Evaluation of Remin Pro Forte Versus Remin Pro on Treatment of White Spot Lesions Post Orthodontic Treatment
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
1 other identifier
interventional
40
0 countries
N/A
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2020
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2019
CompletedFirst Posted
Study publicly available on registry
July 12, 2019
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedJanuary 28, 2020
January 1, 2020
3 months
July 10, 2019
January 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
caries regression
The assessment will be done by photographic image records and performing ICDAS II scoring on white spot lesions on the image records.
3 months
Secondary Outcomes (1)
color improvement
3 months
Other Outcomes (1)
mineral content
3 months
Study Arms (2)
Remin Pro Forte.
EXPERIMENTALintervention
Remin pro.
ACTIVE COMPARATORcomparator
Interventions
a combination of chemicals with natural products cream .
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Officials
- PRINCIPAL INVESTIGATOR
mennatallah aboulnaga, MD
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Triple (participant,investigator,outcomes assessor)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
July 10, 2019
First Posted
July 12, 2019
Study Start
July 1, 2020
Primary Completion
October 1, 2020
Study Completion
November 1, 2020
Last Updated
January 28, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share