Evaluation of Remin Pro Forte Versus Remin Pro on Treatment of White Spot Lesions Post Orthodontic Treatment

White Spot Lesion Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04017884
• Other study ID #: PHD-CU-2019-07-10
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: January 2020
• Source: Cairo University
• Contact: mennatallah aboulnaga, MD
• Phone: 01016524841
• Email: mennaaboulnaga[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• White Spot Lesion

Intervention

Combination Product:
• Remin Pro Forte
a combination of chemicals with natural products cream .
• Remin Pro
a combination of chemicals

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mineral content	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.	3 months
Primary	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	color improvement	To assess the color improvement of white spot lesions, Digital photographs of the white spot lesions will be taken using digital camera.	3 months