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

White Spot Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03187548
• Other study ID #: CPP-ACP_whitespots
• Status: Not yet recruiting
• Phase: Phase 1
• First received: June 13, 2017
• Last updated: June 13, 2017
• Start date: July 2017
• Est. completion date: January 2018

Study information

• Verified date: June 2017
• Source: Cairo University
• Contact: Fatma Abdou, Professor
• Phone: 01006739365
• Email: Fatmaabdou[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: January 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

Inclusion Criteria:

• severe crowding

• Increased overjet

• Protruded maxillary base

• Sound maxillary premolars

• medically free

• molar classification class II

• Canine classification class II

Exclusion Criteria:

• spacing of teeth

• Decreased overjet

• Molar classification III Medically compromised patients

• pregnant females

• carious premolars

• hypoplasia

Related Conditions & MeSH terms

• Dental Caries
• Enamel Hypomineralization
• White Spot Lesion

Intervention

Drug:
• Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste
Application of CPP-ACP on one premolar once every 2 weeks for 3 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on enamel surface color	Assessment of the effect of CPP-ACP on enamel surface using ICDAS-II	3 months
Primary	Effect on enamel surface	Assessment of the effect of CPP-ACP on enamel surface using visual analogue scale through digital photograph	3 mnths
Secondary	Surface texture	Assessment of the effect of CPP-ACP on enamel surface texture using scanning electron microscope	3 months
Secondary	Microhardnes	Assessment of the effect of CPP-ACP on enamel microhardness using Vickers hardness test	3 months