White Spot LesionPhase 2NCT03865680

Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth

A Phase 2 study testing CPP-ACP and Duraphat in people with White Spot Lesion, run by Nourhan M.Aly at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this study is to evaluate the effectiveness of Casein phosphopeptide-amorphous calcium phosphate fluoride varnish (CPP-ACP FV) in comparison to fluoride varnish (FV) as a remineralizing agent for white spot lesions in primary teeth (WSLs). Read more about this study

Who is it for?: Ages 3 to 5 years
Conditions the study is for: White Spot Lesion
What is being tested?: CPP-ACP and Duraphat
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteEgypt
Study dates: 28 Apr 2019to 10 Apr 2020
Phase: Phase 2
Are there results?: None posted in the registry

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 3 to 5 years
All sexes
No healthy volunteers
Child

Who may be able to join

Healthy children with no systemic diseases.
High caries risk children with the presence of at least one visible active WSL in primary teeth with ICDAS II score of 1,2 or 3
Completion of a parental consent to participate in the study.

Who cannot join

Selected tooth with cavitated lesion.
Selected tooth with enamel defects.
Participants allergic to milk products.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry, Alexandria University
Alexandria, 21512

Other trials in Egypt

About this study

Official title: Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth (Randomized Clinical Trial)

Read the detailed description

The study is a two parallel arms double blinded randomized controlled clinical trial. A total of 180 WSL in primary teeth in chikdren aged 2-5 y and satisfying the inclusion criteria were selected. Patients will be randomly allocated into 2 groups allocated to two varnishes: study group: CPP-ACP FV (MI varnish), Control group FV (Duraphat). Both fluoride varnishes applications are applied with identical intensive protocols every 2 weeks for 6 weeks. The application of each varnish will be according to manufacturer's instructions. The operator is not blinded to treatment type. Only the participants and statistician are blinded to treatment groups. The whole sample (N=180) will be followed up at 6 weeks and at 18 and 30 weeks for Visio-tactile assessment and DIAGNOdent measurements

Conditions: White Spot Lesion
Being tested: CPP-ACP, Duraphat
Keywords: Fluoride varnish, Casein, MI varnish

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CPP-ACPDrug
Also called MI varnish, Casein phosphopeptide-amorphous calcium phosphate fluoride varnish
The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions.
DuraphatDrug
Also called Sodium Fluoride varnish
The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions.

Study groups in NCT03865680
Study group	Role	What they receive
MI varnish	Experimental	MI Fluoride varnish: 5% sodium fluoride varnish water based, sugar free containing RecaldentTM (CPP-ACP) (GC AMERICA INC.3737 West 127th Street, Alsip, IL 60803 U.S.A). The varnish will be applied at baseline 2 and 4 weeks on the whole set of teeth of the participants with partial cotton roll isolation , saliva ejector and according to the manufacturer's instructions. Participants will receive oral hygiene instructions, prophylaxis without paste. Receives: Drug: CPP-ACP
Duraphat Fluoride varnish	Active comparator	Duraphat Fluoride: varnish 5% sodium fluoride varnish (Colgate, New York, N.Y.). The varnish will be applied at baseline 2 and 4 weeks on the whole set of teeth of the participants with partial cotton roll isolation , saliva ejector and according to the manufacturer's instructions. Participants will receive oral hygiene instructions, prophylaxis without paste. Receives: Drug: Duraphat

What is being measured

The primary outcome is the main question the study is designed to answer.

Oral hygiene index (OHI-S) assessment
For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85). Each surface will take a score from 0-3. The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.
Measured: Baseline
Oral hygiene index (OHI-S) assessment
For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85). Each surface will take a score from 0-3. The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.
Measured: 6 weeks
Oral hygiene index (OHI-S) assessment
For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85). Each surface will take a score from 0-3. The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.
Measured: 18 weeks
Oral hygiene index (OHI-S) assessment
For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85). Each surface will take a score from 0-3. The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.
Measured: 30 weeks
Visio-tactile evaluation of the white spot lesion
Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream. Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.
Measured: Baseline
Visio-tactile evaluation of the white spot lesion
Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream. Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.
Measured: 6 weeks
Visio-tactile evaluation of the white spot lesion
Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream. Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.
Measured: 18 weeks
Visio-tactile evaluation of the white spot lesion
Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream. Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.
Measured: 30 weeks
White spot lesion evaluation using DIAGNOdent
Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent. It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power. Sound enamel does not fluoresce at this wavelength, but caries and bacteria do. The instrument is calibrated according to manufacturer's instructions. A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth. By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released. Zero baseline value has been set. Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely. Three measurements of each lesion will be taken and averaged to give the final score.
Measured: Baseline
White spot lesion evaluation using DIAGNOdent
Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent. It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power. Sound enamel does not fluoresce at this wavelength, but caries and bacteria do. The instrument is calibrated according to manufacturer's instructions. A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth. By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released. Zero baseline value has been set. Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely. Three measurements of each lesion will be taken and averaged to give the final score.
Measured: 6 weeks
White spot lesion evaluation using DIAGNOdent
Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent. It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power. Sound enamel does not fluoresce at this wavelength, but caries and bacteria do. The instrument is calibrated according to manufacturer's instructions. A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth. By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released. Zero baseline value has been set. Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely. Three measurements of each lesion will be taken and averaged to give the final score.
Measured: 18 weeks
White spot lesion evaluation using DIAGNOdent
Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent. It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power. Sound enamel does not fluoresce at this wavelength, but caries and bacteria do. The instrument is calibrated according to manufacturer's instructions. A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth. By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released. Zero baseline value has been set. Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely. Three measurements of each lesion will be taken and averaged to give the final score.
Measured: 30 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Apr 201910 Apr 2020

First posted7 Mar 2019
Study start28 Apr 2019
Primary completion25 Mar 2020
Study completion10 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for White Spot LesionStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: The study is a double blind randomized controlled clinical trial, with a 1:1 allocation ratio. Subjects are randomly assigned using a computer -generated list of random numbers to one of the two arms (MI varnish, Duraphat fluoride varnish).
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03865680
Sponsor's protocol ID: CPP-ACP FV on remineralization
Status last verified: Apr 2020
First submitted: 4 Mar 2019
Last updated: 22 Apr 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Willmot DR. White lesions after orthodontic treatment: does low fluoride make a difference? J Orthod. 2004 Sep;31(3):235-42; discussion 202. doi: 10.1179/146531204225022443.
PubMed 15489367
Llena C, Leyda AM, Forner L. CPP-ACP and CPP-ACFP versus fluoride varnish in remineralisation of early caries lesions. A prospective study. Eur J Paediatr Dent. 2015 Sep;16(3):181-6.
PubMed 26418918
Cochrane NJ, Shen P, Yuan Y, Reynolds EC. Ion release from calcium and fluoride containing dental varnishes. Aust Dent J. 2014 Mar;59(1):100-5. doi: 10.1111/adj.12144. Epub 2014 Feb 4.
PubMed 24494654
Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
PubMed 17518963
Miglani DC, Beal JF, James PM, Behari SA. The assessment of dental cleanliness status of the primary dentition using a modification of the simplified oral hygiene index(OHIS-M). J Indian Dent Assoc. 1973 Dec;45(12):385-8. No abstract available.
PubMed 4535076
Braga MM, Mendes FM, Ekstrand KR. Detection activity assessment and diagnosis of dental caries lesions. Dent Clin North Am. 2010 Jul;54(3):479-93. doi: 10.1016/j.cden.2010.03.006.
PubMed 20630191

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
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Not yet recruiting
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Recruiting
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All White Spot Lesion trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth (Randomized Clinical Trial)
ClinicalTrials.gov ID: NCT03865680
Acronym / sponsor ID: CPP-ACP FV on remineralization
Conditions: White Spot Lesion
Keywords: Fluoride varnish, Casein, MI varnish
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Nourhan M.AlyUniversity, hospital or other
Collaborators: Alexandria University
Study start: 28 Apr 2019 (actual)
Primary completion: 25 Mar 2020 (actual)
Study completion: 10 Apr 2020 (actual)
First posted: 7 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: The study is a double blind randomized controlled clinical trial, with a 1:1 allocation ratio. Subjects are randomly assigned using a computer -generated list of random numbers to one of the two arms (MI varnish, Duraphat fluoride varnish).

Arm	Type	Receives
MI varnish	Experimental	Drug: CPP-ACPMI Fluoride varnish: 5% sodium fluoride varnish water based, sugar free containing RecaldentTM (CPP-ACP) (GC AMERICA INC.3737 West 127th Street, Alsip, IL 60803 U.S.A). The varnish will be applied at baseline 2 and 4 weeks on the whole set of teeth of the participants with partial cotton roll isolation , saliva ejector and according to the manufacturer's instructions. Participants will receive oral hygiene instructions, prophylaxis without paste.
Duraphat Fluoride varnish	Active comparator	Drug: DuraphatDuraphat Fluoride: varnish 5% sodium fluoride varnish (Colgate, New York, N.Y.). The varnish will be applied at baseline 2 and 4 weeks on the whole set of teeth of the participants with partial cotton roll isolation , saliva ejector and according to the manufacturer's instructions. Participants will receive oral hygiene instructions, prophylaxis without paste.

Who may qualify

Ages: 3 to 5 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Healthy children with no systemic diseases.
High caries risk children with the presence of at least one visible active WSL in primary teeth with ICDAS II score of 1,2 or 3
Completion of a parental consent to participate in the study.

Key exclusion criteria (3 listed)

Selected tooth with cavitated lesion.
Selected tooth with enamel defects.
Participants allergic to milk products.

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
CPP-ACPAlso: MI varnish, Casein phosphopeptide-amorphous calcium phosphate fluoride varnishThe fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions.	Drug	MI varnish
DuraphatAlso: Sodium Fluoride varnishThe fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions.	Drug	Duraphat Fluoride varnish

Primary outcome

Oral hygiene index (OHI-S) assessment
Time frame: Baseline
For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85). Each surface will take a score from 0-3. The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.
Oral hygiene index (OHI-S) assessment
Time frame: 6 weeks
For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85). Each surface will take a score from 0-3. The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.
Oral hygiene index (OHI-S) assessment
Time frame: 18 weeks
For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85). Each surface will take a score from 0-3. The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.
Oral hygiene index (OHI-S) assessment
Time frame: 30 weeks
For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85). Each surface will take a score from 0-3. The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.
Visio-tactile evaluation of the white spot lesion
Time frame: Baseline
Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream. Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.
Visio-tactile evaluation of the white spot lesion
Time frame: 6 weeks
Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream. Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.
Visio-tactile evaluation of the white spot lesion
Time frame: 18 weeks
Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream. Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.
Visio-tactile evaluation of the white spot lesion
Time frame: 30 weeks
Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream. Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.
White spot lesion evaluation using DIAGNOdent
Time frame: Baseline
Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent. It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power. Sound enamel does not fluoresce at this wavelength, but caries and bacteria do. The instrument is calibrated according to manufacturer's instructions. A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth. By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released. Zero baseline value has been set. Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely. Three measurements of each lesion will be taken and averaged to give the final score.
White spot lesion evaluation using DIAGNOdent
Time frame: 6 weeks
Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent. It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power. Sound enamel does not fluoresce at this wavelength, but caries and bacteria do. The instrument is calibrated according to manufacturer's instructions. A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth. By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released. Zero baseline value has been set. Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely. Three measurements of each lesion will be taken and averaged to give the final score.
White spot lesion evaluation using DIAGNOdent
Time frame: 18 weeks
Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent. It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power. Sound enamel does not fluoresce at this wavelength, but caries and bacteria do. The instrument is calibrated according to manufacturer's instructions. A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth. By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released. Zero baseline value has been set. Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely. Three measurements of each lesion will be taken and averaged to give the final score.
White spot lesion evaluation using DIAGNOdent
Time frame: 30 weeks
Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent. It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power. Sound enamel does not fluoresce at this wavelength, but caries and bacteria do. The instrument is calibrated according to manufacturer's instructions. A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth. By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released. Zero baseline value has been set. Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely. Three measurements of each lesion will be taken and averaged to give the final score.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
Background: PubMed 15489367Willmot DR. White lesions after orthodontic treatment: does low fluoride make a difference? J Orthod. 2004 Sep;31(3):235-42; discussion 202. doi: 10.1179/146531204225022443.
Background: PubMed 26418918Llena C, Leyda AM, Forner L. CPP-ACP and CPP-ACFP versus fluoride varnish in remineralisation of early caries lesions. A prospective study. Eur J Paediatr Dent. 2015 Sep;16(3):181-6.
Background: PubMed 24494654Cochrane NJ, Shen P, Yuan Y, Reynolds EC. Ion release from calcium and fluoride containing dental varnishes. Aust Dent J. 2014 Mar;59(1):100-5. doi: 10.1111/adj.12144. Epub 2014 Feb 4.
Background: PubMed 17518963Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
Background: PubMed 4535076Miglani DC, Beal JF, James PM, Behari SA. The assessment of dental cleanliness status of the primary dentition using a modification of the simplified oral hygiene index(OHIS-M). J Indian Dent Assoc. 1973 Dec;45(12):385-8. No abstract available.
Background: PubMed 20630191Braga MM, Mendes FM, Ekstrand KR. Detection activity assessment and diagnosis of dental caries lesions. Dent Clin North Am. 2010 Jul;54(3):479-93. doi: 10.1016/j.cden.2010.03.006.

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Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
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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.

Ahmed I Mekky, BDS principal investigator

Alexandria University

Karin ML Dowidar, PhD study director

Alexandria University

Dalia AM Talaat, PhD study director

Alexandria University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CPP-ACP and Duraphat in people with White Spot Lesion, run by Nourhan M.Aly at 1 site in Egypt.

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 3 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 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Oral hygiene index (OHI-S) assessment (time frame: Baseline). The study lists 12 primary outcomes in all. 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 NCT03865680, which also lists 6 linked publications.

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 22 Apr 2020.