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

Not Applicable

• Conditions: Dental Caries
• Interventions: Other: Grape seeds extract; Other: Casein-phosphopeptide/amorphous-calcium phosphate

• Registration Number: NCT03966378
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-25
• Last Update Submitted: 2019-05-25
• Study First Posted: 2019-05-29
• Last Update Posted: 2019-05-29
• Study Start: 2019-10-03
• Primary Completion: 2020-04-06
• Study Completion: 2020-05-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grape seeds extract	Grape seeds extract	Every week the grape seeds extract (gel) put into the tray and apply it to the upper teeth of the participant.
Casein-phosphopeptide/amorphous-calcium phosphate	Casein-phosphopeptide/amorphous-calcium phosphate	CPP-ACP paste apply to the teeth twice daily.

Primary Outcome Measures

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