Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06051981
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-25
First Post:
2023-09-18
Brief Title:
White Spot Lesions Treatment in Orthodontic
Sponsor:
Riyadh Elm University
Organization:
Riyadh Elm University
Study Overview
Official Title:
The Effect of Fluoride Varnish Casein Phosphopeptide-Amorphous Calcium Phosphate and Resin Infiltration in the Treatment of White Spot Lesions After Orthodontic Therapy A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WSL
Brief Summary:
The study aims to investigate the effectiveness of a new treatment for demineralized white spot lesions WSLs after fixed appliance therapy The trial will consist of four parallel groups control Fluoride Varnish FV Casein Phosphopeptide-Amorphous Calcium Phosphate CPP-ACP and Resin Infiltration RI groups Patients will be recruited from Riyadh Elm Universitys electronic record system and contacted by phone They will be given an appointment to visit the dental clinic
A total of 22 patients with WSLs will be selected for the study Two examiners will perform dental examinations using a dental mirror and a ball-ended probe to code the WSL against the ICDAS system The level of agreement between the two examiners will be assessed using reliability analysis with an agreement level of above 80 considered
Buccal WSLs will be defined as those that extend from the center of the buccal to either the mesial or distal surface WSLs coded 3 or higher will be excluded from further examination and treated accordingly
A total of 22 patients with WSLs will be selected for the study Two examiners will perform dental examinations using a dental mirror and a ball-ended probe to code the WSL against the ICDAS system The level of agreement between the two examiners will be assessed using reliability analysis with an agreement level of above 80 considered
Buccal WSLs will be defined as those that extend from the center of the buccal to either the mesial or distal surface WSLs coded 3 or higher will be excluded from further examination and treated accordingly
Detailed Description:
Trial design The study will be conducted as a prospective clinical controlled trial with an experimental design consisting of four parallel groups Individuals who experienced the development of demineralized white spot lesions after undergoing fixed appliance therapy will be invited to participate in the study and will be assigned to one of the following groups control group Fluoride Varnish FV group Casein Phosphopeptide-Amorphous Calcium Phosphate CPP-ACP group or Resin Infiltration RI group
Participants Patients will be recruited by navigating the electronic record system of Riyadh Elm University from 2023 files backward up to 2022 identifying patients who completed orthodontic treatment reaching up to the required sample size Those patients will be contacted by phone call from the dental clinic of Riyadh Elm University official number inviting them to participate in the current study Patients will be given an appointment to visit the dental clinic at specific time Before enrollment every patient or parentlegal guardian of a patient younger than 18 years of age will receive an informational letter and verbal communication about the objectives and protocol of the study All enrolled patients andor their parents or legal guardians will be asked to provide a written informed consent following their initial approval All patients who got treatment in Riyadh Elm University signed consents to share their information for research purposes will be enrolled in the study
Calibration exercise A total of 22 patients with WSLs attending dental clinics of REU will be selected and two examiners will perform dental examinations using a dental mirror and a ball-ended probe on wet and dry debris-free teeth to code the WSL against the ICDAS system Whenever in doubt regarding the coding of the WSLs the third expert examiner decision will be considered final The level of agreement with regard to the ICDAS codes between the two examiners will be assessed using reliability analysis and the agreement level of above 80 will be considered
Two examiners will perform dental examinations using a dental mirror and a ball-ended probe on wet and dry debris-free teeth Each WSL will be identified by visual inspection of mesiobuccal buccal or distobuccal tooth surfaces and recorded An ICDAS code will be assigned to each WSL A digital photograph will be taken by keeping 45 cm distance between subject and camera The digital image of WS can be captured with a digital camera Canon EOS 2000D NIS DSLR Camera 18 - 55 mm NIS Lens held almost perpendicular to the buccal surface Light is supplied by a flash mounted around lens The camera system setup was adjusted as follows the quality of image is Fine ISO is 200 and white balance is speed light mode Moreover dental status of the participants also recorded
Buccal WSLs will be defined as those that extend from the center of the buccal to either the mesial surface or the distal surface WSLs that will be coded 3 denoted by localized enamel breakdown caused by caries without the presence of dentin and underlying shadow or higher denoted by the presence of underlying dark shadow caused by dentin whether enamel-depleting or not to a large distinct cavity containing visible dentin in accordance with ICDAS reference are excluded from further examination and will be appropriately treated
Following the determination of the 0 LF value for each tooth on a healthy surface the maximum LF value for each WSL coded tooth either 1 or 2 will be determined using a DIAGNODent flat tip KaVo dental GmbH Biberach Germany Measurements will be done according to the manufacturers instructions Each tooth will be dried for 5 seconds and the tip will be pointed in the opposite direction from the examination area The measurement will be done using the DIAGNOdent Scale values 013 no caries values 1420 enamel caries and values 20 dentinal caries Lussi et al 2001
Eligibility criteria for participants Inclusion criteria
1 Post orthodontic patients with one WSLs on buccal surface of tooth with ICDAS Code 1 or 2
2 Agreeing to participate in the study by singing the study informed consent
3 For younger patients parents agree to provide consent for child participation in the study
Exclusion criteria
1 Developmental defects of dental hard tissue
2 Patients who have systemic disease or under medications that usually cause an increased risk of oral caries
3 Patients who are allergic to Fluoride varnish CPP-ACP and resin infiltration Study settings Data will be collected from orthodontic clinics of Namouthajya and Muneseya hospitals at Riyadh Elm University Riyadh Saudi Arabia
Intervention In group I Control group FV EnamelastTM a flavored xylitol-sweetened 5 sodium fluoride in a resin carrier delivered in a 12 ml syringe or in a 04 ml unit Ultradent USA will be applied on all teeth according to the manufacturers instructions compressed air and cotton rolls will be used to dry the teeth A mini brush will be used to apply varnish to all teeth surfaces The varnish will be left to dry for one minute Patients should avoid eating drinking or brushing for a period of 3-4 hours following the application of varnish In the test groups group II Intensive FV will be applied three times a week for a week every two days For group III CPP-ACP Tooth Mousse MI Paste GC Corporation Tokyo Japan for 12 weeks A thin layer from Tooth Mousse will be applied to the teeth after daily brushing with traditional toothpaste and left intact for 180 seconds before rinsing with distilled water Thierens et al 2019 For group IV ICON DMG Hamburg Germany resin infiltration will be applied as specified by the manufacturer the 15 hydrochloric acid HCL solution will be sprayed for 2 minutes followed by rinsing with water for 30 seconds and drying Application of ICON-Dry Ethanol for 30 seconds followed by air drying Subsequently ICON-Infiltration will be applied to the tooth surface and left for 3 minutes The excess resin will be removed using a cotton roll followed by a light curing process lasting for 40 seconds Finally the enamel surface that has been roughened will be polished with composite resin polish discs and polish cups
Participants Patients will be recruited by navigating the electronic record system of Riyadh Elm University from 2023 files backward up to 2022 identifying patients who completed orthodontic treatment reaching up to the required sample size Those patients will be contacted by phone call from the dental clinic of Riyadh Elm University official number inviting them to participate in the current study Patients will be given an appointment to visit the dental clinic at specific time Before enrollment every patient or parentlegal guardian of a patient younger than 18 years of age will receive an informational letter and verbal communication about the objectives and protocol of the study All enrolled patients andor their parents or legal guardians will be asked to provide a written informed consent following their initial approval All patients who got treatment in Riyadh Elm University signed consents to share their information for research purposes will be enrolled in the study
Calibration exercise A total of 22 patients with WSLs attending dental clinics of REU will be selected and two examiners will perform dental examinations using a dental mirror and a ball-ended probe on wet and dry debris-free teeth to code the WSL against the ICDAS system Whenever in doubt regarding the coding of the WSLs the third expert examiner decision will be considered final The level of agreement with regard to the ICDAS codes between the two examiners will be assessed using reliability analysis and the agreement level of above 80 will be considered
Two examiners will perform dental examinations using a dental mirror and a ball-ended probe on wet and dry debris-free teeth Each WSL will be identified by visual inspection of mesiobuccal buccal or distobuccal tooth surfaces and recorded An ICDAS code will be assigned to each WSL A digital photograph will be taken by keeping 45 cm distance between subject and camera The digital image of WS can be captured with a digital camera Canon EOS 2000D NIS DSLR Camera 18 - 55 mm NIS Lens held almost perpendicular to the buccal surface Light is supplied by a flash mounted around lens The camera system setup was adjusted as follows the quality of image is Fine ISO is 200 and white balance is speed light mode Moreover dental status of the participants also recorded
Buccal WSLs will be defined as those that extend from the center of the buccal to either the mesial surface or the distal surface WSLs that will be coded 3 denoted by localized enamel breakdown caused by caries without the presence of dentin and underlying shadow or higher denoted by the presence of underlying dark shadow caused by dentin whether enamel-depleting or not to a large distinct cavity containing visible dentin in accordance with ICDAS reference are excluded from further examination and will be appropriately treated
Following the determination of the 0 LF value for each tooth on a healthy surface the maximum LF value for each WSL coded tooth either 1 or 2 will be determined using a DIAGNODent flat tip KaVo dental GmbH Biberach Germany Measurements will be done according to the manufacturers instructions Each tooth will be dried for 5 seconds and the tip will be pointed in the opposite direction from the examination area The measurement will be done using the DIAGNOdent Scale values 013 no caries values 1420 enamel caries and values 20 dentinal caries Lussi et al 2001
Eligibility criteria for participants Inclusion criteria
1 Post orthodontic patients with one WSLs on buccal surface of tooth with ICDAS Code 1 or 2
2 Agreeing to participate in the study by singing the study informed consent
3 For younger patients parents agree to provide consent for child participation in the study
Exclusion criteria
1 Developmental defects of dental hard tissue
2 Patients who have systemic disease or under medications that usually cause an increased risk of oral caries
3 Patients who are allergic to Fluoride varnish CPP-ACP and resin infiltration Study settings Data will be collected from orthodontic clinics of Namouthajya and Muneseya hospitals at Riyadh Elm University Riyadh Saudi Arabia
Intervention In group I Control group FV EnamelastTM a flavored xylitol-sweetened 5 sodium fluoride in a resin carrier delivered in a 12 ml syringe or in a 04 ml unit Ultradent USA will be applied on all teeth according to the manufacturers instructions compressed air and cotton rolls will be used to dry the teeth A mini brush will be used to apply varnish to all teeth surfaces The varnish will be left to dry for one minute Patients should avoid eating drinking or brushing for a period of 3-4 hours following the application of varnish In the test groups group II Intensive FV will be applied three times a week for a week every two days For group III CPP-ACP Tooth Mousse MI Paste GC Corporation Tokyo Japan for 12 weeks A thin layer from Tooth Mousse will be applied to the teeth after daily brushing with traditional toothpaste and left intact for 180 seconds before rinsing with distilled water Thierens et al 2019 For group IV ICON DMG Hamburg Germany resin infiltration will be applied as specified by the manufacturer the 15 hydrochloric acid HCL solution will be sprayed for 2 minutes followed by rinsing with water for 30 seconds and drying Application of ICON-Dry Ethanol for 30 seconds followed by air drying Subsequently ICON-Infiltration will be applied to the tooth surface and left for 3 minutes The excess resin will be removed using a cotton roll followed by a light curing process lasting for 40 seconds Finally the enamel surface that has been roughened will be polished with composite resin polish discs and polish cups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None