N/A
N=80
Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis Stains
Caries Infiltration · Fluorosis · Dental Care
Bottom Line
View on ClinicalTrials.gov: NCT01733888 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Esthetic Changes — 1.90; 5.50; 5.53; 5.35 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Office Bleaching (Device); Resin Infiltration (Device); Resin Infiltration twice (Device); Bleaching + Resin Infiltration (Device)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- DMG Dental Material Gesellschaft mbH
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Esthetic Changes |
1.90; 5.50; 5.53; 5.35 | — |
| SECONDARY Improvement in Brown Stains/ Change in White Opacities |
1.53; 4.98; 5.18; 4.40 | — |
Summary
Dental fluorosis is a clinical manifestation of chronic exposure to high intakes of fluoride during the tooth development.
The present study is planned to evaluate the efficacy of Resin Infiltration technique in improving the esthetics of non-pitted fluorosis stains on permanent anterior teeth. Resin infiltration is a novel method that has shown its efficacy in improving the esthetics of various types of white spot lesions (WSLs), particularly post orthodontics WSLs, in in-situ and in-vivo studies. The Resin Infiltration technique is also known to stop the progression of caries in non cavitated lesions in both, smooth surface and interproximal lesions.
Therefore, the following trial will be conducted to assess the esthetic improvement of fluorosed permanent anterior teeth after resin infiltration and compare it with standard bleaching procedure and a combination of bleaching and Resin infiltration therapy in children with fluorosed teeth.
Eligibility Criteria
Inclusion Criteria
- Only the non-pitted Fluorosis opacities shall be included for this purpose; opacities in anterior teeth shall be classified according to Russell's criteria for differentiating fluoride and non- fluoride opacities
- Subjects classified /Teeth classified with dental fluorosis of 1-4 according to Thylstrup, Fejerskov classification of dental fluorosis 20
- Patients who will be willing to participate in the study and who will be accepting for recall visit.
Exclusion Criteria
- History of allergy towards any dental material.
- Teeth classified as non-fluoride opacities
- Subjects with any systemic and local conditions not permitting the treatment
- Subjects who had undergone any treatment for dental fluorosis earlier
- Subjects with direct or indirect restorations in maxillary central or lateral incisors.
- Subjects not willing to participate in the study
- Subjects with fractured teeth maxillary central or lateral incisors.
Data sourced from ClinicalTrials.gov (NCT01733888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.