White Spot Lesion
Conditions
Keywords
Remineralization, caries regression, color improvement
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.
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.
Interventions
COMBINATION_PRODUCTRemin Pro Forte
a combination of chemicals with natural products cream .
COMBINATION_PRODUCTRemin Pro
a combination of chemicals
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Triple (participant,investigator,outcomes assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
1. No systemic disease. 2. Has completed fixed orthodontic treatment, brackets debonded. 3. Has at least two teeth with white spot lesion. 4. Has received conventional periodontal therapy after orthodontic treatment. 5. Between the ages of 12 and 25 years of age.
Exclusion criteria
1. Presence of enamel hypoplasia or dental fluorosis. 2. Presence of tetracycline pigmentation. 3. Periodontal pocketing of 3mm or greater. 4. Taking antibiotics. 5. Presence of carious cavities. 6. Allergy to fluoride gel / varnish being used in study. 7. Subjects who had evidence of reduced salivary flow or significant tooth wear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| caries regression | 3 months | The assessment will be done by photographic image records and performing ICDAS II scoring on white spot lesions on the image records. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| color improvement | 3 months | To assess the color improvement of white spot lesions, Digital photographs of the white spot lesions will be taken using digital camera. |
Other
| Measure | Time frame | Description |
|---|---|---|
| mineral content | 3 months | To measure the mineral content of WSLs, the labial surfaces of the selected teeth will be assessed by VistaCam iX using a special head for taking fluorescent images according to the manufacturer's instructions. |
Contacts
Primary Contactmennatallah aboulnaga, MD
Outcome results
None listed