White Spot Lesion of ToothNCT03721198
RMGI Varnish Versus APF Gel in Prevention of White Spot Lesions During Orthodontic Treatment
A study testing Acidulated phosphorous flouride and Resin modified glass ionomer varnish in people with White Spot Lesion of Tooth, run by Mohamed zidan.
Trial summary
evaluate the effect of a single application of Clinpro XT varnish on enamel demineralization adjacent to orthodontic brackets during fixed orthodontic treatment in comparison with acidulated phosphorus fluoride gel. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- Acidulated phosphorous flouride and Resin modified glass ionomer varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Oct 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient indicating for fixed orthodontic treatment with healthy gingival and periodontal condition
Who cannot join
- Presence of enamel hypoplasia or dental fluorosis.
- Presence of tetracycline pigmentation.
- Periodontal pocketing of 3mm or greater.
- Presence of carious cavities.
- Smokers.
- Allergy to fluoride gel being used in study.
- Patient that have systemic disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Resin-modified Glass Ionomer Varnish Versus Acidulated Phosphorus Fluoride Gel in Prevention of White Spot Lesions During Comprehensive Orthodontic Treatment: (Split Mouth Randomized Clinical Trial)(A Comparative Study)
evaluate the effect of a single application of Clinpro XT varnish on enamel demineralization adjacent to orthodontic brackets during fixed orthodontic treatment in comparison with acidulated phosphorus fluoride gel.
this study is to assess the durability of the results obtained from both materials (Clinpro XT Varnish- APF Gel) this study is to determine the degree of
patients' satisfaction after the use of both materials (Clinpro XT Varnish -
APF Gel)
Read the detailed description
This clinical study will be held in the orthodontic clinic, Faculty of dentistry, Cairo University, Egypt Principal investigator (MZ) will select and examine the patients according to the inclusion criteria.
Tooth preparation procedure:
Excessive saliva in Upper six anterior teeth will be removed by cotton rolls or by using an air syringe without excessive drying. Principal investigator (MZ) will take a photograph for each tooth using A Digital DSLR camera (canon 700d with lens 100 macro 2.8) and this photograph is T0(before application of the gel)
Intervention and comparator:
- Bonding procedure before application of intervention and comparator Upper six anterior teeth will be cleaned with pumice, rinsed and dried thoroughly. The area where the bracket is to be placed will be etched with a 37% orthophosphoric acid gel for 15 seconds and then rinsed with water. After rinsing, the enamel surface will be dried with compressed moisture and oil free air. A layer of primer will be applied to the tooth and bracket mesh. Adhesive paste will be applied to the base of the bracket and pressed firmly onto the tooth surface. Excess adhesive will be removed, and the adhesive light cured for 20 seconds.
- Preparation of clinpro XT (intervention) In upper right anterior teeth, the polished tooth surface is etched using 37% orthophosphoric acid gel. applied for 15 seconds over the labial enamel surface extending from gingival surface of the bracket to the free gingival margin. Then, the surface is rinsed thoroughly by water spray and dried with compressed moisture and oil free air to remove the etchant. The paste and liquid components of the varnish are mixed on a paper pad for 10-15 seconds by a small plastic spatula. When the mix material appears glossy and smooth in consistency, it is applied as a thin layer over the etched enamel surface by a ball applicator. Care should be taken to avoid prolonged contact of uncured material with soft tissues. If accidental contact occurred, the material is immediately wiped off with wet cotton roll. Then, the varnish is light cured with the visible light-curing unit for 20 s.Oral hygiene instruction will be given to the patient e.g. tooth brushing twice a day with fluoride toothpaste. A photograph will be taken for the labial surface of each upper right anterior tooth using the same camera by the outcome assessor (MS) after 3 months (T1) and 6 months (T2) of orthodontic treatment.
- Preparation of Acidulated Phosphorus Fluoride (Comparator):
Acidulated Phosphorus Fluoride gel will be applied directly over the labial enamel surface extending from gingival surface of the bracket to the free gingival margin using a small brush/swab to spread the gel over the surface. The gel will be left in place for four minutes then washed. Patients will be instructed not to rinse, eat, drink or smoke for the next 30 minutes.
- Conditions
- White Spot Lesion of Tooth
- Being tested
- Acidulated phosphorous flouride, Resin modified glass ionomer varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acidulated phosphorous flourideCombination product
Also called APF
Acidulated phosphorous flouride is used to prevent white spot lesions
Resin modified glass ionomer varnishOther
Also called CLINPRO XT
Resin modified glass ionomer varnish is used to prevent white spot lesions
| Study group | Role | What they receive |
|---|---|---|
| Acidulated phosphorous flouride | Active comparator | Acidulated phosphorous flouride used once at the first of the study Receives: Combination Product: Acidulated phosphorous flouride |
| Resin modified glass ionomer varnish | Experimental | Resin modified glass ionomer varnish (CLINPRO XT ) is used once at the first of the study only Receives: Other: Resin modified glass ionomer varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colour change
Colour change using spectrophotometer
Measured: 6 months
Secondary outcomes (1)
Colour stability
Colour stability using spectrophotometer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study startMar 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot Lesion of ToothStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split mouth technique
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed zidan
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Mohamed zidan, Cairo University
- Investigators
- mohamed Saied, Study chair, orthodontic department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721198
- Sponsor's protocol ID
- RMGI Varnish-WSL prevention
- Status last verified
- Mar 2019
- First submitted
- 22 Oct 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resin-modified Glass Ionomer Varnish Versus Acidulated Phosphorus Fluoride Gel in Prevention of White Spot Lesions During Comprehensive Orthodontic Treatment: (Split Mouth Randomized Clinical Trial)(A Comparative Study)
- ClinicalTrials.gov ID
- NCT03721198
- Acronym / sponsor ID
- RMGI Varnish-WSL prevention
- Conditions
- White Spot Lesion of Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Mohamed zidanUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Mar 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 26 Oct 2018 (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.
evaluate the effect of a single application of Clinpro XT varnish on enamel demineralization adjacent to orthodontic brackets during fixed orthodontic treatment in comparison with acidulated phosphorus fluoride gel.
this study is to assess the durability of the results obtained from both materials (Clinpro XT Varnish- APF Gel) this study is to determine the degree of
patients' satisfaction after the use of both materials (Clinpro XT Varnish -
APF Gel)
Detailed description
This clinical study will be held in the orthodontic clinic, Faculty of dentistry, Cairo University, Egypt Principal investigator (MZ) will select and examine the patients according to the inclusion criteria.
Tooth preparation procedure:
Excessive saliva in Upper six anterior teeth will be removed by cotton rolls or by using an air syringe without excessive drying. Principal investigator (MZ) will take a photograph for each tooth using A Digital DSLR camera (canon 700d with lens 100 macro 2.8) and this photograph is T0(before application of the gel)
Intervention and comparator:
- Bonding procedure before application of intervention and comparator Upper six anterior teeth will be cleaned with pumice, rinsed and dried thoroughly. The area where the bracket is to be placed will be etched with a 37% orthophosphoric acid gel for 15 seconds and then rinsed with water. After rinsing, the enamel surface will be dried with compressed moisture and oil free air. A layer of primer will be applied to the tooth and bracket mesh. Adhesive paste will be applied to the base of the bracket and pressed firmly onto the tooth surface. Excess adhesive will be removed, and the adhesive light cured for 20 seconds.
- Preparation of clinpro XT (intervention) In upper right anterior teeth, the polished tooth surface is etched using 37% orthophosphoric acid gel. applied for 15 seconds over the labial enamel surface extending from gingival surface of the bracket to the free gingival margin. Then, the surface is rinsed thoroughly by water spray and dried with compressed moisture and oil free air to remove the etchant. The paste and liquid components of the varnish are mixed on a paper pad for 10-15 seconds by a small plastic spatula. When the mix material appears glossy and smooth in consistency, it is applied as a thin layer over the etched enamel surface by a ball applicator. Care should be taken to avoid prolonged contact of uncured material with soft tissues. If accidental contact occurred, the material is immediately wiped off with wet cotton roll. Then, the varnish is light cured with the visible light-curing unit for 20 s.Oral hygiene instruction will be given to the patient e.g. tooth brushing twice a day with fluoride toothpaste. A photograph will be taken for the labial surface of each upper right anterior tooth using the same camera by the outcome assessor (MS) after 3 months (T1) and 6 months (T2) of orthodontic treatment.
- Preparation of Acidulated Phosphorus Fluoride (Comparator):
Acidulated Phosphorus Fluoride gel will be applied directly over the labial enamel surface extending from gingival surface of the bracket to the free gingival margin using a small brush/swab to spread the gel over the surface. The gel will be left in place for four minutes then washed. Patients will be instructed not to rinse, eat, drink or smoke for the next 30 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- split mouth technique
| Arm | Type | Receives |
|---|---|---|
| Acidulated phosphorous flouride | Active comparator | Combination Product: Acidulated phosphorous flourideAcidulated phosphorous flouride used once at the first of the study |
| Resin modified glass ionomer varnish | Experimental | Other: Resin modified glass ionomer varnishResin modified glass ionomer varnish (CLINPRO XT ) is used once at the first of the study only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient indicating for fixed orthodontic treatment with healthy gingival and periodontal condition
Key exclusion criteria (7 listed)
- Presence of enamel hypoplasia or dental fluorosis.
- Presence of tetracycline pigmentation.
- Periodontal pocketing of 3mm or greater.
- Presence of carious cavities.
- Smokers.
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 |
|---|---|---|
| Acidulated phosphorous flourideAlso: APFAcidulated phosphorous flouride is used to prevent white spot lesions | Combination product | Acidulated phosphorous flouride |
| Resin modified glass ionomer varnishAlso: CLINPRO XTResin modified glass ionomer varnish is used to prevent white spot lesions | Other | Resin modified glass ionomer varnish |
Primary outcome
Colour change
Time frame: 6 months
Colour change using spectrophotometer
1 secondary outcome
Colour stability
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
mohamed Saied study chair
orthodontic department
Questions about this trial
What is this clinical trial studying?
A study testing Acidulated phosphorous flouride and Resin modified glass ionomer varnish in people with White Spot Lesion of Tooth, run by Mohamed zidan.
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 1 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: status not confirmed, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Zidan, BDS (01157625577, Dr_mhmdzidan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colour change (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2019.