosphate levels9 .
The remineralization of enamel subsurface lesions by CPP-ACP has been demonstrated in
several in vitro studies. The potential of CPP-ACP to prevent enamel demineralization and
promote lesion remineralization has also been successfully demonstrated in human in situ
models. In the presence of fluoride, CPP-ACP has been shown to promote the formation of
fluorapatite-like minerals deep in the subsurface lesion. Clinical studies evaluating the
effect of CPP-ACP/ACFP on WSLs after debonding report significant regression of WSL
numbers, size, and activity in comparison to fluoride or substances without fluoride.
Consequently, CPP-ACP has been incorporated into minimally invasive products for the
remineralization of WSLs. Nevertheless, other studies state significant change showing
improvements in WSLs with remineralization products but no superiority of CPP-ACP .
Multiple studies have tested the efficacy of CPP-ACP on post-orthodontic WSLs but only a
limited number of prospective clinical studies have examined the effect of CPP-ACP and
fluoride + etch on WSLs developed during orthodontic treatment. It is during therapy with
fixed appliances that patients are most susceptible to forming WSLs and WSLs are most
active. Recently, treatment with resin infiltration has been developed by the dentistry
equipe at Charité University of Berlin, Germany and was first proposed to halt the
interproximal early stage non-cavitated caries lesions. It represents a new concept in
dentistry that offers valuable clinical applicability for clinicians and high acceptance
by patients and is an alternative method to treat early caries lesions that are not
expected to remineralize or arrest by non-invasive measures when the infiltration is
performed with low-viscosity light-curing resins.
The refractive index (RI) of enamel lesions is effective in arresting and stabilizing the
progress of WSLs. Paris et al noted that lesions infiltrated by resin infiltration took
on the appearance of the surrounding sound enamel masking the whitish appearance by
filling the lesion's body with resin, which results in a rise of the refractive index
(RI) of the lesion from 1-1. to 1.42-1.44 with resin infiltration, which is closer to a
healthy enamel (1.62-1.63). Thus, a restoration with enamel-like optical characteristics
is obtained. This technique is considered micro-invasive and may bridge the gap between
the non-invasive and minimally invasive treatment of WSLs, postponing the need for a
restoration as long as possible.
According to few in-vivo studies investigating the effectiveness of remineralization
products to address the appearance of WSLs after orthodontic treatment.
The aim of the current study is to assess clinically the change in the WSL appearance of
the maxillary incisors in patients treated with resin-infiltration + etch compared with
patients treated with CPP-ACFP plus +etch .
Hypothesis: No significant difference will be expected between CPP-ACFP +etch (MI paste
plus + etch) and resin infiltration etch in terms of improving the WSL however, the
esthetic outcome of resin infiltration + etch will be significantly greater compared to
MI paste plus + etch.
Justification: Few studies have evaluated in vivo the WSL change satisfaction of resin
infiltration compared to CPP-ACP and fluoride + etch after orthodontic treatment for more
than a year for follow ups. In-vitro and in-vivo studies have shown a change in WSLs as a
result of the topical use of these materials. However, further studies are needed to
prove their role in calcium-based remineralization systems.
Objectives:
Determine the effect of resin infiltration and CPP-ACP in the caries process Determine
the effect of resin infiltration and CPP-ACP in incisors aesthetics
Methods:
In this clinical randomized controlled trial study, sixty two subjects in the age range
of 12-21 years having at least one post-orthodontic WSL on the upper or lower incisors
will be randomly assigned to two groups of 31 samples in each. Participants will be
recruited from patients who underwent labial fixed orthodontic treatment with (bracket
properties), bonded with light-cured composite resin adhesive (Transbond XT, 3M Unitek,
U.S.A) in the Department of Orthodontics, Dental School, University of Alberta. The study
period will be from March 2023 and so on with prior approval from IRB (HERB). Informed
consents will be obtained from parents/caregivers of the children after explaining the
details of the treatment procedure in a designated format in regional and English
languages.
Justification of the sample size :
Using results from Baffif et al. (2020), sample size is estimated based on the effect
size demonstrated from ICON as compared at the 6 month level is a mean difference of 0.8
with a standard deviation of 1.3. Assuming power of 0.8 and alpha of 0.05, the required
sample size is 31 per group.The selected samples will be randomly allocated to two groups
according to treatment received.
Group I- Resin infiltration -Icon + etch, DMG, Germany, (n=31). Group II- MI paste plus
+etch , GC corporation, Germany, Europe, (n=31). Before the application of topical agents
on white spot lesions, oral prophylaxis will be carried out and the affected tooth to be
treated will be cleaned with a rubber cup with prophylaxis paste (3M, Clinpro, United
States of America) in both groups.
Information in regards to the length of orthodontic treatment, date of removal of
orthodontic appliances, and oral hygiene status during treatment will be collected from
the patients' charts. Patients will randomly receive an 8-week regimen of MI paste plus
or resin infiltration. Patients will be followed up at 3,6, 12 and 18 months to evaluate
change in appearance of the lesion of both treatments.
Plan for Data Analysis:
Remineralization will be assessed by the enamel decalcification index score (EDI) and
International caries detection and assessment system (ICDAS) to evaluate the WSLs change
after treatment with the two remineralizing agents. Furthermore, the satisfaction
evaluation of the lesion will be assessed by a Visual Analog Scale (VAS) from 0 mm no
change to 100 mm WSL completely changed/disappeared. The assessment will be done with
photographs. Intraoral frontal views will be taken digitally. These photographs will be
obtained at baseline (a few days after debonding to allow resolution of gingival
inflammation that might mask WSLs), 3, 6,12 and 18 months after completion of orthodontic
treatment. The patients will be asked to tilt up their head approximately 5-10 degrees to
limit the flash reflection to the incisal third of the maxillary incisors. The optimal
image will be selected among several photographs that will be taken at each time point.
The first panel will consist of 3 dental experts (orthodontists and pediatric dentists)
while the second panel will consist of three laypersons. Each examiner will perform the
assessment independently.
Statistical analysis:
The collected data will be subjected to statistical analysis using SPSS version 22.0
(Armonk, NY, IBM Corp). Demographic variables will be analyzed using proportions.
Independent sample 't' test will be used to compare the mean difference in esthetic
appearance (VAS) and lesion.
Repeated Measures ANOVA will be used to determine the mean difference in VAS and EDI
score, within study groups at various time intervals.
Expected results No significant difference will be expected between MI paste plus+etch
and resin infiltration etch in terms of improving the WSL; however, the esthetic outcome
of resin infiltration + etch will be significantly greater compared to MI paste plus +
etch.
Study significance WSLs are prevalent lesions on the surface of teeth particularly,
around the attached brackets, which lead to unaesthetic appearance of teeth after bracket
removal and increase the chance of initiation of dental caries. Caries in the anterior
teeth compromise the aesthetic enhancement achieved by orthodontic treatment. Thus,
introducing a material that changes the WSL while providing the most similar appearance
to the tooth enamel will be of great value.
Risks and Discomforts This technique has no risk or discomfort during the research, as
both materials have been approved in Canada. Except that the application of CCP-ACP +
fluoride may be difficult for some people as they need to use it at home. This material
is contraindicated in patients with a proven or suspected milk protein allergy and/or
with a sensitivity or allergy to benzoate preservatives. No side effects have been
reported so far.
During the study visits, there may be an increased risk of COVID-19 exposure due to the
added time spent within our health care facility and possible exposure to others. All AHS
Infection Prevention and Control Practices in place during the pandemic (screening for
COVID 19 symptoms prior to hospital entry, use of masks, hand sanitizer and physical
distancing measure where possible) will also apply during these visits to reduce COVID-
19 risks.
There may be risks in this study that are currently not known. If the investigators find
out anything new during the course of this research which may change participants'
willingness to be in the study, the investigators will tell participants about these
findings.