White Spot LesionNCT04017884
Evaluation of Remin Pro Forte Versus Remin Pro on Treatment of White Spot Lesions Post Orthodontic Treatment
A study testing Remin Pro Forte and Remin Pro in people with White Spot Lesion, run by Cairo University.
Trial summary
randomized clinical trial to evaluate caries regression, the change in colour and mineral content of the demineralized enamel after treatment with Remin Pro Forte paste (fluoride, hydroxyapatite, xylitol, ginger, and curcuma) and Remin pro cream which contains (fluoride, hydroxyapatite, xylitol) remineralizing agents… Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Remin Pro Forte and Remin Pro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 1 Nov 2020
- 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 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- No systemic disease.
- Has completed fixed orthodontic treatment, brackets debonded.
- Has at least two teeth with white spot lesion.
- Has received conventional periodontal therapy after orthodontic treatment.
- Between the ages of 12 and 25 years of age.
Who cannot join
- Presence of enamel hypoplasia or dental fluorosis.
- Presence of tetracycline pigmentation.
- Periodontal pocketing of 3mm or greater.
- Taking antibiotics.
- Presence of carious cavities.
- Allergy to fluoride gel / varnish being used in study.
- Subjects who had evidence of reduced salivary flow or significant tooth wear
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Caries Regression, Color Improvement and Mineral Content of White Spot Lesions Post-orthodontic Treatment After Remineralization With Remin Pro Forte Versus Remin Pro: A Randomized Clinical Trial
randomized clinical trial to evaluate caries regression, the change in colour and mineral content of the demineralized enamel after treatment with Remin Pro Forte paste (fluoride, hydroxyapatite, xylitol, ginger, and curcuma) and Remin pro cream which contains (fluoride, hydroxyapatite, xylitol) remineralizing agents with the null hypothesis that Remin Pro forte will have the same clinical performance as Remin Pro in remineralizing white spot lesions post-orthodontic treatment.
Read the detailed description
Recently, a remineralizing water based cream containing Hydroxyapatite, Fluoride and Xylitol (Remin pro) has been introduced. It has been claimed that hydroxyapatite fills eroded enamel, fluoride seals dentinal tubules and xylitol acts as an antibacterial agents. This product has been assumed to be suitable for management of dentinal hypersensitivity, prevention of enamel demineralization and promoting remineralization of enamel subsurface lesions. There are few studies regarding the effect of calcium phosphate and hydroxyapatite-based agents on remineralization and optical appearance of White spot lesions following orthodontic therapy.
Recently a new formulation of Remin pro has been introduced called (Remin Pro Forte) with the same components of fluoride, hydroxyapatite, xylitol in addition to two natural products (Ginger, curcuma) with the rationale based behind that they have antibacterial effect against streptococcus mutans in addition to anti-cariogenic effect which is being confirmed in the scientific literature.
Follow up period is selected to be 3 months, which is enough for evaluation of the outcomes (caries regression, color change, mineral content) assessed in this study.
- Conditions
- White Spot Lesion
- Being tested
- Remin Pro Forte, Remin Pro
- Keywords
- Remineralization, caries regression, color improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remin Pro ForteCombination product
a combination of chemicals with natural products cream .
Remin ProCombination product
a combination of chemicals
| Study group | Role | What they receive |
|---|---|---|
| Remin Pro Forte. | Experimental | intervention Receives: Combination Product: Remin Pro |
| Remin pro. | Active comparator | comparator Receives: Combination Product: Remin Pro Forte |
What is being measured
The primary outcome is the main question the study is designed to answer.
caries regression
The assessment will be done by photographic image records and performing ICDAS II scoring on white spot lesions on the image records.
Measured: 3 months
Secondary outcomes (1)
color improvement
To assess the color improvement of white spot lesions, Digital photographs of the white spot lesions will be taken using digital camera.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Jul 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mennatallah aboulnaga, Cairo University
- Investigators
- mennatallah aboulnaga, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017884
- Sponsor's protocol ID
- PHD-CU-2019-07-10
- Status last verified
- Jan 2020
- First submitted
- 10 Jul 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Caries Regression, Color Improvement and Mineral Content of White Spot Lesions Post-orthodontic Treatment After Remineralization With Remin Pro Forte Versus Remin Pro: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04017884
- Acronym / sponsor ID
- PHD-CU-2019-07-10
- Conditions
- White Spot Lesion
- Keywords
- Remineralization, caries regression, color improvement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 12 Jul 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.
randomized clinical trial to evaluate caries regression, the change in colour and mineral content of the demineralized enamel after treatment with Remin Pro Forte paste (fluoride, hydroxyapatite, xylitol, ginger, and curcuma) and Remin pro cream which contains (fluoride, hydroxyapatite, xylitol) remineralizing agents with the null hypothesis that Remin Pro forte will have the same clinical performance as Remin Pro in remineralizing white spot lesions post-orthodontic treatment.
Detailed description
Recently, a remineralizing water based cream containing Hydroxyapatite, Fluoride and Xylitol (Remin pro) has been introduced. It has been claimed that hydroxyapatite fills eroded enamel, fluoride seals dentinal tubules and xylitol acts as an antibacterial agents. This product has been assumed to be suitable for management of dentinal hypersensitivity, prevention of enamel demineralization and promoting remineralization of enamel subsurface lesions. There are few studies regarding the effect of calcium phosphate and hydroxyapatite-based agents on remineralization and optical appearance of White spot lesions following orthodontic therapy.
Recently a new formulation of Remin pro has been introduced called (Remin Pro Forte) with the same components of fluoride, hydroxyapatite, xylitol in addition to two natural products (Ginger, curcuma) with the rationale based behind that they have antibacterial effect against streptococcus mutans in addition to anti-cariogenic effect which is being confirmed in the scientific literature.
Follow up period is selected to be 3 months, which is enough for evaluation of the outcomes (caries regression, color change, mineral content) assessed in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remin Pro Forte. | Experimental | Combination Product: Remin Prointervention |
| Remin pro. | Active comparator | Combination Product: Remin Pro Fortecomparator |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- No systemic disease.
- Has completed fixed orthodontic treatment, brackets debonded.
- Has at least two teeth with white spot lesion.
- Has received conventional periodontal therapy after orthodontic treatment.
- Between the ages of 12 and 25 years of age.
Key exclusion criteria (7 listed)
- Presence of enamel hypoplasia or dental fluorosis.
- Presence of tetracycline pigmentation.
- Periodontal pocketing of 3mm or greater.
- Taking antibiotics.
- Presence of carious cavities.
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 |
|---|---|---|
| Remin Pro Fortea combination of chemicals with natural products cream . | Combination product | Remin pro. |
| Remin Proa combination of chemicals | Combination product | Remin Pro Forte. |
Primary outcome
caries regression
Time frame: 3 months
The assessment will be done by photographic image records and performing ICDAS II scoring on white spot lesions on the image records.
1 secondary outcome
color improvement
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for White Spot Lesion
Active, not recruiting
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
Bracket Bonding, Orthodontic Treatment
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Recruiting
EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Not yet recruiting
S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment
White Spot Lesion of Tooth, Orthodontic Treatment
Recruiting
Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
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.
mennatallah aboulnaga, MD principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Remin Pro Forte and Remin Pro in people with White Spot Lesion, run by Cairo University.
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 5 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 28 Jan 2020. 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 mennatallah aboulnaga, MD (01016524841, mennaaboulnaga@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caries regression (time frame: 3 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 28 Jan 2020.