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

Cairo University (CU)

Status: Unknown

Conditions: White Spot Lesion

Treatments: Combination Product: Remin Pro Forte; Combination Product: Remin Pro

Study type: Interventional

Funder types: Other

Identifiers

NCT04017884

PHD-CU-2019-07-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 12 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Remin Pro Forte.

Experimental group

Description:

intervention

Treatment:

Combination Product: Remin Pro

Remin pro.

Active Comparator group

Description:

comparator

Treatment:

Combination Product: Remin Pro Forte