White Spot Lesion of ToothPhase 4NCT03217084
Treatment of Postorthodontic White Spot Lesions
A Phase 4 study testing MI varnish GC and White varnish 3M in people with White Spot Lesion of Tooth, run by Cairo University at 1 site in Egypt.
Trial summary
Dental caries is the destruction of the tooth structure in the presence of organic acids produced by cariogenic bacteria located in the dental biofilm (Dowker et al., 1999 and Robinson et al., 2000).Tooth enamel comprises 90% substituted hydroxyapatite (Ca10 (PO4)6(OH) 2), which is subjected to consecutive cycles of… Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- MI varnish GC and White varnish 3M
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Dec 2017to Dec 2018
- Phase
- Phase 4
- 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 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age ranging 11-16 years.
- Good general health.
- Exhibiting at least 2 white spot lesion in buccal surface of their teeth.
Who cannot join
- Chronic use of medication causing dry mouth.
- Oral ulcer, ulcerous gingivitis, acute bronchial asthma.
- History of allergic reaction to fluoride or other ingredients in varnish.
- Refusal of the patient to participate in the trial.
- Any previous treatment done for white spot lesion.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry Cairo University
Al Manyal, Cairo Governorate, 11562
Abdelrahman Al-Duqi, Bsc, +201145511131, abdulrahman.alduqi@dentistry.cu.edu.eg
Fatma Abdelgawad, PhD, ±201006753265, fatmadent@hotmail.com
About this study
Official title: Esthetic Effect of Casein Phosphopeptide-Amorphous Calcium Phosphate Varnish Versus Tricalcium Phosphate Varnish on Postorthodontic White Spot Lesions: A Randomized Pilot Study
Dental caries is the destruction of the tooth structure in the presence of organic acids produced by cariogenic bacteria located in the dental biofilm (Dowker et al., 1999 and Robinson et al., 2000).Tooth enamel comprises 90% substituted hydroxyapatite (Ca10 (PO4)6(OH) 2), which is subjected to consecutive cycles of demineralization and remineralization. This is an interrupted process, with periods of remineralization and demineralization occurring, depending on the state of the oral environment in terms of the prolonged accumulation and retention of bacterial plaque on the enamel surface (Aoba, 2004).
Oral bacteria ferment carbohydrates to produce organic acids which lower the pH and cause the subsurface dissolution of the hydroxyapatite crystals. Under normal physiological conditions (pH7), saliva is supersaturated with calcium and phosphate ions which diffuse into the vacancies created during acid-mediated demineralization episodes (Dowker et al., 1999 and Robinson et al., 2000). The demineralization of enamel (white spot lesions) is a significant problem during and after orthodontic treatment with prevalence 71.1% and various preventive measures have been suggested to minimize the incidence (Derks et al., 2004 and Al Maaitah et al., 2011).
Read the detailed description
In orthodontic patients, demineralization usually takes place in the form of white or brown spots on the enamel around the brackets and can lead to cavitation (Al Maaitah et al., 2011). White spot lesions compromise esthetics and can be extremely difficult or even impossible to reverse.
Natural remineralization through saliva involving a mineral gain in the surface layer of white spot lesions has little improvement on the esthetic and structural properties of the deeper lesions (Karlinsey et al., 2009 and Cochrane et al., 2010). Management of white spot lesion should involve methods of both preventing demineralization and encourage the remineralization of existing lesions. In both of these processes, the efficacy of fluoride is well established. Fluoride increases the initial rate of remineralization of early enamel lesions. Consequently, it slows down the caries process and arresting the lesion. Fluoride varnish provides a protective coat over the tooth which adheres longer to the tooth surface (Demito et al., 2004 and Ten Cate et al., 2008).
- Conditions
- White Spot Lesion of Tooth
- Being tested
- MI varnish GC, White varnish 3M
- Keywords
- White spot lesion ,fluoride varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI varnish GCDrug
Also called Fluoride Varnish
MI Varnish GC is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. MI Varnish also contains RECALDENT. Open the unit-dose package of Varnish. Use the applicator brush to thoroughly mix Varnish. Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue. The treatment period for Varnish is minimally 4 hour.
White varnish 3MDrug
Also called Fluoride Varnish
White varnish 3M is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. Clinpro White Varnish contains an innovative tri-calcium phosphate.Open the unit-dose package of Varnish and dispense the entire content onto the round application guide provided with the packet. Use the applicator brush to thoroughly mix Varnish. Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue. The treatment period for Varnish is minimally 4 hour.
| Study group | Role | What they receive |
|---|---|---|
| MI varnish GC | Active comparator | MI Varnish is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. MI Varnish also contains RECALDEN Open the unit-dose package of Varnish. Use the applicator brush to thoroughly mix Varnish . Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue. Receives: Drug: MI varnish GC |
| White Varnish 3M | Active comparator | White Varnish is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. White Varnish an innovative tri-calcium phosphate.
Open the unit-dose package of Varnish. Use the applicator brush to thoroughly mix Varnish . Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue. Receives: Drug: White varnish 3M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esthetic effect
Asking patient (yes or No)
Measured: 6 months
Secondary outcomes (1)
Clinical assessment
International Caries Detection and Assessment System (ICDAS II) by score
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 posted13 Jul 2017
- Study start17 Dec 2017
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Yousef ALduqi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217084
- Sponsor's protocol ID
- FODM CU
- Status last verified
- Feb 2018
- First submitted
- 12 Jul 2017
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Effect of Casein Phosphopeptide-Amorphous Calcium Phosphate Varnish Versus Tricalcium Phosphate Varnish on Postorthodontic White Spot Lesions: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03217084
- Acronym / sponsor ID
- FODM CU
- Conditions
- White Spot Lesion of Tooth
- Keywords
- White spot lesion ,fluoride varnish
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Dec 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Jul 2017 (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.
Dental caries is the destruction of the tooth structure in the presence of organic acids produced by cariogenic bacteria located in the dental biofilm (Dowker et al., 1999 and Robinson et al., 2000).Tooth enamel comprises 90% substituted hydroxyapatite (Ca10 (PO4)6(OH) 2), which is subjected to consecutive cycles of demineralization and remineralization. This is an interrupted process, with periods of remineralization and demineralization occurring, depending on the state of the oral environment in terms of the prolonged accumulation and retention of bacterial plaque on the enamel surface (Aoba, 2004).
Oral bacteria ferment carbohydrates to produce organic acids which lower the pH and cause the subsurface dissolution of the hydroxyapatite crystals. Under normal physiological conditions (pH7), saliva is supersaturated with calcium and phosphate ions which diffuse into the vacancies created during acid-mediated demineralization episodes (Dowker et al., 1999 and Robinson et al., 2000). The demineralization of enamel (white spot lesions) is a significant problem during and after orthodontic treatment with prevalence 71.1% and various preventive measures have been suggested to minimize the incidence (Derks et al., 2004 and Al Maaitah et al., 2011).
Detailed description
In orthodontic patients, demineralization usually takes place in the form of white or brown spots on the enamel around the brackets and can lead to cavitation (Al Maaitah et al., 2011). White spot lesions compromise esthetics and can be extremely difficult or even impossible to reverse.
Natural remineralization through saliva involving a mineral gain in the surface layer of white spot lesions has little improvement on the esthetic and structural properties of the deeper lesions (Karlinsey et al., 2009 and Cochrane et al., 2010). Management of white spot lesion should involve methods of both preventing demineralization and encourage the remineralization of existing lesions. In both of these processes, the efficacy of fluoride is well established. Fluoride increases the initial rate of remineralization of early enamel lesions. Consequently, it slows down the caries process and arresting the lesion. Fluoride varnish provides a protective coat over the tooth which adheres longer to the tooth surface (Demito et al., 2004 and Ten Cate et al., 2008).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI varnish GC | Active comparator | Drug: MI varnish GCMI Varnish is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. MI Varnish also contains RECALDEN Open the unit-dose package of Varnish. Use the applicator brush to thoroughly mix Varnish . Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue. |
| White Varnish 3M | Active comparator | Drug: White varnish 3MWhite Varnish is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. White Varnish an innovative tri-calcium phosphate. Open the unit-dose package of Varnish. Use the applicator brush to thoroughly mix Varnish . Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age ranging 11-16 years.
- Good general health.
- Exhibiting at least 2 white spot lesion in buccal surface of their teeth.
Key exclusion criteria (5 listed)
- Chronic use of medication causing dry mouth.
- Oral ulcer, ulcerous gingivitis, acute bronchial asthma.
- History of allergic reaction to fluoride or other ingredients in varnish.
- Refusal of the patient to participate in the trial.
- Any previous treatment done for white spot lesion.
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 |
|---|---|---|
| MI varnish GCAlso: Fluoride VarnishMI Varnish GC is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. MI Varnish also contains RECALDENT. Open the unit-dose package of Varnish. Use the applicator brush to thoroughly mix Varnish. Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue. The treatment period for Varnish is minimally 4 hour. | Drug | MI varnish GC |
| White varnish 3MAlso: Fluoride VarnishWhite varnish 3M is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. Clinpro White Varnish contains an innovative tri-calcium phosphate.Open the unit-dose package of Varnish and dispense the entire content onto the round application guide provided with the packet. Use the applicator brush to thoroughly mix Varnish. Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue. The treatment period for Varnish is minimally 4 hour. | Drug | White Varnish 3M |
Primary outcome
Esthetic effect
Time frame: 6 months
Asking patient (yes or No)
1 secondary outcome
Clinical assessment
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 6 Feb 2018.
- 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.
Faculty of Dentistry Cairo University
Al Manyal, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MI varnish GC and White varnish 3M in people with White Spot Lesion of Tooth, run by Cairo University 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 5 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 6 Feb 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esthetic effect (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 6 Feb 2018.