NCT03187548

Evaluation of CPP-ACP Prophylactic Effect on Enamel Surface During Orthodontic Treatment

Evaluation of the Demineralizing Effect on Enamel Surface During Orthodontic Treatment With and Without the Addition of Casein Phosphopeptides-Amorphous Calcium Phosphate (CPP-ACP) on: A Randomized Clinical Trial, Split Mouth Design

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 15 Years – 30 Years
• Healthy volunteers: Accepted

Summary

This study is aiming in preventing the formation of WSL associated with orthodontic treatment which occurs to more than 50% of orthodontically treated patients through applying CPP-ACP on the enamel surface once every 2 weeks for 3 months.

Detailed description

CPP-ACP will be applied on premolars to be extracted in orthodontic patients whose treatment plan indicates extraction of at least 2 premolaes of the maxillary arch. Application will continue on one premolar either the right or left one once every 2 weeks for the first 3 months of the treatment.

Conditions

• White Spot Lesion
• Enamel Hypomineralization

Interventions

Type	Name	Description
DRUG	Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste	Application of CPP-ACP on one premolar once every 2 weeks for 3 months.

Timeline

• Start date: 2017-07-01
• Primary completion: 2017-09-01
• Completion: 2018-01-01
• First posted: 2017-06-15
• Last updated: 2017-06-15

Regulatory

• FDA-regulated drug study