Effect of Curodont Repair on Color Change of White Spot Lesions
Comparative Study Using Biomimetic Remineralization Versus Fluoride Varnish In Management Of White Spot Lesion In Post Orthodontic Treated Patient: (Split Mouth Technique ) A Randomized Clinical Trial
1 other identifier
interventional
64
0 countries
N/A
Brief Summary
The aim of this study is to compare the effect of color change between remineralizing agent and guided enamel regeneration in treatment of white spot lesion after orthodontic treatments
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2017
Shorter than P25 for phase_2
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
September 21, 2016
CompletedFirst Posted
Study publicly available on registry
September 26, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedSeptember 26, 2016
September 1, 2016
6 months
September 21, 2016
September 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
change in patient satisfaction
using visual analogue scale from 0-100 (0= not satisfied , 100= totally satisfied)
before, after 3 and 6 months
Secondary Outcomes (1)
change in color shade
before, after 3 and 6 months
Study Arms (2)
Group 2
ACTIVE COMPARATORcurodont repair is a biomimetic regeneration scaffold for remineralization
Group 1
EXPERIMENTALfluoride varnish inhibit progression of white spot lesion
Interventions
composed of biomimetic regeneration scaffold self-assembling peptides (P11-4) used for remineralization
fluoride inhibit the progression of white spot lesion
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
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer, conservative Dentistry Department MTI university
Study Record Dates
First Submitted
September 21, 2016
First Posted
September 26, 2016
Study Start
January 1, 2017
Primary Completion
July 1, 2017
Study Completion
September 1, 2017
Last Updated
September 26, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share