Clinical trial NCT01733888: Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis Stains
Official title: Evaluating the Effect of Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Non Pitted Fluorosis Stains in Indian Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries Infiltration
Fluorosis
Dental Care
Keywords: caries
caries infiltration
fluorosis treatment
Lead sponsor: DMG Dental Material Gesellschaft mbH
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Esthetic Changes
timeFrame: Immediate
Secondary outcomes:
measure: Improvement in Brown Stains/ Change in White Opacities
timeFrame: Immediate
Other outcomes:
Locations:
city: Yamuna Nagar
country: India
facility: Department of Pediatric and Preventive Dentistry DAV Dental College
state: Haryana
city: Faridkot
country: India
facility: Department of Pediatric and Preventive Dentistry DRIDS Dental College
state: Punjab
Study officials:
affiliation: Department of Pediatric and Preventive Dentistry DAV Dental College Yamuna Nagar 135001 Haryana India
name: Neeraj Gugunani, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gugnani N, Pandit IK, Gupta M, Gugnani S, Soni S, Goyal V. Comparative evaluation of esthetic changes in nonpitted fluorosis stains when treated with resin infiltration, in-office bleaching, and combination therapies. J Esthet Restor Dent. 2017 Sep;29(5):317-324. doi: 10.1111/jerd.12312. Epub 2017 Jun 27.