Reminerlization Potential of Innovative Biomimetic Material in Caries White Spot Lesions

White Spot Lesion of Tooth Clinical Trial

Official title:

Reminerlization Potential of Innovative Biomimetic Material Versus Casein Phosphopeptide-amorphous Calcium Phosphate in Caries White Spot Lesions "A Randomized Clinical Trial"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03823612
• Other study ID #: donia mahmoud
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

to remineralize the white spot caries lesions after orthodontic treatment , the investigator will use two different materials ( Clinpro tooth creme versus Gc tooth mousse) and will compare between their effects in remineralization of white spot caries lesions.

Description:

Dental caries is the localized destruction of tooth tissues by acids, especially lactic acid, produced by the fermentation of dietary carbohydrates by bacteria in dental plaque. Demineralization can be arrested or reversed when remineralization agents are applied to incipient carious or non-cavitated carious lesions. A large number of therapeutic agents including non-fluoridated products have been developed to promote enamel remineralization. The process of restoring lost mineral ions to the tooth structure and strengthening the lattice work is known as remineralization.

The development of decalcification around orthodontic brackets and bands, commonly called white spot lesions (WSLs), is often observed in patients with poor oral hygiene during treatment .In many instances, these WSLs continue to be visible after the removal of fixed appliances and after natural remineralization. The remineralized enamel crystallites are generally more resistant to decalcification and also have the same orientation as the original enamel crystallites. The early enamel lesions have a potential for remineralization with an increased resistance to further acid challenge, particularly with the use of enhanced remineralization treatments.

Recaldent™ is derived from the milk protein, casein. For many years it has been known that milk and its derivatives have a tooth protective effect. Research has shown that this activity is due to a part of the casein protein called Casein Phosphopeptide (or CPP), which carries calcium and phosphate ions in the form of Amorphous Calcium Phosphate (or ACP) which used in reminerlization of white spot caries lesions.

Clinpro tooth crème (3M ESPE) is a 0.21% w/w sodium fluoride (NaF) anti caries dentifrice that contains 950 ppm fluoride and a functionalized tricalcium phosphate (f-TCP) ingredient.One major advantage of this calcium phosphate system is that it is stable in aqueous environment and also does not affect the fluoride activity added in the dentifrices. Furthermore,it has been suggested that fluoride combination with f-TCP not only provides greater remineralization in terms of microhardness and fluoride uptake, but also decreases the dose of fluoride required to achieve the same degree of remineralization,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: October 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Patients should have at least one white spot caries lesion

• age from 18 to 40 years

• no gender restriction

Exclusion Criteria:

• Patients with a compromised medical history.

• Severe or active periodontal disease

• Patients with developmental hypo-calcified lesions

Related Conditions & MeSH terms

• Dental Caries
• White Spot Lesion of Tooth

Intervention

Drug:
• Clinpro Tooth Creme
The participant will be instructed to Place a pea-sized amount of Clinpro Tooth Crème on a soft bristled toothbrush and brush teeth for at least two minutes then after brushing the patient will rinse out his mouth with water and spit out. It will be used twice daily at first in the morning and before sleep.
• GC tooth mousse
The participant will be instructed to squeeze a small amount of GC Tooth Mousse out onto a clean finger. A cotton tip, swab or custom tray are suitable application methods as it will Applied directly onto his tooth surfaces and leave undisturbed for three minutes then he will be instructed to Spread any residual crème around the mouth with his tongue and hold for a further one to two minutes then the participant will expectorate thoroughly and if possible he should avoid rinsing. Any GC Tooth Mousse remaining in the mouth can be left to gradually dissipate. The participant will be instructed to avoid eating or drinking for 30 minutes following application.

Locations

Country	Name	City	State
Egypt	Donia Mahmoud Abd El Moaty	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	esthetic assessment	Spectrophotometer ( L, a, b) will be used to measure the change in the shade of the white spot lesions during the study	baseline, after 1 month , 3 months and 6 months of the application
Secondary	patient compliance	The participants compliance will be detected by a questionnaire by asking the patient to describe his satisfaction to the total outcome of our intervention by giving a score from 1-10	6 months