Phase 4
Completed N=62
MI Varnish for the Prevention of White Spot Lesions
White Spot Lesion · Orthodontic Treatment
Source: ClinicalTrials.gov NCT03446690 ↗
Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcomePrimary: Enamel Decalcification Index (EDI) Scores — 1.038; 1; 1.308; 2.724 scores on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The current study aimed to determine if MI Varnish has an effect in preventing the formation of white spot lesions for patients undergoing orthodontic treatment. 33 subjects were prospectively recruited for the project as the MI Varnish group, with a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes.Difference in prevention of white spot formation between the control and the study groups were evaluated through photographic records and clinical examination by using the Enamel Decalcification Index (EDI) scores.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enamel Decalcification Index (EDI) Scores |
1.038; 1; 1.308; 2.724; 1.923; 3.966 | — |
Eligibility Criteria
Inclusion Criteria
- Patients seeking orthodontic treatment and receiving routine treatment and oral hygiene regimes.
Exclusion Criteria
- Any medical or dental condition that in the opinion of the investigator could impact study results during the expected length of the study;
- Patient is currently using any investigational drug or any other investigational device;
- Patient plans to relocate or move within six months of enrollment.
Data sourced from ClinicalTrials.gov (NCT03446690). 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. Informational only — not medical advice.