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Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis Stains

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01733888
First Posted: November 27, 2012
Last Update Posted: June 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Department of Pedodontics & PCD, DAV (C) Dental College Yamuna Nagar, Haryana, INDIA
Dashmesh Institute of Dental Scinces, Faridkot, Punjab, INDIA
Information provided by (Responsible Party):
DMG Dental Material Gesellschaft mbH
  Purpose

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 White spot lesions (WSLs) per say and post orthodontics WSLs in different both 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 damaged teeth by fluorosis.


Condition Intervention
Caries Infiltration Fluorosis Dental Care Device: Office Bleaching with 35 % Hydrogen Peroxide Device: Icon Infiltration Device: Icon Infiltration twice Device: Bleaching+Icon Infiltration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by DMG Dental Material Gesellschaft mbH:

Primary Outcome Measures:
  • pre-treatment and post-treatment colour changing (L*A*B values) of digital photographs of fluorosed teeth of all the four groups [ Time Frame: 6 month ]

Secondary Outcome Measures:
  • pre-treatment esthetic perception by the subjects of their fluorosed teeth [ Time Frame: 6 month ]
  • post-treatment patient satisfaction using the Patient satisfaction scale [ Time Frame: 1 week ]

Estimated Enrollment: 80
Study Start Date: July 2013
Study Completion Date: May 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Office Bleaching Device: Office Bleaching with 35 % Hydrogen Peroxide
In this group before starting the procedure the teeth intended to be treated will be cleaned with pumice and after that cheek retractors will be placed and exposed lip surface will be covered with petroleum gel. Thereafter, teeth will be dried and gingival Barrier will be applied to both arches, slightly overlapping enamel and interproximal spaces. Light curing of the gingival barrier will be done in a fanning motion for 10-20 seconds . Once the gingival barrier will be cured then homogeneous mixing of the powder and liquid will be done in powder pot, followed by application of thick layer of gel to all teeth undergoing treatment. The gel will be then left in place for 8 minutes and after that the gel will be removed using a surgical aspirator tip.
Other Name: Pola Office, SDI, Australia
Experimental: Resin Infiltration Device: Icon Infiltration
In this group after taking pre-operative photographs the fluorosed tooth will be isolated using rubber dam and the Resin infiltrant (Icon, DMG, Hamburg, Germany) will be applied as per manufactures' instructions. For this purpose, after rubber dam application tooth surface will be dried using cotton rolls and air syringe. Icon Etchant will be applied and left for 2 minutes followed by rinsing and air drying for 30 sec. After complete etching, Drying agent (99% ethanol), as supplied in the Icon kit. Resin infiltrant will then be applied and allowed to seep in for 3 minutes followed by light curing for 40 seconds followed by cleaning of the surface with pumice and rubber polishing cup and rinsing with water for 30 sec. After application, patient will be instructed neither to eat nor brush their teeth for 45 minutes.
Other Name: Icon, Kit for caries infiltration, DMG, Hamburg, Germany
Experimental: Resin Infiltration twice Device: Icon Infiltration twice
In this group application of the resin infiltration shall be done similar to the procedure as explained for intervention "Icon infiltration", but the resin infiltrant shall be applied twice.
Other Name: Icon Kit for caries infiltration, DMG, HAmburg, Germany
Experimental: Office Bleaching + Resin Infiltration Device: Bleaching+Icon Infiltration
In this group vital bleaching will be done using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia), as explained in intervention "bleaching"; followed by wash over period of 20 days. After 20 days the patient will be recalled and on the day of appointment initially a new preoperative photograph shall be taken, then the fluorosed tooth will be isolated using rubber dam and the Resin infiltrant (Icon, DMG, Hamburg, Germany) will be applied as per manufactures' instructions, similar to intervention "Icon Infiltration". For this group a postoperative photograph shall be taken after the application of RI and then the circle of post-operative recall shall be counted from here, that is, 1week, 1 month and 6 months respectively.
Other Names:
  • Icon Kit for Caries Infiltration, DMG, Hamburg, Germany
  • 35 % Hydrogen Peroxide, Pola Office, SDI, Australia

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733888


Locations
India
Department of Pediatric and Preventive Dentistry DAV Dental College
Yamuna Nagar, Haryana, India, 135001
Department of Pediatric and Preventive Dentistry DRIDS Dental College
Faridkot, Punjab, India
Sponsors and Collaborators
DMG Dental Material Gesellschaft mbH
Department of Pedodontics & PCD, DAV (C) Dental College Yamuna Nagar, Haryana, INDIA
Dashmesh Institute of Dental Scinces, Faridkot, Punjab, INDIA
Investigators
Principal Investigator: Neeraj Gugunani, Prof. Dr. Department of Pediatric and Preventive Dentistry DAV Dental College Yamuna Nagar 135001 Haryana India
  More Information

Responsible Party: DMG Dental Material Gesellschaft mbH
ClinicalTrials.gov Identifier: NCT01733888     History of Changes
Other Study ID Numbers: FLUORIC
First Submitted: November 14, 2012
First Posted: November 27, 2012
Last Update Posted: June 23, 2014
Last Verified: June 2014

Keywords provided by DMG Dental Material Gesellschaft mbH:
caries
caries infiltration
fluorosis treatment

Additional relevant MeSH terms:
Fluoride Poisoning
Fluorosis, Dental
Poisoning
Chemically-Induced Disorders
Tooth Diseases
Stomatognathic Diseases
Hydrogen Peroxide
Immunoconjugates
Anti-Infective Agents, Local
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs


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