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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03187548
Other study ID # CPP-ACP_whitespots
Secondary ID
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
Health authority
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

Study Design


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
See also
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