Reminerlization Potential of GSE Gel versusCPP-ACP in Carious White Spot Lesions in Post Orthodontic Patients

Dental Caries Clinical Trial

Official title:

Reminerlization Potential of Grape Seeds Extract Gel Versus Casein Phosphopeptide-amorphous Calcium Phosphate in Carious White Spot Lesions in Post Orthodontic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03966378
• Other study ID #: 607
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 3, 2019
• Est. completion date: May 10, 2020

Study information

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

Clinical Trial Summary

Assess the effectiveness of applying grape seed extract (GSE) gel versus casein phosphopeptide-amorphous calcium phosphate (MI) paste on remineralization of white spot lesion (WSLs) in post orthodontic patients.

Description:

The development of WSLs is a challenging problem in the track of orthodontic treatment. Especially in patients wearing fixed orthodontic appliances, plaque accumulation increases around brackets and bands and the pH on dental surfaces becomes acidic.

These early lesions are willing to remineralization, arrest, reharden and revert to healthy enamel condition through a remineralization process involving the diffusion of minerals into the defective tooth structure. For this purpose various remineralizing agents such as casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and grape seed extract (GSE) have been used.

This research is conducted for early intervention and treatment of the white spot lesions by non-invasive method.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: May 10, 2020
• Est. primary completion date: April 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 35 Years

Eligibility

Inclusion Criteria:

• Presence of at least two WSLs on the labial surfaces of six maxillary anterior teeth that were not present before orthodontic therapy.

Exclusion Criteria:

• Severe or active periodontal disease.

• Patients had received therapeutic irradiation to the head and neck region.

• Patients had participated in a clinical trial within 6 months before commencement of this trial.

• Patients unable to return for recall appointments

• Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).

• Presence of restorations or cavities in any anterior teeth or enamel hypoplasia, dental fluorosis, or intrinsic and extrinsic pigmentation.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Grape seeds extract
Grape seeds extract powder
• Casein-phosphopeptide/amorphous-calcium phosphate
CPP-ACP paste

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative changes of white spot lesions	changes in fluorescence of white spot lesions will be evaluated after reminerlization by using diagnodent device by score (0-20).	evaluation of tooth surface changes at baseline and at 4, 12, and 24 weeks after starting treatment .