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

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.

Study Overview

• Status: Unknown
• Conditions: White Spot Lesion
• Intervention / Treatment: Combination product: Remin Pro; Combination product: Remin Pro Forte

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remin Pro Forte.; intervention	Combination product: Remin Pro; a combination of chemicals
Active Comparator: Remin pro.; comparator	Combination product: Remin Pro Forte; a combination of chemicals with natural products cream .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: mennatallah aboulnaga, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Remineralization; caries regression; color improvement
• Other Study ID Numbers: PHD-CU-2019-07-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No