Caries InfiltrationNCT01733888
Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis Stains
A study testing Office Bleaching, Resin Infiltration and Resin Infiltration twice in people with Caries Infiltration and Fluorosis, run by DMG Dental Material Gesellschaft mbH at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Caries Infiltration, Fluorosis, Dental Care
- What is being tested?
- Office Bleaching, Resin Infiltration and Resin Infiltration twice
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesIndia
- Study dates
- Jul 2013to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Department of Pediatric and Preventive Dentistry DRIDS Dental College
Farīdkot, Punjab
Department of Pediatric and Preventive Dentistry DAV Dental College
Yamuna Nagar, Haryana, 135001
About this study
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
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.
- Conditions
- Caries Infiltration, Fluorosis, Dental Care
- Being tested
- Office Bleaching, Resin Infiltration, Resin Infiltration twice, Bleaching + Resin Infiltration
- Keywords
- caries, caries infiltration, fluorosis treatment
- Medical subject headings
- Fluoride Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office BleachingDevice
Also called 35 % Hydrogen Peroxide, Pola Office, SDI, Australia
Teeth will be cleaned with pumice first, followed by placing cheek retractors and covering of the lip surface 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. This is followed by homogeneous mixing of the powder and liquid in a powder pot the application of a thick layer of the resulting gel to all teeth undergoing treatment (35 % Hydrogen Peroxide, Pola Office, SDI, Australia). The gel will be left in place for 8 minutes and subsequently removed using a surgical aspirator tip.
Resin InfiltrationDevice
Also called Icon, Kit for caries infiltration, DMG, Hamburg, Germany
Fluorosed teeth will be isolated using a rubber dam and the resin infiltrant (Icon, DMG, Hamburg, Germany) will be applied as per manufactures' instructions. In short, tooth surface will be dried using cotton rolls and air syringe. This is followed by an etching (Icon Etch) and drying step (Icon-Dry) to open the lesion surface. Resin infiltrant will then be applied and allowed to seep in for 3 minutes followed by light curing for 40 seconds and subsequent cleaning of the surface with pumice and rubber polishing cup as well as rinsing with water for 30 sec.
Resin Infiltration twiceDevice
Also called Icon Kit for caries infiltration, DMG, Hamburg, Germany
The intervention will be done similar to the "Resin infiltration" arm, which the exception that the icon infiltration step will be done twice.
Bleaching + Resin InfiltrationDevice
Also called Icon Kit for Caries Infiltration, DMG, Hamburg, Germany, 35 % Hydrogen Peroxide, Pola Office, SDI, Australia
In this arm, the fluorosed teeth of the patients will first be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia) as explained in the intervention arm "Office bleaching"; followed by wash over period of 20 days. After these 20 days, patients will be recalled and the fluorosed teeth will treated according to the description in the "Resin infiltrant" intervention arm using the resin infiltrant (Icon, DMG, Hamburg, Germany) as per manufactures' instructions.
| Study group | Role | What they receive |
|---|---|---|
| Office Bleaching | Active comparator | Fluorosed teeth will be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. Receives: Device: Office Bleaching |
| Resin Infiltration | Experimental | White spots in fluorosed teeth will be infiltrated using the resin infiltrant "Icon" (DMG, Hamburg, Germany) according to manufactures´ instructions. Receives: Device: Resin Infiltration |
| Resin Infiltration twice | Experimental | White spots in fluorosed teeth will be infiltrated using the resin infiltrant Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. Here, the infiltrant "Icon" is applied twice. Receives: Device: Resin Infiltration twice |
| Office Bleaching + Resin Infiltration | Experimental | Fluorosed teeth will be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia). After a 20 day wash over period, these teeth will be treated with the resin infiltration intervention (Icon, DMG, Hamburg, Germany). Receives: Device: Bleaching + Resin Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esthetic Changes
Pre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with "1 = no improvement" and "7 = exceptional improvement".
Measured: Immediate
Secondary outcomes (1)
Improvement in Brown Stains/ Change in White Opacities
Pre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with "1 = no improvement" and "7 = exceptional improvement".
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caries InfiltrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- DMG Dental Material Gesellschaft mbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neeraj Gugunani, Prof. Dr., Principal investigator, Department of Pediatric and Preventive Dentistry DAV Dental College Yamuna Nagar 135001 Haryana India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733888
- Sponsor's protocol ID
- FLUORIC
- Status last verified
- May 2022
- First submitted
- 14 Nov 2012
- Last updated
- 25 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28654721
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01733888
- Acronym / sponsor ID
- FLUORIC
- Conditions
- Caries Infiltration, Fluorosis, Dental Care
- Keywords
- caries, caries infiltration, fluorosis treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- DMG Dental Material Gesellschaft mbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Posted 25 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Office Bleaching | Active comparator | Device: Office BleachingFluorosed teeth will be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. |
| Resin Infiltration | Experimental | Device: Resin InfiltrationWhite spots in fluorosed teeth will be infiltrated using the resin infiltrant "Icon" (DMG, Hamburg, Germany) according to manufactures´ instructions. |
| Resin Infiltration twice | Experimental | Device: Resin Infiltration twiceWhite spots in fluorosed teeth will be infiltrated using the resin infiltrant Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. Here, the infiltrant "Icon" is applied twice. |
| Office Bleaching + Resin Infiltration | Experimental | Device: Bleaching + Resin InfiltrationFluorosed teeth will be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia). After a 20 day wash over period, these teeth will be treated with the resin infiltration intervention (Icon, DMG, Hamburg, Germany). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Office BleachingAlso: 35 % Hydrogen Peroxide, Pola Office, SDI, AustraliaTeeth will be cleaned with pumice first, followed by placing cheek retractors and covering of the lip surface 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. This is followed by homogeneous mixing of the powder and liquid in a powder pot the application of a thick layer of the resulting gel to all teeth undergoing treatment (35 % Hydrogen Peroxide, Pola Office, SDI, Australia). The gel will be left in place for 8 minutes and subsequently removed using a surgical aspirator tip. | Device | Office Bleaching |
| Resin InfiltrationAlso: Icon, Kit for caries infiltration, DMG, Hamburg, GermanyFluorosed teeth will be isolated using a rubber dam and the resin infiltrant (Icon, DMG, Hamburg, Germany) will be applied as per manufactures' instructions. In short, tooth surface will be dried using cotton rolls and air syringe. This is followed by an etching (Icon Etch) and drying step (Icon-Dry) to open the lesion surface. Resin infiltrant will then be applied and allowed to seep in for 3 minutes followed by light curing for 40 seconds and subsequent cleaning of the surface with pumice and rubber polishing cup as well as rinsing with water for 30 sec. | Device | Resin Infiltration |
| Resin Infiltration twiceAlso: Icon Kit for caries infiltration, DMG, Hamburg, GermanyThe intervention will be done similar to the "Resin infiltration" arm, which the exception that the icon infiltration step will be done twice. | Device | Resin Infiltration twice |
| Bleaching + Resin InfiltrationAlso: Icon Kit for Caries Infiltration, DMG, Hamburg, Germany, 35 % Hydrogen Peroxide, Pola Office, SDI, AustraliaIn this arm, the fluorosed teeth of the patients will first be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia) as explained in the intervention arm "Office bleaching"; followed by wash over period of 20 days. After these 20 days, patients will be recalled and the fluorosed teeth will treated according to the description in the "Resin infiltrant" intervention arm using the resin infiltrant (Icon, DMG, Hamburg, Germany) as per manufactures' instructions. | Device | Office Bleaching + Resin Infiltration |
Primary outcome
Esthetic Changes
Time frame: Immediate
Pre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with "1 = no improvement" and "7 = exceptional improvement".
1 secondary outcome
Improvement in Brown Stains/ Change in White Opacities
Time frame: Immediate
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28654721Gugnani 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.
- Individual participant dataSharing planned: No
Related trials for Caries Infiltration
Recruiting
Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment
White Spot Lesions, Orthodontic Appliance Complication
Recruiting
Intraosseous vs Infiltration Anesthesia in Molar-Incisor Hypomineralization (MIH) Children
Molar Incisor Hypomineralization, Hypersensitivity
Recruiting
Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients
Dental Caries, Reversible Pulpitis
Active, not recruitingPhase 4
Assessing the Effects of Resin Infiltration and Resin Modified Glass Ionomer on the Color Changes of White Spot Lesions in a Clinical and Laboratory Setting
White Spot Lesions, White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neeraj Gugunani, Prof. Dr. principal investigator
Department of Pediatric and Preventive Dentistry DAV Dental College Yamuna Nagar 135001 Haryana India
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Office Bleaching, Resin Infiltration and Resin Infiltration twice in people with Caries Infiltration and Fluorosis, run by DMG Dental Material Gesellschaft mbH at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esthetic Changes (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01733888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.