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Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part I: photographic data evaluation
White spot lesions (WSLs) are a frequent side-effect of multibracket appliance treatment. The effect of local fluoridation on post-orthodontic WSL is however inconclusive. Assessment of WSL changes in response to weekly 1.25 per cent fluoride gel application after multibracket appliance treatment. R...
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| Published in: | European journal of orthodontics 2017-04, Vol.39 (2), p.134-143 |
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| container_end_page | 143 |
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| container_start_page | 134 |
| container_title | European journal of orthodontics |
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| creator | Bock, Niko C Seibold, Laura Heumann, Christian Gnandt, Erhard Röder, Miriam Ruf, Sabine |
| description | White spot lesions (WSLs) are a frequent side-effect of multibracket appliance treatment. The effect of local fluoridation on post-orthodontic WSL is however inconclusive.
Assessment of WSL changes in response to weekly 1.25 per cent fluoride gel application after multibracket appliance treatment.
Randomized, single-centre, double-blind, parallel-group, placebo-controlled study.
Patients with not less than 1 WSL (modified score 1 or 2) on not less than 1 upper front teeth after debonding.
Professional fluoride/placebo gel application during weeks 1-2; self-administered home application (weeks 3-24).
Photographic WSL assessment (dimension and luminance) of the upper front teeth (T0-T5).
Random assignment to test (n = 23) or placebo group (n = 23) using a sequentially numbered list (random allocation sequence generated for 50 subjects in 25 blocks of 2 subjects each).
The clinical study duration lasted from March 2011 to September 2013.
Unblinding was performed after complete data evaluation.
Intent-to-treat analysis set comprising 39 participants (test: n = 21, placebo: n = 18).
Dimensional WSL quantification showed limited reliability. Luminance improvement (%) of WSL, however, was seen after 6 months (test/placebo: tooth 12, 24.8/18.0; tooth 11, 38.4/35.4; tooth 21, 39.6/38.3; and tooth 22, 15.2/25.0). No statistically significant group difference existed. Data suggest that WSLs are difficult to measure with respect to reliability and repeatability and methods for monitoring WSLs in clinical trials require improvement/validation.
Similar adverse events occurred in both groups; none was classified as possibly related to the study product.
The number of dropouts was higher than expected and the socio-economic status was not assessed. Furthermore, the unknown level of compliance during the home application phase must be considered as limitation.
Based on the results of this study, no difference could be detected with respect to the development of WSL under post-orthodontic high-dose fluoride treatment.
The study was registered with ClinicalTrials.gov (Identifier: NCT01329731).
The protocol wasn't published before trial commencement. |
| doi_str_mv | 10.1093/ejo/cjw060 |
| format | article |
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Assessment of WSL changes in response to weekly 1.25 per cent fluoride gel application after multibracket appliance treatment.
Randomized, single-centre, double-blind, parallel-group, placebo-controlled study.
Patients with not less than 1 WSL (modified score 1 or 2) on not less than 1 upper front teeth after debonding.
Professional fluoride/placebo gel application during weeks 1-2; self-administered home application (weeks 3-24).
Photographic WSL assessment (dimension and luminance) of the upper front teeth (T0-T5).
Random assignment to test (n = 23) or placebo group (n = 23) using a sequentially numbered list (random allocation sequence generated for 50 subjects in 25 blocks of 2 subjects each).
The clinical study duration lasted from March 2011 to September 2013.
Unblinding was performed after complete data evaluation.
Intent-to-treat analysis set comprising 39 participants (test: n = 21, placebo: n = 18).
Dimensional WSL quantification showed limited reliability. Luminance improvement (%) of WSL, however, was seen after 6 months (test/placebo: tooth 12, 24.8/18.0; tooth 11, 38.4/35.4; tooth 21, 39.6/38.3; and tooth 22, 15.2/25.0). No statistically significant group difference existed. Data suggest that WSLs are difficult to measure with respect to reliability and repeatability and methods for monitoring WSLs in clinical trials require improvement/validation.
Similar adverse events occurred in both groups; none was classified as possibly related to the study product.
The number of dropouts was higher than expected and the socio-economic status was not assessed. Furthermore, the unknown level of compliance during the home application phase must be considered as limitation.
Based on the results of this study, no difference could be detected with respect to the development of WSL under post-orthodontic high-dose fluoride treatment.
The study was registered with ClinicalTrials.gov (Identifier: NCT01329731).
The protocol wasn't published before trial commencement.</description><identifier>ISSN: 0141-5387</identifier><identifier>EISSN: 1460-2210</identifier><identifier>DOI: 10.1093/ejo/cjw060</identifier><identifier>PMID: 27702806</identifier><language>eng</language><publisher>England</publisher><subject>Adolescent ; Bicuspid - pathology ; Cariostatic Agents - administration & dosage ; Cariostatic Agents - therapeutic use ; Child ; Cuspid - pathology ; Dental Caries - drug therapy ; Dental Caries - etiology ; Dentistry ; Double-Blind Method ; Drug Administration Schedule ; Female ; Fluorides, Topical - administration & dosage ; Fluorides, Topical - therapeutic use ; Humans ; Male ; Orthodontic Brackets - adverse effects ; Photography, Dental - methods ; Reproducibility of Results ; Tooth Remineralization - methods</subject><ispartof>European journal of orthodontics, 2017-04, Vol.39 (2), p.134-143</ispartof><rights>The Author 2016. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c323t-3786fc1898f7fbcedf949ac75f4652371c1f8fb5fe6ee1a8d8e4542a8fdf920b3</citedby><cites>FETCH-LOGICAL-c323t-3786fc1898f7fbcedf949ac75f4652371c1f8fb5fe6ee1a8d8e4542a8fdf920b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790,27957,27958</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27702806$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bock, Niko C</creatorcontrib><creatorcontrib>Seibold, Laura</creatorcontrib><creatorcontrib>Heumann, Christian</creatorcontrib><creatorcontrib>Gnandt, Erhard</creatorcontrib><creatorcontrib>Röder, Miriam</creatorcontrib><creatorcontrib>Ruf, Sabine</creatorcontrib><title>Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part I: photographic data evaluation</title><title>European journal of orthodontics</title><addtitle>Eur J Orthod</addtitle><description>White spot lesions (WSLs) are a frequent side-effect of multibracket appliance treatment. The effect of local fluoridation on post-orthodontic WSL is however inconclusive.
Assessment of WSL changes in response to weekly 1.25 per cent fluoride gel application after multibracket appliance treatment.
Randomized, single-centre, double-blind, parallel-group, placebo-controlled study.
Patients with not less than 1 WSL (modified score 1 or 2) on not less than 1 upper front teeth after debonding.
Professional fluoride/placebo gel application during weeks 1-2; self-administered home application (weeks 3-24).
Photographic WSL assessment (dimension and luminance) of the upper front teeth (T0-T5).
Random assignment to test (n = 23) or placebo group (n = 23) using a sequentially numbered list (random allocation sequence generated for 50 subjects in 25 blocks of 2 subjects each).
The clinical study duration lasted from March 2011 to September 2013.
Unblinding was performed after complete data evaluation.
Intent-to-treat analysis set comprising 39 participants (test: n = 21, placebo: n = 18).
Dimensional WSL quantification showed limited reliability. Luminance improvement (%) of WSL, however, was seen after 6 months (test/placebo: tooth 12, 24.8/18.0; tooth 11, 38.4/35.4; tooth 21, 39.6/38.3; and tooth 22, 15.2/25.0). No statistically significant group difference existed. Data suggest that WSLs are difficult to measure with respect to reliability and repeatability and methods for monitoring WSLs in clinical trials require improvement/validation.
Similar adverse events occurred in both groups; none was classified as possibly related to the study product.
The number of dropouts was higher than expected and the socio-economic status was not assessed. Furthermore, the unknown level of compliance during the home application phase must be considered as limitation.
Based on the results of this study, no difference could be detected with respect to the development of WSL under post-orthodontic high-dose fluoride treatment.
The study was registered with ClinicalTrials.gov (Identifier: NCT01329731).
The protocol wasn't published before trial commencement.</description><subject>Adolescent</subject><subject>Bicuspid - pathology</subject><subject>Cariostatic Agents - administration & dosage</subject><subject>Cariostatic Agents - therapeutic use</subject><subject>Child</subject><subject>Cuspid - pathology</subject><subject>Dental Caries - drug therapy</subject><subject>Dental Caries - etiology</subject><subject>Dentistry</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Fluorides, Topical - administration & dosage</subject><subject>Fluorides, Topical - therapeutic use</subject><subject>Humans</subject><subject>Male</subject><subject>Orthodontic Brackets - adverse effects</subject><subject>Photography, Dental - methods</subject><subject>Reproducibility of Results</subject><subject>Tooth Remineralization - methods</subject><issn>0141-5387</issn><issn>1460-2210</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><recordid>eNo9kcuO1DAQRS0EYpqGDR-AaomQ0mPHebjZoRaPkUaCBawjxyl33Di2sZ1pDd_IR2HogVVJVaduXdUl5CWjO0b3_BpP_lqdzrSjj8iGNR2t6prRx2RDWcOqlov-ijxL6UQp5aLpn5Kruu9pLWi3Ib8Os3RHTGAcnGeTEVLwGSwm410C7a31Z-OOEHzKlY959pN32Sg4I3639yBDsEbJXHDwGtiubiFgBIUug7arj2ZCOKIFf1faHSxlfU6VhCjd5BfzEycIViocfaXKLJaTpaWscUXXQo5G2h18kTHDzVsIs8_-GGWYi4dJZgl4J-3618Bz8kRLm_DFQ92Sbx_efz18qm4_f7w5vLutFK95rngvOq2Y2Avd61HhpPfNXqq-1U3X1rxnimmhx1Zjh8ikmAQ2bVNLoQtZ05FvyeuLboj-x4opD4tJCq2VDv2aBiZ4y9tWlH9vyZsLqqJPKaIeQjSLjPcDo8Of9IaS3nBJr8CvHnTXccHpP_ovLv4bBZqb5A</recordid><startdate>20170401</startdate><enddate>20170401</enddate><creator>Bock, Niko C</creator><creator>Seibold, Laura</creator><creator>Heumann, Christian</creator><creator>Gnandt, Erhard</creator><creator>Röder, Miriam</creator><creator>Ruf, Sabine</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20170401</creationdate><title>Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part I: photographic data evaluation</title><author>Bock, Niko C ; Seibold, Laura ; Heumann, Christian ; Gnandt, Erhard ; Röder, Miriam ; Ruf, Sabine</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c323t-3786fc1898f7fbcedf949ac75f4652371c1f8fb5fe6ee1a8d8e4542a8fdf920b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adolescent</topic><topic>Bicuspid - pathology</topic><topic>Cariostatic Agents - administration & dosage</topic><topic>Cariostatic Agents - therapeutic use</topic><topic>Child</topic><topic>Cuspid - pathology</topic><topic>Dental Caries - drug therapy</topic><topic>Dental Caries - etiology</topic><topic>Dentistry</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Fluorides, Topical - administration & dosage</topic><topic>Fluorides, Topical - therapeutic use</topic><topic>Humans</topic><topic>Male</topic><topic>Orthodontic Brackets - adverse effects</topic><topic>Photography, Dental - methods</topic><topic>Reproducibility of Results</topic><topic>Tooth Remineralization - methods</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bock, Niko C</creatorcontrib><creatorcontrib>Seibold, Laura</creatorcontrib><creatorcontrib>Heumann, Christian</creatorcontrib><creatorcontrib>Gnandt, Erhard</creatorcontrib><creatorcontrib>Röder, Miriam</creatorcontrib><creatorcontrib>Ruf, Sabine</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>European journal of orthodontics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bock, Niko C</au><au>Seibold, Laura</au><au>Heumann, Christian</au><au>Gnandt, Erhard</au><au>Röder, Miriam</au><au>Ruf, Sabine</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part I: photographic data evaluation</atitle><jtitle>European journal of orthodontics</jtitle><addtitle>Eur J Orthod</addtitle><date>2017-04-01</date><risdate>2017</risdate><volume>39</volume><issue>2</issue><spage>134</spage><epage>143</epage><pages>134-143</pages><issn>0141-5387</issn><eissn>1460-2210</eissn><notes>ObjectType-Article-2</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-News-1</notes><notes>ObjectType-Feature-3</notes><notes>content type line 23</notes><abstract>White spot lesions (WSLs) are a frequent side-effect of multibracket appliance treatment. The effect of local fluoridation on post-orthodontic WSL is however inconclusive.
Assessment of WSL changes in response to weekly 1.25 per cent fluoride gel application after multibracket appliance treatment.
Randomized, single-centre, double-blind, parallel-group, placebo-controlled study.
Patients with not less than 1 WSL (modified score 1 or 2) on not less than 1 upper front teeth after debonding.
Professional fluoride/placebo gel application during weeks 1-2; self-administered home application (weeks 3-24).
Photographic WSL assessment (dimension and luminance) of the upper front teeth (T0-T5).
Random assignment to test (n = 23) or placebo group (n = 23) using a sequentially numbered list (random allocation sequence generated for 50 subjects in 25 blocks of 2 subjects each).
The clinical study duration lasted from March 2011 to September 2013.
Unblinding was performed after complete data evaluation.
Intent-to-treat analysis set comprising 39 participants (test: n = 21, placebo: n = 18).
Dimensional WSL quantification showed limited reliability. Luminance improvement (%) of WSL, however, was seen after 6 months (test/placebo: tooth 12, 24.8/18.0; tooth 11, 38.4/35.4; tooth 21, 39.6/38.3; and tooth 22, 15.2/25.0). No statistically significant group difference existed. Data suggest that WSLs are difficult to measure with respect to reliability and repeatability and methods for monitoring WSLs in clinical trials require improvement/validation.
Similar adverse events occurred in both groups; none was classified as possibly related to the study product.
The number of dropouts was higher than expected and the socio-economic status was not assessed. Furthermore, the unknown level of compliance during the home application phase must be considered as limitation.
Based on the results of this study, no difference could be detected with respect to the development of WSL under post-orthodontic high-dose fluoride treatment.
The study was registered with ClinicalTrials.gov (Identifier: NCT01329731).
The protocol wasn't published before trial commencement.</abstract><cop>England</cop><pmid>27702806</pmid><doi>10.1093/ejo/cjw060</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0141-5387 |
| ispartof | European journal of orthodontics, 2017-04, Vol.39 (2), p.134-143 |
| issn | 0141-5387 1460-2210 |
| language | eng |
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| source | Oxford University Press Journals |
| subjects | Adolescent Bicuspid - pathology Cariostatic Agents - administration & dosage Cariostatic Agents - therapeutic use Child Cuspid - pathology Dental Caries - drug therapy Dental Caries - etiology Dentistry Double-Blind Method Drug Administration Schedule Female Fluorides, Topical - administration & dosage Fluorides, Topical - therapeutic use Humans Male Orthodontic Brackets - adverse effects Photography, Dental - methods Reproducibility of Results Tooth Remineralization - methods |
| title | Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part I: photographic data evaluation |
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